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Mini, Model EC12-01 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Mini, Model EC12-01 is not intended to be used as a therapy for any medical condition. None of the Mini programs are designed for injured or ailing muscles and their use on such muscles is contraindicated. Mini, Model EC12-01 is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation(EMS) through skin contact electrodes. Indications for use are as follows: Mini is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Mini is not intended to as a therapy for any medical condition. Please read the indications, precautions and warnings carefully to determine whether any of them apply to you. Mini stimulates action potentials in the motor nerves supplying muscle. Different patterns of muscle activity can be imposed on the target muscle, depending on the timing and intensity of the stimulation signal. Mini contains programs for exercise warm-up, muscle performance improvement and exercise recovery.

The Mini is a powered muscle stimulator for muscle conditioning. It is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatique resistance. Unlike the classified powered muscle stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes. The Mini is a 9 volt battery powered hand-held device, with detachable electrodes. The electrodes are placed over the muscles which are to be stimulated. The muscles are excited by electric pulses which are created by an electronic circuit. This circuit is software driven, to the user can adjust the stimulation. Mini is pre-programmed with 6 stimulation programs. Programs duration varies depending on the selected mode, which can be reduced by user inputs.

The provided document is a 510(k) Summary for the "Mini Model EC12-01" Powered Muscle Stimulator. It claims substantial equivalence to a predicate device, the Slendertone 561 (K071666). However, the document does not describe an acceptance criteria or explicitly detail a performance study proving the device meets specific performance criteria through empirical testing with human subjects or a defined dataset.

Instead, the submission focuses on demonstrating substantial equivalence to the predicate device by comparing technical specifications and intended use, and by showing compliance with relevant safety standards.

Here's a breakdown based on the information provided, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in terms of discrete acceptance criteria and corresponding reported performance metrics (e.g., accuracy, sensitivity, specificity) for device functionality related to muscle stimulation efficacy.

The document does include a table comparing the EC12-01 to the predicate device (MODEL561) across various parameters (Mode/Function, Duration, Intensity Range, Waveform, etc.). This table serves to demonstrate that the devices are technically similar, implying similar performance. The "Discussion" column in this table addresses potential differences and argues that they do not constitute safety or effectiveness differences, thereby serving a similar purpose to a performance claim.

Table of Technical Comparison (serving as indirect performance comparison):

The document also lists "Performance and Safety Testing" by referencing compliance with several IEC and ISO standards and an FDA guidance document. This implies that the device's performance aligns with the requirements of these standards.

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

No information provided. The document does not describe a test set, human subjects study, or clinical trial to assess the device's efficacy in improving muscle performance. The submission relies on claiming substantial equivalence to a predicate device.

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/information not provided as no test set requiring expert ground truth was described for efficacy.

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

This is not applicable/information not provided as no test set requiring adjudication was 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:

This is not applicable. The device is an electrical muscle stimulator, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in that context.

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

This is not applicable. The device is a physical muscle stimulator, not an algorithm. Its operation inherently involves human interaction (placing electrodes, selecting programs, adjusting intensity). The "software" mentioned drives the electrical pulses, it's not a standalone diagnostic or interpretive algorithm.

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

This is not applicable/information not provided as no study requiring such ground truth was described for the device's performance in improving muscle performance. The "ground truth" for the submission's argument is the predicate device's established safety and effectiveness.

8. The sample size for the training set:

Not applicable/information not provided. There is no mention of a "training set" in the context of device performance assessment. The "programming" of the CMOS chip is mentioned, but this refers to the internal software development rather than machine learning training.

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

Not applicable/information not provided. As there is no training set described for performance assessment, there is no mention of how ground truth would have been established for it.

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