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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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ViMove 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.

ViMove is comprised of five key components:

• 4 Wireless Sensors (2 for movement and 2 for muscle activity)
• Disposable Application Pads for holding the wireless sensors. movement (DAP-M) and muscle (DAP-E) sensors
• Recording and Feedback Device (RFD) is worn in the patient's pocket or within one meter of the sensors
• Recharging Cradle
• ViMove software package

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes the ViMove device as "substantially equivalent" to predicate devices, particularly the Insight Discovery and Vicon. The performance testing focused on proving this substantial equivalence rather than fulfilling specific numeric acceptance criteria for novel claims.

• Non-invasive medical device
• Surface Electromyography (compared to Insight Discovery)
• Provides Real-time biofeedback
• Energy detected from muscle activity only (not delivered)
• Wireless Inclinometer
• Rechargeable batteries in wireless sensors (compared to Insight Discovery, Vicon N/A)
• ISM band - 2.4GHz (compared to Insight Discovery, Vicon N/A)
• Real-time objective measurement of Range of Motion
• Dedicated Software
• Report generated for health care professional
• ABS used for Case (compared to Insight Discovery, Vicon No)
• Device used on Spine
• Isolated USB/Ethernet to connect to PC |
  | Measurement Capabilities | Assessed against Insight Discovery. Specifics on range or precision are not provided, but the conclusion is "substantially equivalent." |
  | Accuracy (Range of Motion) | "The accuracy of the ViMove was tested and compared to the accuracy of the Vicon and found to be substantially equivalent for measuring range of motion in the sagittal and coronal anatomical planes." |
  | Compliance to International Standards | Complied with:
• ISO 14971 (Risk Management)
• ISO 13485 (Quality Management)
• ISO 14155 (Clinical investigation, Good clinical practice - though no clinical data was submitted)
• IEC 60601-1 (Electrical Safety)
• IEC 60601-1-2 (EMC)
• ISO 15223 (Medical device symbols)
• ISO 10993-5 (In vitro cytotoxicity)
• ISO 10993-10 (Irritation and skin sensitization)
• 16 CFR 1500 (FHSA Regulations for Cytotoxicity, Sensitization and Primary Skin Irritation tests)
• IEC 62304 (Software life cycle processes) |
  | Mechanical Durability | Bench tested to withstand:
• Crush and shock (drop) tests for components (IEC 60601-1)
• DAP-M/E assembled with MD sensors: drop test from 1.5 meters onto hardwood floor with concrete base & crush force of 25kg.
• RFD: drop from 2m onto hardwood floor with concrete base without functional damage & crush force of 25kg. |

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" sample size for proving substantial equivalence in terms of performance metrics like accuracy. The evaluation was primarily comparision of the ViMove's features and its performance to existing predicate devices (Insight Discovery and Vicon).

• Clinical Data: "Not applicable." This indicates there was no clinical study conducted with human subjects specifically for this 510(k) submission to generate new performance data from a "test set."
• Data Provenance: The performance assessment was based on bench testing and comparison to existing predicate devices' known performance. There's no mention of country of origin for any human subject data, as none was used. The study is not prospective or retrospective in the clinical sense, as it's a device comparison and bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As no clinical data or "test set" involving human subjects was used to establish novel performance claims or ground truth in this submission, no experts were utilized for this purpose. The device's "accuracy" was compared to a predicate device (Vicon), implying the Vicon's output served as a reference or "ground truth" for that specific comparison, but the document doesn't detail how Vicon's "ground truth" itself was established in this context.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study was conducted or referenced. The device is a measurement tool, not an interpretive AI tool that would assist human readers in diagnosing cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The accuracy comparison described ("The accuracy of the ViMove was tested and compared to the accuracy of the Vicon...") suggests a standalone performance evaluation of the ViMove's ability to measure range of motion. It was compared directly to another device (Vicon) without human intervention in the measurement process itself, thus evaluating its "algorithm only" performance for that specific function.

7. Type of Ground Truth Used

• For the accuracy of range of motion, the ground truth was effectively the measurement provided by the Vicon device, which itself is a commercially available and presumably validated goniometer. The document states, "The accuracy of the ViMove was tested and compared to the accuracy of the Vicon..."
• For other performance characteristics, the "ground truth" was established by compliance with voluntary standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and bench testing criteria (e.g., drop test parameters, crush force).

8. Sample Size for the Training Set

Not applicable. The ViMove is a measurement device that employs sensors and software. The submission does not indicate the use of AI/machine learning requiring a "training set" in the context of its 510(k) summary. The "software life cycle processes" standard IEC 62304 is mentioned, but this refers to general software development practices, not necessarily machine learning model training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set for an AI/machine learning algorithm was referenced in this submission.

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