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As a powered muscle stimulator the Biological Feedback and Stimulation System is indicated for thefollowing conditions:

• Relaxation of muscle spasm
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion

As a biofeedback device the Biological Feedback and Stimulation Systemis indicated for thefollowing conditions:

• Biofeedback, relaxationand muscle re-education purposes
  As a nonimplanted electrical continence device the Biological Feedback and Stimulation Systemisindicated for the following conditions:

· Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detrusor muscles through reflexive mechanisms and strengthening of pelvic floor muscles.

● Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles.

This Biological Feedback and Stimulation System is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.

The provided text describes a 510(k) premarket notification for a "Biological Feedback and Stimulation System." It lists the device's indications for use, its comparison to a predicate device, and performance data to support substantial equivalence. However, it does not specify acceptance criteria, nor does it conduct any clinical studies with human participants for determining the device's performance against such criteria. The "Performance Data" section focuses entirely on non-clinical testing and compliance with recognized standards.

Therefore, many of the requested details cannot be extracted from the given document as they pertain to clinical performance studies, which are not detailed here.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not specify "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a study involving the device's efficacy or diagnostic capability. The "performance data" mentioned is entirely non-clinical and refers to compliance with safety, electromagnetic compatibility, and specific medical electrical equipment standards.

2. Sample size used for the test set and the data provenance

No test set involving human subjects or patient data is described. The "performance data" refers to engineering and laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no test set requiring expert ground truth is described.

4. Adjudication method for the test set

Not applicable, as no test set requiring adjudication is 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

Not applicable. The device is a "Biological Feedback and Stimulation System," a powered muscle stimulator, biofeedback device, and non-implanted electrical continence device. It does not appear to be an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

Not applicable. The device is a physical medical device, not an algorithm, and the performance data described is non-clinical verification of its design specifications and compliance with standards.

7. The type of ground truth used

Not applicable, as no clinical performance study requiring ground truth is described. The "performance data" listed relates to engineering specifications and compliance with voluntary standards.

8. The sample size for the training set

Not applicable, as no machine learning/AI model requiring a training set is described. The device includes "Software verification and validation test," but this refers to the software embedded within the medical device, not a training set for an AI algorithm.

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

Not applicable, as there is no training set for an AI algorithm mentioned.

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