(140 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 consolemounted 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.
Here's a summary of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria in a table format. Instead, it describes general performance goals and how they were met in comparison to a previous version of the device and other predicates.
| Performance Metric | Acceptance Criteria (Not explicitly stated as numerical, inferred from study) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Lumbar Measurements | Comparable accuracy and repeatability to previously-cleared KineGraph VMA System (K112109) | "The accuracy and repeatability studies included in the submission of the previously-cleared version of the KineGraph VMA System (K112109) for lumbar measurements were re-run with the modified device." |
| "The modified KINEGRAPH VMA™ software... performed according to specifications and equivalently to the previously-cleared device..." | ||
| Cervical Measurements (New) | Met specifications (implied) | "Accuracy and repeatability testing was performed for the new cervical measurements." |
| "The modified KINEGRAPH VMA™ software... performed according to specifications..." | ||
| Intervertebral Translation (New) | Met specifications (implied) | "Accuracy and repeatability testing on the new function to produce measurements of intervertebral translation in millimeter units was performed." |
| "The modified KINEGRAPH VMA™ software... performed according to specifications..." | ||
| Software Requirements (SWRS) | Each element to be met | "Each element of the Software Requirements Specifications (SWRS) was tested and found to meet the requirements." |
| Safety and Equivalence | No new issues of safety or effectiveness compared to predicates | "The minor technological differences... raise no new issues of safety or effectiveness. Validation and verification data (including software validation) demonstrate that the subject device functions as intended, and performs functions substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- "The accuracy and repeatability studies included in the submission of the previously-cleared version of the KineGraph VMA System (K112109) for lumbar measurements were re-run with the modified device."
- "Accuracy and repeatability testing was performed for the new cervical measurements."
- "Accuracy and repeatability testing on the new function to produce measurements of intervertebral translation in millimeter units was performed."
However, the specific sample size (number of patients/cases) used for these accuracy and repeatability tests (which serve as the "test set" for performance evaluation) is not explicitly mentioned in this document.
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing ground truth in the performance studies.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done comparing human readers with and without AI assistance. The testing focuses on the device's accuracy and repeatability, and its equivalence to predicate devices, rather than human performance improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, standalone performance testing was conducted. The document states:
- "The accuracy and repeatability studies... for lumbar measurements were re-run with the modified device."
- "Accuracy and repeatability testing was performed for the new cervical measurements."
- "Accuracy and repeatability testing on the new function to produce measurements of intervertebral translation in millimeter units was performed."
These studies assess the device's inherent measurement capabilities (accuracy and repeatability) independently, without considering a human-in-the-loop scenario. The KINEGRAPH VMA™ software itself processes the digital image files to generate quantitative assessments and reports.
7. The Type of Ground Truth Used
The type of ground truth used for the accuracy and repeatability studies is not explicitly defined in the document. Given the nature of "accuracy and repeatability" for measurement devices, it typically implies comparison against:
- Highly precise measurements made by a gold-standard method.
- Measurements derived from phantom studies with known values.
- Consensus measurements from highly experienced human experts (though not explicitly stated here).
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. This is typical for a 510(k) submission where the focus is on verification and validation of the finished device, and the specifics of model training (if applicable to the type of algorithm) are not usually required in this summary. The device appears to be an image processing and measurement software rather than a deep learning AI model that would typically have a distinct training phase described in this way.
9. How the Ground Truth for the Training Set Was Established
Since no information about a training set or its sample size is provided, the method for establishing its ground truth is also not mentioned.
§ 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).