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BEMER therapy systems (BEMER Classic Set, BEMER Pro-Set) are indicated for:

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

BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER therapy is offered in two system options-Classic and Professional. Both systems consist of a B.BOX console, a set of BEMER signal applicators, power pack, B.SCAN indicator and accessories for attachment. The B.PAD and B.SPOT applicators have been cleared for use in this submission.

BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The resulting increase in local blood distribution can broadly benefit patients. The indications for use allow the application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.

Acceptance Criteria and Device Performance:

The provided document is a 510(k) summary for the BEMER Classic Set and BEMER Pro-Set. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining explicit acceptance criteria with specific performance metrics for the BEMER device itself.

However, the "Performance Testing" section states that "BEMER therapy systems are compliant with the following standards and have outputs that are within the same range as the predicate devices". This implies that the 'acceptance criteria' for the BEMER device's performance are that it meets these standards and operates within a comparable range to the predicate.

The "Technical and Performance Comparison" table (Table 12.1) details the comparison between the BEMER Therapy Systems (Subject Device) and the predicate device (Revitive IX, K143207) and a reference device (Neotonus MS-101 Magnetic Muscle Stimulator System, K973929).

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, direct acceptance criteria with specific numerical thresholds for increased blood circulation or improved muscle performance are not provided. Instead, the acceptance is based on demonstrating substantial equivalence by meeting regulatory standards and having comparable technical characteristics and functionality to the predicate device.

Study Information:

The document (510(k) summary) describes the basis for a Substantial Equivalence (SE) determination to a predicate device, rather than a de novo clinical trial with specific performance endpoints. The primary "study" proving the device meets the (implied) acceptance criteria is the comparative analysis to the predicate device and compliance with recognized standards.

Key points from the document regarding studies:

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

• The document mentions "clinical performance data" to support its safety and suitability for OTC use but does not provide details on the sample size of any specific clinical test set.
• It states that "safety and effectiveness must be proven via a comparative series of measurements" due to the different mode of action, but the details of these measurements (sample size, data provenance) are not included in this summary.
• The provenance of data for any comparative measurements or clinical studies is not explicitly stated (e.g., country of origin, retrospective or prospective).

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

• This information is not provided in the 510(k) summary. The document does not describe a process where experts established ground truth for a test set in the context of typical diagnostic device evaluation (e.g., imaging studies). The evaluation appears to be based on engineering principles, compliance with standards, and comparison of technical specifications and intended use.

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

• As there's no mention of a traditional "test set" and expert ground truth establishment for diagnostic performance, no adjudication method is described.

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 MRMC study was described. The BEMER device is a physical medicine device (a powered muscle stimulator), not an AI-powered diagnostic tool, so such a study would not be applicable.

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

• This concept is not applicable to this type of medical device (physical stimulator).

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

• The "ground truth" for the device's claims (temporarily increase local blood circulation, stimulate healthy muscles) is primarily established through scientific literature on electromagnetic stimulation, engineering principles, and comparison to the predicate device's established efficacy and safety.
• The document implies that "clinical performance data" was used, and the "Usability study" serves as "performance data" for safe and effective use by lay and professional users based on their knowledge and instructions. The ground truth for usability would be the users' ability to correctly and safely operate the device as observed during the usability study.

8. The sample size for the training set:

• There's no mention of a "training set" as this is not an AI/machine learning device. The design and development would follow traditional medical device engineering processes.

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

• This concept is not applicable as there is no "training set."

Summary of the "study" proving acceptance:

The primary "proof" relies on demonstrating that the BEMER Therapy Systems are substantially equivalent to legally marketed predicate devices. This involves:

• Comparison of Indications for Use: Showing identical intended uses for the BEMER device and the predicate.
• Comparison of Technological Characteristics: Analyzing features like mode of action, waveform, pulse repetition rate, output parameters, and identifying any differences. For differences, the document provides comments on whether these differences impact safety and effectiveness (e.g., "Minor difference, no impact on safety and effectiveness").
• Compliance with Recognized Standards: Declaration of conformity to numerous IEC standards (e.g., IEC 60601-1 for safety, IEC 60601-1-2 for EMC) and ISO standards (e.g., ISO 10993-1 for biocompatibility). These standards inherently contain their own acceptance criteria for safety and performance under various conditions.
• Usability Study: A usability study was explicitly conducted and followed FDA's human factors guidance to ensure that intended users can operate the device safely and effectively. The results confirmed its suitability for Over-The-Counter (OTC) use.
• Clinical Performance Data (mentioned but not detailed): The document generally states that "Clinical performance data demonstrate that BEMER therapy Systems are as safe as the predicate device and it is suitable for Over-The-Counter (OTC)." However, the specifics of these clinical studies (methodology, sample size, endpoints, results) are not elaborated in this summary. It's possible these details were provided in other parts of the 510(k) submission, but not in this public summary.

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