Precision AI Surgical Planning System (PAI-SPS)
Overview
The Precision AI Surgical Planning System (PAI-SPS) is a comprehensive software and hardware solution designed to assist surgeons in the preoperative planning and intraoperative guidance for shoulder replacement surgeries. It leverages artificial intelligence to create detailed 3D models of a patient’s shoulder joint from CT scans, enabling surgeons to visualize and precisely plan implant placement. The system incorporates non-adaptive machine or deep learning algorithms for semi-automatic segmentation and landmark identification from CT scans. Beyond planning, PAI-SPS facilitates the production of custom, patient-specific 3D-printed surgical guides (including Glenoid and Humeral Guides) from biocompatible medical-grade Nylon (Polyamide-12) to accurately transfer the preoperative plan to the operating room, enhancing surgical outcomes and improving the accuracy of implant positioning during total anatomic and reverse shoulder arthroplasty. The software also generates a surgery report and pre-surgical plan data file.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-driven preoperative surgical planning software
- 3D modeling of patient's shoulder joint from CT scans
- Semi-automatic segmentation and landmark identification using AI algorithms
- Patient-specific 3D-printed surgical guides (Glenoid and Humeral Guides)
- Assistance in accurate implant placement and positioning
- Visualization of native anatomy and identification of potential complications
- Generation of surgery report and pre-surgical plan data file
- Intended for total anatomic and reverse shoulder replacement surgery
Use Cases
- Preoperative planning for shoulder replacement surgery
- Intraoperative guidance for shoulder replacement surgery
- Planning for total anatomic shoulder replacement surgery
- Planning for reverse shoulder replacement surgery
- Accurate placement of guide wire into glenoid fossa
- Accurate application of humeral cutting block
What Physicians Need to Know
Leverage the comprehensive 3D visualization capabilities to thoroughly understand patient-specific anatomy and anticipate potential intraoperative challenges. Utilize the patient-specific surgical guides diligently to ensure precise implant positioning, directly translating your detailed preoperative plan into accurate surgical execution. Regularly review the generated surgical reports and plan data files for meticulous pre-surgical preparation and post-operative assessment of adherence to the plan.
The Precision AI Surgical Planning System integrates its software for 3D planning with a hardware component of 3D-printed patient-specific surgical guides. It processes CT scan data for generating detailed 3D models and is approved for use with specific Enovis implant systems. The system currently holds regulatory approvals in Australia, New Zealand, and the United Kingdom, with ongoing applications for broader international regulatory acceptance.
Details
| Category | Surgical AI |
| Pricing | Contact for details — Contact vendor for specific pricing tiers and models |
| Deployment | Hybrid (Software for planning; 3D-printed hardware components for intraoperative use) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The Precision AI Surgical Planning System (PAI-SPS) received FDA 510(k) clearance (K243955) on January 21, 2025. It is indicated for use on adult patients consented for shoulder joint arthroplasty, assisting in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. |
| Integrations | |
| EHR | Not specified |
| Specialties | Orthopedics |
What the Web Says
The Precision AI Surgical Planning System (PAI-SPS) is a medical device designed to assist surgeons in planning and executing shoulder arthroplasty. It uses AI to segment CT scan images, create 3D bone constructs, and allow surgeons to virtually place implants for optimal correction of deformities. The system aims to improve accuracy, enhance patient outcomes, and streamline surgical workflows, with applications extending to patient-specific 3D-printed guides and biomodels.
Overall: PositiveStrengths
- Improves accuracy of implant placement and enhances patient outcomes.
- Reduces variability and saves time compared to manual planning.
- Allows surgeons to simulate different scenarios and virtually test implant sizes.
- Provides patient-specific 3D models for better understanding of anatomy and surgical planning.
- Can reduce surgical complications and speed up recovery times.
- Enhances efficiency and supports better overall patient care.
Limitations
- Surgeons still need to be able to perform procedures without over-reliance on AI, which can be inconsistent or misinformed.
- Professional confidence in AI systems can be an obstacle due to lack of training, insufficient clinical validation, and transparency issues.
- Algorithmic bias across diverse demographics needs to be addressed.
- The opacity of machine learning decision-making processes hinders the development of professional trust.
- Some AI scribe tools, while not directly PAI-SPS, have been noted for inaccuracies or lack of robust features in other medical contexts.
- The system is currently approved for use in Australia, New Zealand, and the United Kingdom, with wider international regulatory approval pending.
Based on reviews from: Innolitics, Precision AI, FDA.report, Capterra, Frontiers, PMC, DeepCura, Becker's Spine Review, Reddit, MDPI, PeekMedu00ae Blog, SpryPT, MedAI Verdict, G2, MedCity News
Last updated: 2026-07-21
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