(121 days)
The Biomove 3000 is indicated for:
- Stroke Rehabilitation by Muscle Re-education
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
The Biomove 3000 is a portable, battery powered EMG triggered neuromuscular electrical stimulator device used as a training system for rehabilitation of paralyzed muscles, mainly after stroke. The controls of the device are simple to operate. It has only two main control knobs: one to set the gain of the EMG amplifier (sensitivity for picking up the residual electrical muscle signal) and one to set the level for the stimulation impulse to the muscles to be re-educated. The following parts are supplied with the system: 3-lead Patient Cable, re-usable electrodes (Biotrodes) and a belt for fastening the device to the body of the user. A 5-lead Patient Cable is optional.
The provided text describes the Biomove 3000 System, a neuromuscular electrical stimulator. However, it does not include a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size of human improvement.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices cleared by the FDA. This regulatory pathway means that the device is considered safe and effective because it is similar to devices already on the market, rather than requiring new clinical performance studies with acceptance criteria and statistical analysis.
Here's a breakdown based on the information provided and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Performance Metrics) | Reported Device Performance |
|---|---|
| Specific performance criteria (e.g., accuracy, sensitivity, effect size on human readers) are not provided in this document. | The document states "Safety and performance testing" and "Comparative Testing" were performed, but does not detail the nature of these tests, specific acceptance criteria, or quantitative performance results for the device itself. Instead, it relies on substantial equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. The document does not describe a clinical study with a "test set" in the context of independent verification of performance metrics. The submission is based on substantial equivalence, implying that no new primary clinical performance data was required to be submitted for evaluation beyond what's inherent in the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. No new clinical study requiring ground truth establishment by experts is described for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No new clinical study requiring adjudication is described for this submission.
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. This device is a muscle stimulator, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant to this device and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical muscle stimulator, not an algorithm, so the concept of "standalone performance" in the context of AI is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided. As no new performance study requiring ground truth is described, this is not relevant. The basis of approval is substantial equivalence to legally marketed predicate devices, implying their safety and effectiveness have already been established.
8. The sample size for the training set
- Not Applicable / Not Provided. This device does not use machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As no training set is relevant, no ground truth establishment for it is described.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The provided document does not describe a new clinical study with specific acceptance criteria and detailed performance results for the Biomove 3000 System. Instead, the device's clearance is based on substantial equivalence to two predicate devices: the NeuroMove NM900 (K012885) and the AutoMove, Model AM800 (K032955).
The claim of equivalence is supported by:
- The Biomove 3000's intended use and indications for use are identical to those previously cleared for the predicate devices.
- The technical characteristics of the Biomove 3000 are similar to those of the predicate devices.
- "Safety and performance testing" and "Comparative Testing" were conducted, but the details of these tests, specific methodologies, sample sizes, or quantitative results are not provided in this summary. The focus is on demonstrating that these tests confirm similarity to the predicates, rather than proving performance against novel, pre-defined acceptance criteria.
- Compliance with recognized electrical safety and medical device standards (IEC 60601-1, IEC 60601-2-10) and FDA guidance documents for powered muscle stimulators.
The FDA's decision to clear the device (K042650) confirms that the agency found the Biomove 3000 System to be substantially equivalent to its predicate devices, meaning it raises no new safety and/or effectiveness issues. Therefore, the "study" proving the device meets acceptance criteria is, in this context, the demonstration of its substantial equivalence to already cleared devices based on comparison of intended use, technological characteristics, safety data, and general performance observations, rather than a new, detailed clinical trial with specific performance endpoints.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).