(24 days)
The VMA software is a quantitative imaging software application intended to be used to process any diagnostic imaging modality except mammography from digital image files in DICOM format. It is designed for physicians and clinical professionals who are interested in the analysis of alignment and motion in medical images, particularly in musculoskeletal images of the spine. VMA software permits users to review static and dynamic digital lumbar, thoracic, and cervical spine images. In the case of fluoroscopic images, these are 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. VMA software also facilitates quantitative assessment of vertebral alignment and motion in digital medical images. Information about the alignment and motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts, charts, and text.
The subject device consists of the following components and accessories: VMA™ software (for data transfer, post-image processing and analysis), and its accessory device, the MOTION NORMALIZER™ patient handling and data collection device, which is comprised of the MOTION NORMALIZER Upright and Table devices (for patient assistance during image acquisition), and Control Console (for user interface during imaging).
The subject VMA™ software, and its accessory device, the MOTION NORMALIZER patient handling and data collection device, operate as a system ("the VMA™ System") in conjunction with other commercially-available accessory devices to produce quantitative analysis of inter-vertebral motion in adult patients.
None of the software associated with the subject device performs functions that create radiographic images, nor does the software control, operate, or govern the functionality of the imaging device (i.e., C-Arm Fluoroscopy Device).
With respect to the MOTION NORMALIZER™ hardware, this hardware is configured to assist with lumbar and cervical data collection while images are captured with a standard fluoroscope, and this remains unchanged in the modified device relative to the cleared system (K133875). The additional inclusion of the ability to process thoracic images in the modified device pertains to a new ability to process thoracic images that come from a source other than the MOTION NORMALIZER™ hardware.
Image processing operators, who are Ortho Kinematics, Inc. employees, operate the VMA™ software to process images and facilitate template placement for the prescriber. Prescriber users are able to access processed images 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.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the specified format. It's important to note that the provided text is a 510(k) summary, which often focuses on substantial equivalence rather than detailed clinical study outcomes. Therefore, some requested information might be very general or not explicitly stated.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with specific numeric thresholds for performance metrics. Instead, it refers to performance data and validation/verification testing. The acceptance criteria can be inferred as the successful completion of these tests and the device functioning "as intended."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Compliance with Recognized Standards | |
| IEC 60601-1: Medical Electrical Equipment- Part 1 General requirements for Basic Safety and Essential Performance (2012) | The VMA™ system was "designed and developed in accordance with FDA regulations, including validation and verification testing per FDA recognized standards." In all instances, the subject system functioned "as intended." |
| IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General requirements for safety - Collateral Standard: Electromagnetic Compatibility - requirements and tests (2007) | |
| IEC 60601-1-3: Medical electrical equipment. Part 1: General requirements for safety; Part 1-2: Collateral Standard: Radiation protection in diagnostic X-ray equipment (2013) | |
| IEC 60601-1-6: Medical electrical equipment. Part 1: General requirements for safety; Part 1-4: Collateral Standard: Usability (2013) | |
| IEC 60601-2-54: Medical electrical equipment. Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (2009) | |
| NEMA PS 3.1 - 3.20: Digital Imaging and Communications in Medicine (DICOM) Set (2017) | |
| Repeatability and Accuracy | Repeatability and accuracy testing was performed for the integrated system. In all instances, the subject system functioned "as intended." |
| Software Validation | Software validation testing was performed, and documentation was provided for "moderate level of concern software." The device performs functions "substantially equivalent" to the predicate device, and validation/verification data demonstrates it functions "as intended." |
| Substantial Equivalence (Overall performance relative to predicate) | The subject system has the "same intended use and similar indications for use, technological characteristics, and principles of operation as the company's own identified predicate device." Minor technological differences "raise no new or different questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for any specific "test set" in the context of clinical performance or diagnostic accuracy. The testing mentioned (repeatability, accuracy, software validation) generally refers to engineering and software validation, not necessarily a clinical study with a defined patient test set size. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The document focuses on technical validation and comparison to a predicate device, not on diagnostic accuracy based on expert ground truth.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods are typically associated with clinical studies involving human interpretation or labeling, which are not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study is mentioned. The device is a "quantitative imaging software application" designed to facilitate assessment for "physicians and clinical professionals," but there's no study presented here that evaluates human reader improvement with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The document describes the VMA software, which performs "quantitative assessment of vertebral alignment and motion" and generates "motion analysis reports." This implies a standalone algorithmic function for measurement generation. The "Image processing operators, who are Ortho Kinematics, Inc. employees, operate the VMA™ software to process images and facilitate template placement for the prescriber" indicates a human-in-the-loop for template placement. However, the subsequent "Quantitative graphical output report generation" suggests the measurements themselves are algorithmically derived from the placed templates. The "repeatability and accuracy testing" performed on the "integrated system" would likely encompass the standalone performance of the measurement algorithms once templates are placed.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the repeatability and accuracy testing mentioned, the type of ground truth is not explicitly stated. Given it's a quantitative measurement device for alignment and motion, the ground truth would likely be a highly precise, perhaps manually derived or phantombased, measurement of the actual alignment and motion against which the device's measurements are compared. It's not explicitly stated to be expert consensus, pathology, or outcomes data in the context of diagnostic performance.
8. The Sample Size for the Training Set
No information regarding a training set or its sample size is provided. This 510(k) summary focuses on the modified device and its substantial equivalence to a predicate, not on a new AI model development cycle.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the document, there is no information on how its ground truth would have been established.
§ 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).