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Everyway Incontinence Stimulation System is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Everyway Incontinence Stimulation System ( Stimulator models EM-2400 and EM-5300 with Vaginal Probe models PR-02A, PR-04A and PR-14A )

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "Everyway Incontinence Stimulation System." The document is a 510(k) clearance letter from the FDA, which primarily states that the device has been found substantially equivalent to predicate devices and outlines regulatory requirements. It does not include details about specific performance metrics or clinical study results.

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Everyway Incontinence Stimulation System is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

The Everyway Incontinence Stimulation System is a dual channel powered muscle stimulator intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

The EV-805I stimulator is basically an Everyway's existing K071951-510(K) cleared model for power muscle stimulator. To make it delivery the same stimulation output as that of chosen predicate device, we made some change in software so as to generate muscle stimulation current that is discharged through the PR-02A, PR-04A, PR-14A Life-Care Vaginal Probe on the vaginal skin for the treatment of urinary incontinence.

The device is operated in such a way that turn on the intensity control knob and adjust the intended intensity or turn off the device during operation through the same control knob. While device is turned on for operation, the related LCD icons then illuminate for indicating the device is in operation condition. User then follow the instruction for use to get appropriate stimulation treatment for urinary incontinence.

With the combination of the main device parts as above mentioned , the device can be used as recommended in manual for the treatment of urinary incontinence for over-the-counter (OTC) use as that of the chosen 510(K) predicate device.

The Everyway Incontinence Stimulation System is an electrical muscle stimulator intended for the rehabilitation of weak pelvic floor muscles to treat stress, urge, and mixed urinary incontinence in women and maintain urinary continence.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold for a performance metric in the way it might for a diagnostic device (e.g., sensitivity of X, specificity of Y). Instead, the study's goal was to demonstrate substantial equivalence to a predicate device. This is primarily achieved through comparing technical characteristics and demonstrating comparable safety and effectiveness.

The table below outlines the comparison of key parameters between the proposed device and its predicate:

Reported Device Performance:
The document states that a "Usability Study was conducted for the Everyway Incontinence Stimulation System to support the device design and labeling for over-the-counter use of the device." Specific performance metrics from this usability study (e.g., success rates, time to task completion, error rates) are not provided in this summary. The conclusion is that "verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."

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

The document mentions a "Usability Study" but does not specify the sample size used for the test set. It also does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

The document mentions a "Usability Study" but does not describe the establishment of a "ground truth" in the context of expert review for a diagnostic or classification task, as the device is a therapeutic stimulation system. Therefore, no information is provided on the number or qualifications of experts for ground truth establishment.

4. Adjudication Method for the Test Set:

Given that the study described is a "Usability Study" for a therapeutic device and not a diagnostic efficacy study involving expert review for ground truth, an adjudication method for a test set (like 2+1 or 3+1) is not applicable and therefore not mentioned.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on how human readers improve with AI vs. without AI assistance was not mentioned or performed. This type of study is typically relevant for diagnostic AI applications, not for an electrical stimulation system for incontinence.

6. Standalone (Algorithm Only) Performance:

The device is an electrical stimulation system, not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm's performance without human intervention is not applicable and not reported.

7. Type of Ground Truth Used:

For the usability study, the "ground truth" would likely relate to objective measures of user interaction, user feedback, and successful operation of the device according to instructions. However, the document does not explicitly state the type of ground truth used for the usability study. It is not pathology, expert consensus on images, or long-term outcomes data as might be seen for other device types.

8. Sample Size for the Training Set:

The document describes a "Usability Study," not an AI model. Therefore, there is no training set in the context of machine learning, and thus no sample size is applicable or reported for such a set.

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

As there is no training set for an AI model mentioned in the context of this device, the question of how its ground truth was established is not applicable.

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