Spine CAMP™ (1.1)

by Medical Metrics  · Based in United States → — Advance Spine Care with Data-Driven Precision
Neurosurgery Orthopedics Radiology
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Regulatory Status Disclosed

Overview

Spine CAMP™ (1.1) is a fully automated image processing software developed by Medical Metrics, Inc. It is designed for use with X-ray images to aid qualified and licensed healthcare practitioners in measuring and assessing spinal parameters. The software leverages AI technology to provide objective and reproducible metrics for characterizing spine morphology, alignment, and motion.

Spine CAMP™ v1.1 features an updated AI Engine, retrained with additional imaging data to enhance generalization and performance. It includes logic improvements to mitigate potential failure modes and introduces the capability to identify femoral heads in lateral lumbar X-rays for spinopelvic measurements. The software also offers expanded configuration options to customize report outputs based on clinical preferences.

It seamlessly integrates with current clinical workflows, delivering enhanced visualizations and precise, objective X-ray measurements to support clinical decision-making.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated X-ray image processing for spine
  • Measures spinal distances, angles, and displacements
  • Characterizes spine morphology, alignment, and motion
  • Updated AI Engine for enhanced performance
  • Identifies femoral heads for spinopelvic measurements
  • Customizable report outputs
  • Enhanced visualizations of spinal motion
  • Objective and validated spinal segmentation
  • Seamless integration with existing workflows
  • Intuitive and digestible reporting
  • Strain-based fusion assessment

Use Cases

  • Assessing spinal stability
  • Evaluating spinal alignment and degeneration
  • Analyzing spinal fusion and motion preservation
  • Assessing implant performance
  • Supporting clinical decision-making for cervical disc arthroplasty
  • Objective assessment of potential lumbar instability and cervical trauma

What Physicians Need to Know

Evidence Base
Spine CAMPu2122 v1.1 automates the processing of X-ray images to measure spinal parameters like distances, angles, and displacements, aiding in the characterization of spine morphology, alignment, and motion. The radiographic metrics support the assessment of spinal health, including stability, alignment, degeneration, fusion, motion preservation, and implant performance, in accordance with established guidance. The tool leverages AI to digitize plain film radiographs, extracting objective data and comparing findings to well-established criteria from the AMA for ligament laxity. Medical Metrics, the developer, has extensive experience from over 300 spine-related clinical trials.
Clinical Validation Studies
Spine CAMPu2122 underwent software verification and validation testing across multiple datasets, confirming its safety and effectiveness as being substantially equivalent to its predicate device, Spine CAMPu2122 v1.0 (K221632). Spine CAMPu2122 v1.0 was previously deemed substantially equivalent to KIMAX QMAu00ae (K022585), a validated quantitative motion analysis method, and Spine CAMPu2122 has been directly validated against QMA. Bench testing for v1.0 demonstrated statistical correlation and equivalence with the predicate device across a large dataset of cervical and lumbar spine radiographs. The device is FDA 510(k) cleared as a Class II medical device (K231668).
Differential Diagnosis Support
The tool provides metrics for assessing spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance, helping to characterize spine morphology, alignment, and motion. It aids in objectifying mechanical back pain and assessing ligament laxity, improving the evaluation of subtle instability and pseudoarthrosis. Spine CAMPu2122 delivers quantitative reports on spinal subluxations, hyper-mobilities, and hypo-mobilities from neutral lateral and flexion-extension X-rays.
Guideline Update Frequency
While a specific update frequency for guidelines is not stated, Spine CAMPu2122 v1.1 features an updated AI Engine, retrained with additional imaging data and logic improvements to enhance generalization and performance. Medical Metrics also publishes 'SpineCAMP Chronicles' to disseminate news and updates related to the platform.
Clinical Workflow Integration
Spine CAMPu2122 is designed for seamless integration into existing clinical workflows, delivering enhanced visualizations and objective X-ray measurements. X-ray images are sent from PACS to Spine CAMP's AI engine for analysis, and the resulting enhanced imaging and reports are returned in line with the original imaging, viewable with a standard DICOM viewer, without requiring new interfaces. The analysis provides instantaneous results to the surgeon.
Physician Tip

Spine CAMPu2122 offers objective, AI-powered analysis of spinal X-rays, providing precise measurements of alignment and motion that can significantly augment clinical decision-making, especially for assessing spinal instability, degeneration, and post-operative status. Leverage the enhanced visualizations and quantitative reports to support your diagnostic and treatment planning, and to facilitate patient education and prior authorization processes. Remember that while the tool provides valuable data, it is a support tool and does not replace clinical judgment. Focus on integrating its objective metrics with your comprehensive patient assessment.

Spine CAMPu2122 is designed for seamless integration with existing PACS environments. It operates by receiving X-ray images via a standard DICOM send tool and returns enhanced imaging and reports directly into your native system, viewable with a standard DICOM viewer. This eliminates the need for new interfaces and streamlines the workflow for image analysis and reporting.

Details

Category Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentWeb-portal (Software as a Medical Device - SaMD)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Spine CAMP™ (1.1) received FDA 510(k) clearance (K231668) on July 7, 2023, as a Class II medical device under regulation 21 CFR 892.2050, with product code QIH (Medical Image Management And Processing System).
Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics, Radiology

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Press & Coverage

Innolitics
Spine CAMPu2122 (1.1) Cleared Special
Spine CAMPu2122 (1.1) received FDA clearance on July 7, 2023, as an automated radiological image processing software. It utilizes artificial intelligence, including nonadaptive machine learning algorithms, to analyze medical images.
2023-07
X-ray Interpreter
Spine CAMPu2122 (1.1) | FDA Radiology AI Device - X-ray Interpreter
Spine CAMPu2122 (1.1) is an automated software by Medical Metrics, Inc. that analyzes X-ray images of the lumbar and cervical spine to provide measurements and visualizations of spinal alignment, stability, degeneration, and motion. It was cleared by the FDA on July 7, 2023.
2023-07
Orthogonal
SaMD Cleared by the FDA: The Ultimate Running List
Spine CAMPu2122 (1.1) is included in a comprehensive list of FDA-cleared Software as a Medical Device (SaMD), with its clearance date noted as July 7, 2023, for radiology applications.
2024-10
accessdata.fda.gov
FDA 510(k) Premarket Notification for Spine CAMPu2122 (1.1)
The FDA reviewed the 510(k) premarket notification for Spine CAMPu2122 (1.1) and determined it to be substantially equivalent to predicate devices, with the primary differences being an updated AI Engine for improved generalization and performance.
2023-07
FDA.report
MEDICALVR BV FDA Filings
Spine CAMPu2122 (1.1) is listed among MEDICALVR BV's FDA filings with product code QIH and a clearance date of July 7, 2023.
2023-07

Videos

Product demos, reviews, and walkthroughs for Spine CAMP™ (1.1).

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Frequently Asked Questions

Spine CAMPu2122 (1.1) is designed for seamless integration into current clinical workflows, providing enhanced visualizations and quantified metrics directly from standard X-ray images. It automates the measurement of spinal parameters, aiming to reduce the subjectivity and potential errors associated with manual measurements.
Spine CAMPu2122 (1.1) is FDA 510(k) cleared as a Class II medical device under regulation 21 CFR 892.2050, indicating its safety and effectiveness for clinical use in the USA. As a medical device, it is required to comply with various regulations including registration, listing, labeling, and medical device reporting, which inherently involve adherence to healthcare data protection standards.
Spine CAMPu2122 (1.1) is intended as a support tool and does not replace clinical judgment, requiring human interpretation of its outputs. It is also restricted to skeletally mature patients aged 18 and above, limiting its application in pediatric cases.
Alternatives to Spine CAMPu2122 (1.1) primarily involve traditional manual radiographic assessment methods, which can be more subjective and prone to variability compared to automated AI analysis. Other advanced imaging systems and robotic navigation platforms exist for spine imaging and surgical planning, though they may serve different primary functions or offer complementary capabilities.
The provided search results do not explicitly detail the specific pricing model for Spine CAMPu2122 (1.1). However, similar AI software platforms in the medical imaging space often utilize credit-based pricing with various tiers, which can range from free to monthly subscriptions depending on usage volume. For precise pricing information, direct inquiry with Medical Metrics, Inc. would be necessary.
Spine CAMPu2122 (1.1) is particularly beneficial for assessing spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance in lumbar and cervical spine X-ray images. It provides objective metrics and enhanced visualizations of spinal motion, aiding in the diagnosis of conditions such as subluxations, hyper-mobilities, and hypo-mobilities.
Spine CAMPu2122 v1.1's AI has been retrained with additional imaging data to enhance generalization and performance, incorporating logic improvements to mitigate potential failure modes. It underwent software verification and validation testing across multiple datasets, demonstrating functionality and has been deemed substantially equivalent to its predicate device, Spine CAMPu2122 v1.0, and directly validated against QMA (Quantitative Motion Analysis) technology.

Compare Spine CAMP™ (1.1)

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Butterfly iQ3 Ultrasound System vs Spine CAMP™ (1.1)
Clinical Decision Support & Reference Adjacent · 60/100
These tools are adjacent in their comparability, both leveraging AI for medical imaging analysis but differing significantly in their core technology and application. Butterfly iQ3 is a handheld,…
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Spine CAMP™
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Spine CAMP™ is an intelligent analytical platform that utilizes AI to provide fully-automated, objective, and validated analysis of spinal X-ray images, delivering precise metrics and actionable insights to support clinicians in spine care.
Contact for pricing

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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