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1 Relaxation of muscle spasms;
2 Prevention or retardation of disuse atrophy;
3 Increasing local blood circulation;
4 Muscle re-education;
5 post-surgical stimulation of calf muscles to prevent venous thrombosis; and
6 Maintaining or increasing range of motion.

The SRT II Muscle Stimulator is comprised of the following main components:

A system console including software and control electronics; A control and display panel: Device accessories including Muscle Stimulator electrodes and cables.

The SRT II Device is a 4 mode, 10-channel unit for muscle stimulation housed in a portable case. The microprocessor controlled SRT II Device provides Muscle Stimulator alternating current with enhanced reliability and user friendly interface.

The user friendly interface and its display provides operator information about operation mode and signal intensities.

The provided text describes a 510(k) premarket notification for a medical device called the "SRT II® Muscle Stimulator." This submission primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Harmonic Emissions IEC 61000-3-2" and "Voltage Fluctuations/Flicker Emissions IEC 61000-3-3" as N/A, meaning they were either not applicable or not tested for this device's conformity.

2. Sample Size Used for the Test Set and Data Provenance

The submission states "Non-Clinical Tests Submitted" and details compliance with various IEC and CISPR standards for electromagnetic compatibility. These are bench tests and thus do not involve human subjects or clinical data in the traditional sense of a "test set." Therefore, there is no sample size for a test set and no data provenance (such as country of origin, retrospective/prospective). The tests were conducted in a laboratory setting to verify technical specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. As this involved non-clinical bench testing for electromagnetic compatibility, there was no need for experts to establish ground truth on clinical data. The "ground truth" for these tests is defined by the technical specifications and standards (e.g., CISPR 11, IEC 61000-4-x).

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers or experts evaluating patient data. Since only non-clinical bench testing was performed, no adjudication method was employed.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states "Clinical Tests Submitted: None." Therefore, no MRMC comparative effectiveness study was done, and there is no reported effect size regarding human readers improving with or without AI assistance. This device is an electrical muscle stimulator, not an AI-driven diagnostic or therapeutic tool for which such a study would be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. The SRT II Muscle Stimulator is a hardware device with embedded software for control. It is not an algorithm that performs a standalone diagnostic or therapeutic function without human intervention in the way an AI-driven image analysis tool would. Its performance is evaluated through its physical and electrical characteristics as per the non-clinical tests.

7. Type of Ground Truth Used

The "ground truth" for this submission is established by technical standards and specifications for electromagnetic compatibility and safety (e.g., CISPR 11, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4). The device's performance is compared against these predefined acceptable levels.

8. Sample Size for the Training Set

Not Applicable. This submission describes a hardware device, not a machine learning or AI model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As no training set was involved, no ground truth was established for it.

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