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EV-807P Electrical Muscle Stimulator is an electrically powered muscle stimulator intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for:

• Relaxing muscle spasms -
• Increasing local blood circulation. ﻤ
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. -
• Muscle re-education. -
• Maintaining or increasing range of motion -
• Preventing or retarding disuse atrophy -

The Special 510(k) premarket notification describes a modification to Everyway's currently legally marketed EV-807 Digital Electrical Stimulator. The proposed modifications including linearly increase of output current, more programs for the physical therapist to create different parameters, more options of output type between 2 channels and device case. The modifications of the predicate device make the stimulation even more comfortable and effective.

The provided document is a 510(k) premarket notification for a Neuromuscular Electrical Stimulator (EV-807P). The submission claims substantial equivalence to a predicate device (Digital EMS, model EV-807 from Everyway Medical Instruments Co., Ltd., 510k# K020750) rather than presenting a de novo device with acceptance criteria and a study proving performance against those criteria.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the submission strategy relies on demonstrating that the modified device (EV-807P) is "safe and effective as the predicate device" through a comparison of technological characteristics.

Here's how the document addresses the concept of "performance" in the context of substantial equivalence:

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

• Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity). The concept of "acceptance" here relates to demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: The document states that "Performance" of the EV-807P is "Similar" to the predicate device (K020750) in the "Summary comparing technological characteristics with other predicate device" table. No specific performance data or quantitative metrics are provided.

The following points (2-9) are not applicable as no performance study was conducted or reported in this 510(k) submission.

2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 an electrical stimulator, not an AI-assisted diagnostic tool).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of the document's argument for safety and effectiveness:

The submission focuses entirely on demonstrating "substantial equivalence" to a previously cleared device (K020750). The modifications to the device are described as "linearly increase of output current, more programs for the physical therapist to create different parameters, more options of output type between 2 channels and device case." The submitter argues these modifications make the stimulation "even more comfortable and effective" but provides no new data or studies to support this claim or any specific performance metrics. Instead, it relies on the predicate device's existing safety and effectiveness determination.

The FDA's letter concurs with the substantial equivalence determination, allowing the device to be marketed based on its equivalence to the predicate, rather than on new performance criteria and studies for the modified device.

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