(112 days)
The ErecAid device is used to assist in creating and maintaining an erection suitable for sexual intercourse. These devices are intended for the treatment or management of erectile dysfunction/impotence.
ErecAid® System-OTC and StayErec® System Tension Rings-OTC
These devices are intended for the treatment or management of erectile dysfunction/impotence.
The Imagyn Medical Technologies, Inc. ErecAid System Classic vacuum erection system ("ErecAid") consists of a vacuum pump, tension rings, insert ring, clear plastic cylinder, and a tube of personal lubricant. The StayErec Tension Ring consists of a ring of the same material, and used in the same manner as the predicate device.
The provided text describes a 510(k) submission for the ErecAid™ Vacuum Erection and StayErec® Tension Ring Devices. This is largely a pre-market notification with a focus on demonstrating substantial equivalence to previously approved devices, rather than a clinical study evaluating novel performance criteria.
Therefore, many of the requested elements for describing an acceptance criteria study (such as sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or explicitly mentioned in this document. The document relies on equivalence to known predicate devices rather than new performance data against a specific set of acceptance criteria.
Here's a breakdown of the available information based on your request, with an emphasis on what is present and what is not:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of acceptance criteria and specific performance metrics for the ErecAid and StayErec devices. The primary "acceptance criterion" being met is substantial equivalence to predicate devices. The document implies that the device performs equivalently to the predicate devices because it uses the "same vacuum method and technological characteristics" and "uses the same components and materials."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The ErecAid and StayErec devices are "substantially equivalent" to predicate devices (ErecAid System Classic, ErecAid System Esteem Battery, StayErec Tension Rings) based on identical intended use, same vacuum method and technological characteristics, and same components and materials. |
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. This document does not describe a clinical study with a test set. The determination of substantial equivalence is based on a comparison of technical characteristics and intended use with existing 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. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there's no clinical test set.
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 a mechanical medical device, not an AI or imaging diagnostic tool, so an MRMC study is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is the established performance and safety of the predicate devices. The new device is deemed acceptable because it is sufficiently similar to these already approved devices.
8. The sample size for the training set
Not applicable. No training set is involved as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.