(121 days)
Performance Plus Confidence Rings are devices that are placed around the base of the penis to help sustain an erection. An erection is achieved when the spongy corpora of the penis fills with arterial blood during sexual stimulation. In certain men, the penis may not become fully erect because the penile venous system drains too rapidly or leaks blood from the corpora. The rings operate by limiting venous return from the major superficial veins of the penis.
The E.I.D. system is an external erection device that induces penile rigidity though vacuum assisted vascular engorgement of the penis. Once erection is achieved, a Confidence ring is placed at the base of the penis to sustain the erection.
The Performance Plus Confidence rings are soft, pliable rings with a tab for removal. The E.I.D. system consists of a vacuum tumescence pump, a vacuum chamber with inserts, Confidence rings, lubricating gel, instructions for use, and a carrying case.
This document is a 510(k) premarket notification for "Performance Plus Confidence Rings" and the "Performance Plus Erection Inducer Device (E.I.D.)" for over-the-counter (OTC) use. As such, it primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested elements for a performance study are not applicable or not provided in this type of regulatory submission. The document explicitly states: "These devices are identical to the predicates, K891125(Confidence Rings) and K896060 (E.I.D) in materials, dimensions, performance, and intended use. The labeling is changed to provide the information needed for safe over the counter use of these devices." This indicates that extensive new performance studies were not conducted for the device itself, but rather the focus was on the labeling for OTC use.
Here's a breakdown based on the provided text, addressing each point as much as possible:
1. A table of acceptance criteria and the reported device performance
Not provided in this document.
The document asserts that the devices are "identical to the predicates... in materials, dimensions, performance, and intended use." This implies that the performance of the predicate devices implicitly meets whatever criteria were established for their original clearance, and the subject devices are expected to perform the same. No specific numerical performance metrics or acceptance criteria are listed for this 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided.
No new performance study data (test set) is presented in this document. The submission relies on the substantial equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not provided.
No new performance study requiring expert ground truth establishment is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided.
No new performance study requiring adjudication is presented.
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/Not provided.
This device is a physical medical device (penile constriction rings and vacuum pump), not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study and AI-related effect sizes are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided.
This is a physical medical device, not an algorithm. Standalone performance as an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided.
No new performance study data, and thus no new ground truth, is discussed. The "performance" is implicitly deemed equivalent to the predicate devices, which would have had their own evidentiary basis for clearance.
8. The sample size for the training set
Not applicable/Not provided.
No "training set" in the context of machine learning or an algorithm is relevant for this device.
9. How the ground truth for the training set was established
Not applicable/Not provided.
As above, no training set or ground truth in this context is relevant for this device.
§ 876.5020 External penile rigidity devices.
(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.