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The Everyway Incontinence Stimulation Electrode, model PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A for Life-Care Vaginal Probe & PR-06/06A, PR-12A, PR-13/13A for Life-Care Anal Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

The Life-Care Vaginal Probe models PR-02/02A, PR-03/03A, PR-04/04A, PR-10A, PR-11A, PR-14A are the light weight cylinder consisting of two or three independent conductive rings or plates that are paired and isolated, physically and electrically. The cylinder is shaped with a waist and handle for comfort positioning in vaginal canal for incontinent treatment as above mentioned and easy for removing after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing for reuse according to the validated cleaning method as recommended in user manual.

The Life-Care Anal Probe models PR-06/06A, PR-12A, PR-13/13A are the light weight cylinder consisting of two or three independent conductive rings that are paired and isolated, physically and electrically. The cylinder is shaped with a waist and handle for comfort positioning in rectal canal for incontinent treatment as above mentioned and easy for removing after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing for reuse according to the validated cleaning method.

To fit with different type of device connection, the lead wire of device was provided with two different type of wire connection terminals, the standard female plug terminal and pigtail terminal. For the model with pigtail connection terminal, the letter "A" in the last of model name (e.g. PR-02A ) to separate them from the model with standard female plug terminal.

The provided text describes a 510(k) premarket notification for Everyway Incontinence Stimulation Electrodes, comparing them to predicate devices. The submission focuses on demonstrating substantial equivalence rather than presenting an independent performance study with acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth establishment are not applicable or not provided in this document. The submission argues for equivalence based on similar intended use and technological characteristics, supported by non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific performance acceptance criteria for the Everyway Incontinence Stimulation Electrode. Instead, it relies on demonstrating substantial equivalence to predicate devices (Hollister Vaginal Stimulation/EMG Probe-Tampon K971541 and Anal Stimulation/EMG Probe-w/Stop K990456).

The table provided is a comparison of characteristics between the new device and the predicate devices, not acceptance criteria for a new performance study. The key assertion is that the "new device could maintain the same safety and effectiveness as that of cleared device."

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

• Sample Size: Not applicable. No clinical test or specific test set with patient data was conducted or described for evaluating the device's performance against specific acceptance criteria.
• Data Provenance: Not applicable. No clinical data provided.

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

Not applicable. No ground truth was established from expert consensus for a test set, as no clinical performance study was performed.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication 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 an incontinence stimulation electrode, not an AI-assisted diagnostic or therapeutic device requiring human reader interpretation or MRMC studies.

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

Not applicable. This device is a physical medical instrument, not an algorithm, so standalone performance in that context is not relevant.

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

Not applicable. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices through comparison of technical characteristics and non-clinical tests (device performance, cleaning validation, biocompatibility), not on direct clinical outcomes or expert-derived ground truth.

8. The sample size for the training set

Not applicable. No training set was used as this is not an AI/machine learning device.

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

Not applicable. No training set was used.

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