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Viberect® Penile Vibratory Stimulation Device is a hand held medical device to provoke erections for men who experience erectile dysfunction.

The Viberect® device is a hand held medical device intended for use by the person at home for the purpose of stimulating the nerves of the penis for the purpose of activating several nerve reflexes which are responsible for initiation of penile erection and rigidity. This device is unique in that it has two gentle vibrating motors that allow simultaneous vibratory stimulation of both the upper and lower surfaces of the penis. As each side of the male penis is supplied by different nerves, simultaneous stimulation of the upper and lower surfaces increases sexual response.

The device is held by one hand easily, like holding a hair straightener. The penis is placed between the vibrating 'soft pads'. As pressure is increased to the device, it is automatically activated. The device can be deactivated by releasing the hand pressure which immediately shuts off the vibrating 'soft pads'. The touch pad on the Viberect provides further control by the user whereby the user can increase and decrease the frequency of vibration according to comfort and response. Finally, there are individual modes for the vibratory movement of the upper housing only, lower housing only, and both. The device is powered by rechargeable batteries. Vibratory stimulation for approximately 3-10 minutes is recommended.

The provided text describes the Viberect Penile Vibratory Stimulation Device and its 510(k) submission for over-the-counter (OTC) use. Let's break down the information to address your specific questions about acceptance criteria and the study that proves the device meets them.

Overview of the Device:
The Viberect® Penile Vibratory Stimulation Device is a hand-held medical device designed to stimulate nerves of the penis to provoke erections in men experiencing erectile dysfunction. It features two vibrating motors for simultaneous stimulation of both upper and lower penile surfaces. It is powered by rechargeable batteries and allows users to adjust vibration frequency via a touchpad.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the performance of the device in terms of clinical efficacy metrics (e.g., success rate of provoking erections). Instead, the acceptance criteria are generally implied through the non-clinical performance data and the demonstration of substantial equivalence to a predicate device.

The "acceptance criteria" primarily revolve around the device meeting established performance standards for safety (biocompatibility, electrical safety, EMC), mechanical integrity (shipping, drop, cleaning), and usability for OTC use. Clinical efficacy is largely inferred from the predicate device's established performance and the proposed device having identical technological characteristics and a reduced (or identical, for the remaining part) indication for use.

Here's a table based on the non-clinical performance data presented for the proposed device:

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

The document explicitly states that no clinical testing was required or performed to support the medical device for its primary indication (provoking erections for men with erectile dysfunction) because the indications for use are considered equivalent to the predicate device. Therefore, there is no sample size for a clinical test set for this specific aspect.

However, Usability testing was performed. The document states:

• "Usability testing was performed and determined to be acceptable to support OTC indications for use."
• "Usability study performed (per discussion with the FDA); refer to Section 18 and Exhibit 18-D and 18-E for Usability Protocol and Report."

Unfortunately, the provided excerpt does not include the sample size used for the usability test set or the data provenance (e.g., country of origin, retrospective/prospective) for that usability study.

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

Since no clinical efficacy study was conducted for the device's primary function, there was no test set for clinical performance requiring experts to establish ground truth.

For the usability study, the document does not specify the number or qualifications of experts involved in establishing ground truth (e.g., for evaluating usability issues).

4. Adjudication Method for the Test Set

As no clinical efficacy test set was used, there was no adjudication method described for clinical performance.

For the usability study, the document does not specify any adjudication method 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

No MRMC comparative effectiveness study was done. This device is a directly applied therapeutic vibratory stimulation device, not an AI-assisted diagnostic or interpretative system that would involve "human readers" or "AI assistance" in the sense of interpreting images or other data.

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

This question is not applicable to the Viberect device. It is a physical medical device for direct therapeutic application, not an algorithm or software. Its performance inherently involves human interaction (the user applying the device).

7. The Type of Ground Truth Used

• For clinical efficacy: The "ground truth" for the device's ability to provoke erections is implicitly based on the established safety and efficacy of the predicate device (Viberect, K110566), which has been on the market for several years. The current submission's device has identical technological characteristics and a similar indication for use.
• For non-clinical performance (biocompatibility, electrical safety, etc.): The ground truth is adherence to established national and international standards (e.g., ISO 10993-1, IEC 60601-1, IEC 60601-1-2).
• For usability: The ground truth would have been established through methodologies aligned with usability engineering processes (e.g., user performance, satisfaction, error rates), as determined in the usability study mentioned. The specifics are not provided in this excerpt.

8. The Sample Size for the Training Set

This question is not applicable. The Viberect device is not an AI/ML algorithm that requires a "training set" in the computational sense. It is a physical medical device.

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

This question is not applicable, as there is no "training set" for this type of device.

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