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The Biomove 5000 is indicated for:

1. Stroke Rehabilitation by Muscle Re-education
2. Prevention of retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Maintaining or increasing range of motion

The Biomove 5000 is a powered EMG triggered neuromuscular electrical stimulator device used as a training system for rehabilitation of paralyzed muscles, mainly after stroke. The following accessories are supplied with the system: Patient Cable, re-usable electrodes (Biotrodes).

The provided 510(k) summary for the Biomove 5000 System does not contain a study that proves the device meets specific acceptance criteria based on performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, the Biomove 3000 (K042650), in terms of intended use, indications for use, technological characteristics, performance, and user interface.

Therefore, many of the requested sections below cannot be populated as the provided document does not describe a clinical performance study with acceptance criteria.

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary states that the Biomove 5000:

• "complies with U.S. Federal Performance Standard as set forth in 21 CFR 898 for electrode lead wires and Patient Cables."
• "complies with the following recognized standards: IEC 60601-1(1988), including amendments #1(1991), #2(1995); IEC 60601-2-10 (1987)."
• "complies with the Guidance Document for Powered Muscle Stimulator 510(k)s; Final (1999)."

These are regulatory and design compliance statements, not direct performance acceptance criteria from a clinical study.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. No clinical test set data is provided.
• Data Provenance: Not applicable. No clinical study data is provided.

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

• Not applicable. No clinical study data is provided, and therefore no ground truth establishment by experts for a test set is mentioned.

4. Adjudication method for the test set:

• Not applicable. No clinical study data is provided.

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:

• Not applicable. This device is a muscle stimulator, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or is relevant.

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

• Not applicable. This is a medical device (muscle stimulator), not an algorithm or AI system. Its performance is inherent to its physical and electrical characteristics.

7. The type of ground truth used:

• Not applicable. As no clinical performance study demonstrating the device's efficacy against specific clinical outcomes is presented, there is no mention of a "ground truth" (e.g., pathology, extended outcomes) being used for validation. The submission relies on substantial equivalence to a legally marketed predicate.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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