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External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

(EMS) Electrical Neuromuscular Stimulator For Muscle Reeducation - Class II Model BMLS02-5

The provided text is a 510(k) premarket notification approval letter for an Electrical Neuromuscular Stimulator (EMS) device (Model BMLS02-5). This document does not describe a study involving acceptance criteria and device performance in the context of an AI/ML algorithm or diagnostic accuracy study.

Instead, the letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. The "Indications for Use" section (Attachment VIII) describes the therapeutic purposes of the device, which are typical for an EMS (e.g., muscle reeducation, relaxation of muscle spasm, prevention of disuse atrophy).

Therefore, I cannot provide the requested information as it is not present in the given document. The document describes a regulatory approval process based on substantial equivalence, not a clinical study assessing predefined acceptance criteria against device performance metrics like sensitivity, specificity, or AUC using a test set with expert ground truth.

To reiterate, the provided text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information about sample sizes for a test set, data provenance, or training set size.
3. Details about experts establishing ground truth or adjudication methods.
4. Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.
5. The type of ground truth used in the context of a diagnostic study.

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