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• To temporarily increase local blood circulation in healthy leg muscles
• To stimulate healthy muscles in order to improve and facilitate muscle performance

BEMER therapy system Evo is a noninvasive physical medicine device that can be used as a supportive therapy to increase local blood circulation.

BEMER Therapy System Evo improves local blood distribution via electromagnetic stimulatory principles. The indications for use allow application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.

The device is noninvasive, fully reusable (no disposable components such as electrodes), and has configurations allowing both patient/home and professional/office use.

This submission is for the redesigned BEMER Therapy System Evo model including all previous applicators plus a new applicator, B.BED Evo.

The device contains firmware that controls the user interface. It also contains the pulse generator, battery charger, audio and pushbutton controller.

This document is a 510(k) Premarket Notification from the FDA regarding the BEMER Therapy System Evo. It addresses the substantial equivalence of the BEMER Therapy System Evo to previously cleared predicate devices (K151834 and K210174).

The document does not describe an AI/ML-driven device or study involving human readers, AI assistance, or expert adjudication for ground truth establishment. Instead, it focuses on the equivalence of a physical medical device (a powered muscle stimulator) based on its technological characteristics, intended use, and non-clinical performance testing.

Therefore, I cannot extract the information required by your prompts (acceptance criteria for AI/ML, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI, etc.) because these concepts are not relevant to the described device and its regulatory submission.

The document details performance testing for physical device characteristics rather than algorithm performance on data. The "performance testing" mentioned refers to measurements of:

• BEMER signal waveform current output (AC RMS in mA) generated from the console.
• Magnetic flux output (uT) from the applicators at all signal intensity input levels.

These are engineering performance specifications for a physical device, not a study evaluating an AI model with human reading.

In summary, the provided text does not contain the information needed to answer your questions as it pertains to a physical medical device clearance, not an AI/ML device.

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