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TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

The device of the model FM-B2403A is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg. 4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations.

Here's a breakdown of the acceptance criteria and the study information based on the provided FDA 510(k) summary for the TENS & EMS Device (Model: FM-B2403A):

Please note: This document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device, not a typical clinical trial report for an AI-powered diagnostic/treatment device. Therefore, many of the typical questions regarding AI device performance studies (like test set provenance, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or explicitly stated in this type of submission. The "acceptance criteria" here refer to regulatory standards and comparative technical specifications, not predictive performance metrics.

Acceptance Criteria and Reported Device Performance

Note 1 (on Table 1): The weight, dimensions, and appearance of the proposed device FM-B2403A have small differences from the predicate device K202866, but these differences are insignificant and won't raise any new risk of safety and effectiveness.
Note 1 (on Table 3): Differences in maximum output voltage, maximum output current, pulse duration, and frequency have passed IEC 60601-2-10 test codes and won't raise new risks.
Note 2 (on Table 3): Differences in net charge, maximum phase charge, maximum current density, maximum power density, bursts per second, burst duration, and duty cycle do not exceed safety limits and have passed IEC 60601-2-10 tests. Maximum average power density <0.25Watts/cm². Therefore, these differences won't raise any new safety and effectiveness risk.

Study Information (Based on a 510(k) Submission for a TENS/EMS Device):

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

   • Test set size: Not applicable. This submission relies on non-clinical (bench) testing against recognized standards and technical comparisons to a predicate device, not clinical data from human subjects for performance evaluation.
   • Data provenance: The performance data comes from non-clinical laboratory studies and safety testing, performed in a controlled environment as part of the device manufacturing and regulatory compliance process. The country of origin for the tests conducted is not explicitly stated but would typically be part of the manufacturer's internal quality management system and testing facilities (Shenzhen, China, in this case). The data is by nature prospective with respect to the regulatory submission, meaning the tests were conducted specifically to support this application.

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

   • Not applicable. "Ground truth" in the AI/diagnostic sense is not relevant here. The "ground truth" for this device's performance is established by meeting electrical safety standards (e.g., IEC 60601 series) and comparing technical specifications to a previously cleared device. The compliance is assessed by engineers and technicians trained in these standards.

3. Adjudication method for the test set:

   • Not applicable. There's no human interpretation or adjudication of outputs in the way you might find in an imaging AI study. The "adjudication" is through physical and electrical measurements and subsequent comparison to predefined pass/fail criteria from international safety standards and the predicate device's specifications.

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. This device is a direct-to-consumer TENS & EMS device, not an AI-assisted diagnostic or therapeutic tool with a human-in-the-loop component.

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

   • Not applicable. Similar to point 4, this is not an AI algorithm. The device's performance is evaluated based on its physical, electrical, and functional characteristics as a medical device.

6. The type of ground truth used:

   • The "ground truth" for this submission are the international electrical safety and performance standards (e.g., IEC 60601 series, ISO 10993 for biocompatibility) and the technical specifications of a legally marketed predicate device (K202866). The device is deemed safe and effective if it meets these established standards and is substantially equivalent in technology and intended use.

7. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device requiring a training set.

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

   • Not applicable. There is no training set.

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