Alpha Control Liner System (ACLS)

by Coapt  · Based in United States → — The next-generation prosthetic interface solution for upper extremity pattern recognition users.
Orthopedics Physical Medicine & Rehab Plastic Surgery

Contact for pricing
Regulatory Status Disclosed

Overview

The Alpha Control Liner System (ACLS) by Coapt is an innovative prosthetic interface designed to work seamlessly with the Coapt Gen2 Complete Control System. It features embedded electrodes and leads within a gel-covered locking liner, simplifying the complex process of electrode placement. Developed in collaboration with Shirley Ryan AbilityLab, the ACLS improves myoelectric signal consistency by minimizing electrode lift-off, which is crucial for accurate pattern recognition. This leads to enhanced intuitive control, allowing users to achieve a greater range of motion and more natural prosthetic movements. The system also prioritizes patient comfort, offering improved socket comfort and easier donning and doffing of the prosthesis. It is available for both transradial and transhumeral upper limb prosthesis wearers.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Embedded electrodes and leads in a gel-covered locking liner
  • Simplifies electrode placement and fabrication process
  • Improves signal consistency by minimizing electrode lift-off
  • Enhances user control and allows greater range of motion (e.g., 11% greater elbow ROM)
  • Improved socket comfort and easier donning & doffing for patients
  • Compatible with Coapt Gen2 Complete Control System
  • Available for transradial and transhumeral users
  • Integrated electrode design ensures consistent contact and improved signal fidelity

Use Cases

  • Improving intuitive control of upper limb prostheses
  • Enhancing comfort and ease of use for prosthesis wearers
  • Simplifying the fitting and evaluation process for prosthetists and clinicians
  • Providing a consistent and reliable interface for myoelectric pattern recognition systems
  • Facilitating natural movement intent decoding for bionic upper limbs

What Physicians Need to Know

Mobile App-Based Personalization
The Alpha Control Liner System integrates with the Coapt Gen2 Complete Control System, which can be fine-tuned and personalized using a mobile application. This allows users to recalibrate and optimize their prosthetic control on the go.
Physician Tip

For upper limb prosthetists, the Alpha Control Liner System (ACLS) simplifies the fitting process by eliminating complex electrode placement and improving signal consistency through embedded electrodes. This leads to more reliable myoelectric signal capture for pattern recognition, enhancing intuitive control and comfort for patients using myoelectric prostheses. Practitioners can expect an easier fitting and evaluation process with less time spent on adjustments, while patients may experience increased device comfort, a wider range of motion, and an expanded functional envelope. It is designed for external prosthetic fittings of upper limbs.

The Alpha Control Liner System is designed to integrate exclusively with the Coapt Gen2 Complete Control System, which utilizes machine learning and AI for pattern recognition to decode muscle signals for intuitive prosthetic control. It serves as an alternative to traditional socket-embedded electrode systems. The system is compatible with most upper limb powered prosthetic components supported by Coapt Complete Control Pattern Recognition (Gen2).

Details

Category Neurology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing
DeploymentIntegrated as an add-on component within the prosthetic arm
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Alpha Control Liner System (ACLS) received FDA 510(k) clearance (K223738) on January 11, 2023, as a Class II cutaneous electrode device (Product Code GXY, Regulation Number 21 CFR 882.1320). It is intended for use in conjunction with the Coapt Complete Control System Gen2 for external prosthetic fittings of the upper limbs.

Integrations
EHR Not specified
Specialties Orthopedics, Physical Medicine & Rehab, Plastic Surgery

What the Web Says

The Alpha Control Liner System (ACLS) is a next-generation prosthetic interface developed by Coapt and WillowWood, designed for upper limb myoelectric prostheses. It aims to improve user control and comfort by embedding electrodes and leads directly into a gel-covered locking liner, simplifying electrode placement and ensuring consistent signal capture. The system is intended to work exclusively with the Coapt Gen2 Complete Control System, which uses machine learning for intuitive prosthetic control.

Overall: Mixed

Strengths

  • Improves user control and allows for greater elbow range of motion.
  • Eliminates the complex process of electrode placement, simplifying the fitting and fabrication process for prosthetists.
  • Enhances signal consistency by minimizing electrode lift-off, leading to better functional control.
  • Offers improved socket comfort and easier donning and doffing for patients.
  • Accommodates fluctuating edema throughout the day without interrupting suction.
  • Biocompatibility tested for healthy skin contact.

Limitations

  • Increased power consumption compared to its predicate device, the Complete Control System Gen2.
  • Some users of WillowWood Alpha liners (not specifically ACLS) have reported issues with liners losing shape or degrading internally within a few months.
  • Only custom on the inside, which may not properly conform to significantly unique limb shapes, potentially leading to discomfort or the need for alternative liners.
  • Requires annual physician visits for continued use and prescription affirmation due to medical necessity and coding requirements.
  • The electrodes are made with stainless steel containing nickel, which may be an issue for patients with nickel sensitivity or allergy.
  • Exclusively designed to work with the Coapt Complete Control System Gen2; use with other products may void the warranty and negatively affect performance.

Based on reviews from: accessdata.fda.gov, Reddit, YouTube, Ortho Europe, The O&P EDGE Magazine, PR Newswire, WillowWood, Hanger, Massons Healthcare

Last updated: 2026-07-17

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate Alpha Control Liner System (ACLS)

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Videos

Product demos, reviews, and walkthroughs for Alpha Control Liner System (ACLS).

Loading videos...

View all on YouTube

Frequently Asked Questions

The Alpha Control Liner System (ACLS) enhances myoelectric prostheses by integrating electrodes that capture muscle signals, which are then transmitted to a pattern recognition system like Coapt Gen 2 Controller. This system uses machine learning (AI) to decode user intentions, providing more intuitive and precise control of the prosthetic limb. This leads to improved functional control, increased comfort, and a wider range of motion for patients.
AI components integrated with medical devices like ACLS are regulated by the FDA, often categorized as Software as a Medical Device (SaMD). The FDA evaluates these products based on intended use and patient risk, with specific guidance for adaptive AI algorithms that can change over time, requiring premarket review and ongoing monitoring. Manufacturers must ensure quality systems and good machine learning practices are in place.
While ACLS is a leading solution, other AI-driven advancements in prosthetics include adaptive liners like Roliner, which can learn patient preferences and adjust fit in real-time using AI. AI is also being used with neural interfaces for more natural movement control and in 3D printing for customized prosthetic components. These technologies aim for seamless integration and real-time adaptation.
The cost of implementing AI in healthcare, including for medical devices, can range significantly, with complex AI-driven platforms potentially costing $70,000 to over $250,000, or even $100,000-$500,000 for algorithm development alone. These costs cover development, integration, regulatory approval, and ongoing maintenance, which can be 15-20% of the initial investment annually. While specific pricing for the AI within ACLS is not detailed, the overall cost of AI integration can be substantial.
Current limitations of AI in prosthetics can include challenges with interpreting highly complex or variable myoelectric signals, which can affect real-time adaptation and control precision. While AI aims for intuitive control, some specific movements or multi-functionality might still be limited, and the system's learning curve can vary among patients. Ensuring consistent electrode-to-skin contact is crucial for robust signal capture, and issues like volume fluctuations can impact reliability.
For AI systems processing sensitive patient data like myoelectric signals, robust data privacy and security measures are critical. Healthcare AI solutions are expected to adhere to regulations like HIPAA, which mandates secure handling of protected health information. This typically involves data encryption, anonymization, and strict access controls to prevent unauthorized access or breaches.
Future AI advancements for prosthetic liner systems are expected to focus on even more seamless integration with the user's nervous system, real-time adaptation to gait and habits, and predictive capabilities for more natural movement. AI-driven 3D printing will likely further improve customized fit and affordability, and adaptive algorithms will continue to learn and improve over time. This could lead to prosthetics feeling more like a natural extension of the body.

Related Tools

Cercare Medical Oncology Virtual Expert
Cercare Medical
Neurology AI
Cercare Medical's Oncology Virtual Expert is an AI-powered brain tumor segmentation module that provides fast, consistent, and semi-automated tumor analysis from standard MRI data, designed for on-premise deployment within existing clinical radiology workflows.
CoLumbo C-Spine
Smart Soft Healthcare AD
Clinical Decision Support & Reference
CoLumbo C-Spine is an AI-powered software that processes and analyzes cervical spine MRI exams, assisting clinicians in diagnosis and assessment.
MeRT System
Wave Neuroscience
Mental & Behavioral Health AI
MeRT (Magnetic e-Resonance Therapy) is an advanced, personalized form of TMS that uses your own brainwave data to guide treatment. It's a non-invasive, drug-free option designed to help the brain communicate more efficiently so symptoms of conditions like depression, anxiety, PTSD, TBI, autism, and more can improve.
Brainomix 360 Hyperdensity
Brainomix Limited
Neurology AI
Brainomix 360 Hyperdensity is an AI-powered neuroimaging software tool that detects and quantifies brain hyperdensities on CT scans, forming a crucial part of the Brainomix 360 Stroke platform for rapid and accurate stroke assessment.
SOMNUM
HoneyNaps
Clinical Decision Support & Reference
SOMNUM is an AI-enabled medical software tool by Honeynaps Co., Ltd. that provides comprehensive sleep analysis to aid in the diagnosis and management of sleep disorders.
DETECT-ME/CFS project
DETECT-ME/CFS project (ME/CFS Research Foundation)
Clinical Decision Support & Reference
The DETECT-ME/CFS project is developing an AI-supported clinical decision support system to improve the rapid and reliable diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

See all Neurology AI tools →

More from Coapt

COMPLETE CONTROL System Gen2
Coapt
Neurology AI
Coapt's COMPLETE CONTROL System Gen2 uses AI and machine learning for intuitive, natural control of upper-limb prosthetics, enhancing functionality for individuals with limb loss or difference.

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
AI Tool Finder
AI-powered search. Results may not be comprehensive.