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ViMove2 is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

ViMove2 is a wireless electronic device used by healthcare professionals to accurately measure, record and analyze movement and muscle activity of the lower back. The device obiectively measures, records and analyzes angular movement and muscle activity.

Under the direction of the healthcare professional, the software quides the patient through a series of dynamic movements and static postures in standing and sitting positions. ViMove2 then measures the range of motion and muscle activity, streams the data live via BTLE to a host device, e.g. PC, tablet or smart phone, and generates a personalized assessment report including comparisons to normative values.

ViMove2 is comprised of the following key components:

• · 4 Wireless Sensors (2 movement and 2 muscle activity)
• · Disposable Application Pads for attaching sensors to the patient.
• · ViMove software package

The provided text describes a 510(k) submission for the ViMove2 device, which is a wireless system for measuring movements and muscle activity of the lower back/lumbar spine. The submission aims to demonstrate substantial equivalence to a predicate device (ViMove, K142494).

However, the provided text does not contain acceptance criteria or detailed results of a study proving the device meets specific performance criteria beyond general compliance with standards. It states that "testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture," but it does not present the specific acceptance criteria for these assessments or the numerical results from such testing.

Therefore, I cannot fulfill all parts of your request with the information provided. I will fill in the available information and indicate where data is missing from the text.

Acceptance Criteria and Device Performance (Based on available information)

The document primarily focuses on establishing substantial equivalence for the ViMove2 device to its predicate ViMove, emphasizing changes in size, components, and wireless technology. It mentions that "testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture," but does not provide specific quantitative acceptance criteria or the reported performance data against such criteria.

Study Details (Based on available information):

The document mentions "testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture," but it doesn't provide specific details about this "validation testing" that would allow us to answer all your questions.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided. The document states "testing was performed," but does not specify the number of subjects or the data collection methodology (retrospective/prospective, country of origin).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not provided. The document does not describe how the ground truth for the "validation testing" was established, nor does it mention the involvement or qualifications of experts for this purpose.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not provided. No details on adjudication methods for establishing ground truth are mentioned.

4. 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:

   • Not applicable/Not provided. The ViMove2 device is described as a measurement and reporting tool for movement and muscle activity, not an AI-assisted diagnostic imaging device that typically undergoes MRMC studies. The document does not mention any studies evaluating human reader improvement with the device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The document implies that the device is a standalone measurement system that provides objective data and reports. The "validation testing" would likely represent standalone performance, but the specific metrics and results are not provided. The device quantifies movement and muscle activity; it's not an "algorithm" in the sense of an AI model interpreting complex data for a diagnosis.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not explicitly stated/Provided. For ROM measurements, ground truth is typically established using highly accurate motion capture systems or goniometers. The document only mentions that testing was done to validate ROM and posture assessment but does not specify the ground truth method.

7. The sample size for the training set:

   • Not applicable/Not provided. The ViMove2 device is a sensor-based measurement system, not a machine learning/AI device that requires a "training set" in the typical sense for algorithm development. If there was any internal calibration or model fitting, the details are not provided in this public summary.

8. How the ground truth for the training set was established:

   • Not applicable/Not provided. (See point 7).

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