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Everyway OTC EMS is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. Everyway OTC EMS may therefore be considered a technique of muscle training.

The Everyway OTC EMS, model EV-805 is a dual channel powered muscle stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance by applying an electrical current to electrodes, which are attached on the user's skin.

The device measures 101mm(H)x 68mm(W)x21.5mm(D). Its outer housing is made of injection molded thermoplastic resin with the output contact probes consist of chrome-plated spheres. The device is powered by a 9-Volt battery to generate output pulses that is discharged through the two adhesive electrode placed on the patient's skin for treatment and muscle training.

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. User then follow the instruction for use to get appropriate stimulation treatment and/or training on the healthy muscles.

This document describes the 510(k) premarket notification for the Everyway OTC EMS, Model EV-805, a powered muscle stimulator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (K102926: Gemore Muscle Conditioner/Model GM320PE).

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria for this device, as presented in the document, is demonstrating substantial equivalence to a predicate device. This is achieved through a comparison of key parameters, with "Substantial Equivalence (SE)" being the reported performance. The table below summarizes the comparison:

*SE = Substantially equivalent

The document states that "through the detailed calculation comparison of stimulation output energy for each operation mode (in particular the output current density and power density), we found the output level in each operation mode for our OTC EMS, Model EV-805 and predicate device are very close and within the acceptable range. So we believe the difference in detailed output parameters does not affect the determination of substantial equivalence."

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

The presented document does not describe a test set with a sample size in the context of clinical performance evaluation for this device. The submission relies entirely on non-clinical tests (compliance to standards) and a comparison to a predicate device to establish substantial equivalence.

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

As there was no clinical performance test set, there were no experts used to establish ground truth in this context. The determination of substantial equivalence is based on engineering and performance criteria compared to the predicate through non-clinical testing.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission is focused on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications, not on evaluating the improvement of human readers with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

N/A. This device is a powered muscle stimulator, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. Its performance is evaluated based on its electrical output characteristics and compliance with safety standards.

7. Type of Ground Truth Used

The "ground truth" implicitly used for this submission is the established safety and effectiveness of the legally marketed predicate device (K102926), and compliance with recognized national and international safety standards. The assessment is that the new device's technical specifications and non-clinical test results are comparable or fall within acceptable limits of the predicate.

8. Sample Size for the Training Set

The document does not mention a training set. This type of device (powered muscle stimulator) typically does not involve machine learning algorithms or AI that would require a training set.

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

Not applicable, as there was no training set.

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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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