(28 days)
The KINEGRAPH VMA™ software is a quantitative imaging software application intended to be used to process digital image files. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images of the spine. KINEGRAPH VMA™ software permits users to review static and dynamic digital lumbar and cervical spine images acquired with the assistance of the MOTION NORMALIZER™ patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. KINEGRAPH VMA™ software also facilitates quantitative assessment of vertebral motion in digital medical images. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts, and text.
The subject device consists of the KINEGRAPH VMA™ software that analyzes images from the MOTION NORMALIZER™ on an Off-the-Shelf ("OTS") imaging workstation. The MOTION NORMALIZER patient handling and data collection device is an accessory device to the KINEGRAPH VMA™ software that is used to assist with subject lumbar bending and data collection while images are captured with a standard fluoroscope. The MOTION NORMALIZER is comprised of two powered, electromechanical patient handling devices connected to and controlled by a console-mounted OTS computer running custom software connected to various OTS hardware accessories. The subject system is able to capture and record radiographic image data, as well as data from the patient handling devices, and to output this data into DICOM compatible digital image files for analysis using the KINEGRAPH VMA™ software. Once images have been created, they can be uploaded to online servers using running KINEGRAPH VMA™ software using an internet connected computer. All software operation and data storage that occurs subsequent to uploading occurs via online servers running KINEGARPH VMA software. Image processing operators, who are Ortho Kinematics, Inc. employees, operate the KINEGRAPH VMA™ software to process images and facilitate template placement for the prescriber. Prescriber users are able to access processed image and measurement results via an online account administered by Ortho Kinematics, Inc. Prescriber users are able to configure account settings that enable the prescriber to be alerted any time specific user-defined measurement thresholds are exceeded.
The provided document, K133875, is a 510(k) summary for the KINEGRAPH VMA™ (Vertebral Motion Analyzer) Software and its accessory device, the MOTION NORMALIZER™ Patient Handling and Data Collection Device (Version 2.2). This special 510(k) is for a modification to a previously cleared device (Version 2.0).
Based on the provided text, the document states: "Validation and verification data (including software validation) demonstrate that the subject device functions as intended, and performs functions substantially equivalent to the predicate device." However, specific acceptance criteria and detailed study results meeting those criteria are not explicitly outlined in the provided pages of the 510(k) summary. The document mentions "repeatability and accuracy testing was performed for the integrated system" and concludes that "In all instances, the KINEGRAPH VMA ™ software and its accessory device, the MOTION NORMALIZER ™, functioned as intended." However, it does not specify what "intended" means in terms of quantifiable metrics or acceptance values.
Therefore, many of the requested details cannot be extracted directly from this summary.
Here's a breakdown of what can and cannot be derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| KINEGRAPH VMA™ software and MOTION NORMALIZER™ system functionality | The device functions as intended and performs substantially equivalent to the predicate device (K130743 version 2.0). | "In all instances, the KINEGRAPH VMA ™ software and its accessory device, the MOTION NORMALIZER ™, functioned as intended." "Validation and verification data (including software validation) demonstrate that the subject device functions as intended, and performs functions substantially equivalent to the predicate device." |
| Repeatability | Not explicitly stated in quantifiable terms in this document. | "repeatability... testing was performed for the integrated system." |
| Accuracy | Not explicitly stated in quantifiable terms in this document. | "accuracy testing was performed for the integrated system." |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided 510(k) summary.
- Data Provenance: Not specified in the provided 510(k) summary (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- The document describes the KINEGRAPH VMA™ as a quantitative imaging software application that assists physicians and clinical professionals, and "Image processing operators, who are Ortho Kinematics, Inc. employees, operate the KINEGRAPH VMA™ software to process images and facilitate template placement for the prescriber." Prescriber users access processed images and measurement results. This implies a human-in-the-loop system where human operators use the software.
- However, no MRMC comparative effectiveness study is mentioned, nor is any effect size for human improvement with AI assistance. The submission focuses on demonstrating substantial equivalence to a previous version of the device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The text indicates that "Image processing operators... operate the KINEGRAPH VMA™ software to process images and facilitate template placement." This suggests a human-in-the-loop scenario rather than a standalone algorithm performance evaluation. No standalone performance metrics are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. The summary mentions "repeatability and accuracy testing" but does not detail how the "true" values for these tests were established.
8. The sample size for the training set:
- Not specified. The document describes a "verification and validation testing" process, but does not provide details about a training set, which is more relevant for machine learning systems. This device processes images but isn't explicitly described as a machine learning/AI device in the sense of needing a distinct "training set" in the context often associated with such algorithms. It's more about image processing and measurement.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, as no training set details are provided.
Summary of Limitations:
This 510(k) summary is for a modification (version 2.2) of an already cleared device (version 2.0) and focuses heavily on demonstrating substantial equivalence rather than providing detailed performance studies with explicit acceptance criteria and extensive ground truth details for a novel device. The "Performance Data" section is very high-level, stating the device "functioned as intended" without quantifying what "intended" means in terms of performance metrics. The details typically requested for AI/ML device evaluations regarding training data, ground truth establishment, expert involvement, and rigorous statistical studies (like MRMC) are not present in this document.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).