(225 days)
Erco-Ribbon ™ is used to maintain penile rigidity in men with erectile dysfunction. It restricts blood outflow from the penis after the patient has obtained an erection (either with the aid of a vacuum pump, or naturally).
Men with firm but short lasting erection may use constricting device separately.
If a man is impotent to a degree that he is unable to achieve a natural erection, a vacuum constriction system may help him to overcome this dysfunction.
Erco-Ribbon ™ can be used for patients with following conditions:
- a) separately:
premature ejaculation,
firm but short lasting erection.
b) as a part of a vacuum constriction system:
Diabetes
Venous leakage
Prostatectomy
Hypertension
Psychogenic impotence
Impotence due to radiation therapy
Spinal cord injury
A constriction ribbon is made of elastic and soft rubber-like material with generally rectangular cross section. A belt with release loop is used for keeping the constrictor in a prearranged tightened position and for unlocking the ribbon.
The material conforms FDA regulation for devices contacting human skin.
For unlocking of the constrictor, the belt's release loop is pulled forward. The belt slips off, allowing easy unwrapping of the constricting ribbon.
A mounting tube comprises a segment of acrylic tube.
The provided text is a 510(k) summary for the ERCO-RIBBON™ constriction device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain details about specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about the study that proves the device meets such criteria based solely on the provided input.
Here's a breakdown of what CANNOT be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This information is completely absent. The document states a claim of "superior safety and performance" compared to predicate devices, but no metrics or specific criteria are provided.
- Sample sized used for the test set and the data provenance: There is no mention of any test set, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of ground truth or experts for performance evaluation.
- Adjudication method for the test set: No test set or adjudication method is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No such study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As this is a physical medical device, not an algorithm, this question is not applicable in the context of the provided document. Even if rephrased for device performance, no standalone performance study details are given.
- The type of ground truth used: No ground truth is discussed in relation to a performance study.
- The sample size for the training set: There is no mention of a "training set" as this is not an AI/ML device and no performance study details are given.
- How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.
What the document does provide in relation to general performance and comparison:
- Claim of Superiority: "Technological differences of Erco-Ribbon™ provide superior safety and performance." This is a general claim, not supported by quantitative data in this summary.
- Comparison to Predicate Devices: The document extensively compares the Erco-Ribbon™ to predicate devices based on design and perceived user experience (e.g., ease of application, comfort, pressure control, removal). It highlights potential issues with predicate devices (excessive pressure, discomfort, difficult placement, painful removal) and suggests that the Erco-Ribbon's design (multi-turn ribbon, user-adjustable tension) addresses these. These are qualitative comparisons based on design features, not quantitative performance metrics from a study.
- Material Conformance: "The material conforms FDA regulation for devices contacting human skin." This is a regulatory conformance statement, not a performance metric from a study.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence based on intended use and design characteristics, arguing for improved user experience and safety. It lacks the specific performance data and study details requested in your prompt.
§ 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.