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Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion
  Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.

A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.

The provided document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way typically seen for novel devices.

Here's an analysis based on the provided text, addressing your questions where possible:

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

• Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is Substantial Equivalence to the predicate device (HOME CARE Powered Muscle Stimulator, K023000). The specific performance parameters for substantial equivalence are implicitly linked to the predicate device's established safety and effectiveness.
• Reported Device Performance: The document states that the SAN SHIH Powered Muscle Stimulator, 202 is "as safe and effective as, and the function in a manner equivalent to the predicate device."

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

• No clinical test set was used for performance evaluation. The submission explicitly states "Clinical Tests Submitted: None."
• The data provenance for safety and effectiveness is largely based on non-clinical tests (electrical safety, electromagnetic compatibility, specific requirements for nerve and muscle stimulators) rather than studies on human subjects. The device originates from Taiwan, ROC.

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)

• Not applicable. No clinical test set was used, and thus no expert-established ground truth on patient data was required for this particular submission type.

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

• Not applicable. No clinical test set was used.

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 device is a powered muscle stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed or required.

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

• This device is a standalone therapeutic device (a physical stimulator), not an algorithm. Its performance is inherent in its electrical output and mechanical function, which was assessed through non-clinical testing.

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

• For the non-clinical tests, the "ground truth" was compliance with applicable standards for medical device electrical safety, electromagnetic compatibility, and the particular requirements for safety of nerve and muscle stimulators. These standards serve as the benchmark for safety performance.
• For effectiveness, the ground truth is the established effectiveness profile of the predicate device. The claim is that the new device functions in a "similar manner" for the same "indications for use."

8. The sample size for the training set

• Not applicable. This device is a hardware product, not a machine learning algorithm. Therefore, there is no training set in the AI sense.

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

• Not applicable. As above, there is no training set.

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