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The SM9065 Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.

• The big belt is intended for use on the muscles in abdomen.
• The small belt is intended for use on the muscles in arms and thighs areas.
  Contraindicated use on injured or otherwise impaired muscles.
  Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

SM9065 Fitness Belt is a two channels battery operated muscle stimulation system to achieve the purpose of exercise and relaxation. It is comprised of a main device for signal generation, four belts for fixation, and series electrodes.
The big belt is intended for use on muscles in abdomen. The two small belts are intended for use on muscles in arms and thigh areas.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level and frequency level can be adjusted by user.

This document is a 510(k) summary for the SM9065 Fitness Belt, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to already marketed predicate devices rather than presenting a standalone study with acceptance criteria in the typical sense for clinical performance.

Here's a breakdown of the requested information based on the provided text, recognizing the nature of a 510(k) submission for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (a powered muscle stimulator for muscle toning), direct clinical acceptance criteria like sensitivity/specificity are not presented. Instead, the "acceptance criteria" are compliance with established electrical safety, EMC, and biocompatibility standards, and demonstrating waveform parameters are within acceptable ranges and comparable to predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document describes bench testing against standards, not a clinical trial with a "test set" of patient data. Therefore, the concept of sample size and data provenance in a clinical context does not apply here. The "test set" refers to the device itself being tested according to engineering and safety standards. The document does not specify the number of units tested, but standard compliance typically involves testing representative samples. Data provenance is not applicable for this type of testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable. For a 510(k) submission regarding a powered muscle stimulator, and specifically for bench testing against established engineering and safety standards, "ground truth" is defined by the requirements of those standards (e.g., a certain voltage must be output, a certain current limit must not be exceeded). The tests are performed by qualified engineers or technicians in testing facilities, but the "ground truth" itself is the standard's specification, not expert consensus on medical images or clinical outcomes.

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

Not applicable. This type of device does not involve expert adjudication as one would find in studies assessing diagnostic accuracy where ground truth is challenging to establish.

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 is a powered muscle stimulator, not an AI diagnostic or assistance device. No MRMC study was mentioned or would be relevant for this type of device.

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

This refers to the performance of the device's hardware and software alone as an electrical stimulator. The document states that bench tests were conducted to verify that the subject device meets all design specifications. These include:

• Electrical safety tests (IEC 60601-1, IEC 60601-2-10)
• Electromagnetic compatibility tests (IEC 60601-1-2)
• Software verification and validation tests
• Waveform tests (verifying output parameters according to FDA guidance)
• Biocompatibility tests (ISO 10993-5, ISO 10993-10)

These tests evaluate the device's inherent performance characteristics, without human interaction other than operating the device for the purpose of testing.

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

The "ground truth" for this submission is adherence to recognized electrical safety, biocompatibility, and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993 series, and FDA guidance documents for powered muscle stimulators). The device's measured parameters (voltage, current, frequency, etc.) are compared against the limits and specifications defined by these standards and guidance.

8. The sample size for the training set

Not applicable. This device is not an algorithm trained on a dataset. It's a hardware device evaluated against engineering standards.

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

Not applicable. There is no training set for this device.

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