(51 days)
Erco-Ribbon ™ - C 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 ™ - C 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
Erco-Ribbon ™-C is an improved version of Erco-Ribbon ™, using a cuff for forming a shell around the ribbon and a quick release loop for removing the constrictor. A constriction ribbon is made of elastic and soft rubber-like material with generally rectangular cross section.
For arrangement of Erco-Ribbon ™-C penile constriction device, the ribbon is wrapped with the tension by multyple turns over the proximal end of the mounting tube (or a vacuum chamber, when Erco-Ribbon ™-C is used as a part of a vacuum constriction system). Erco-Ribbon ™-C is locked by the cuff in a state with prearranged inward pressure. A quick release loop unlocks the constrictor and allows easy removal of the ribbon. The materials conform FDA regulation for devices contacting human skin. A mounting tube is made of a segment of acrylic tube.
The provided document is a 510(k) summary for the Erco-Ribbon™ -C, a constriction device for penile rigidity. It focuses on demonstrating substantial equivalence to existing predicate devices rather than directly presenting a study with specific acceptance criteria and detailed performance metrics as would be typical for a device providing diagnostic or treatment efficacy data.
Therefore, the information regarding acceptance criteria and a study proving their fulfillment is largely not present in the provided text in the traditional sense you might expect for a diagnostic AI device or certain therapeutic devices. The submission focuses on design and material comparisons to established equivalent devices.
However, I will extract what can be inferred as "acceptance criteria" based on the comparison made and the overarching goal of a 510(k) submission, and then describe how the comparison itself serves as the "study" for showing substantial equivalence.
Here's the breakdown based on your request:
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
The Erco-Ribbon™ -C is a constriction device for penile rigidity that was submitted for 510(k) clearance, asserting substantial equivalence to predicate devices already on the market. In such a submission, "acceptance criteria" are implicitly tied to demonstrating that the new device is as safe and effective as the predicate devices, despite technological differences. The "study" proving this is primarily a comparative analysis of design, materials, and intended use, rather than a clinical trial with statistical endpoints against pre-defined performance metrics.
1. A table of acceptance criteria and the reported device performance
Given the nature of this 510(k) submission, the "acceptance criteria" are derived from the safety and performance characteristics of the predicate devices. The "reported device performance" is a comparative qualitative assessment rather than quantitative measurements from a specific trial.
| Acceptance Criterion (Inferred from Predicate Devices) | Reported Device Performance (Erco-Ribbon™ -C) |
|---|---|
| Safety: | |
| - Avoidance of excessive pressure | "The user may prearrange desirable pressure by changing the tension and number of turns during wrapping." This implies user-controlled pressure, potentially reducing instances of excessive pressure compared to fixed-durometer rings. |
| - Minimization of discomfort/pain | "A multyturn constriction ribbon is much easier to apply than a solid constriction ring as the force necessary to extend multyturn constrictor is much lower than for solid ring." Less painful application and removal due to a quick-release loop and reduced twisting/intertwining with pubic hair. Materials conform to FDA regulations for skin contact. |
| - Ease of application and removal | "Placement of rings presents certain technical difficulties... (for predicate devices)" "A multyturn constriction ribbon is much easier to apply than a solid constriction ring..." "A quick release loop unlocks the constrictor and allows easy removal of the ribbon." |
| - Biocompatibility/Material Safety | "The materials conform FDA regulation for devices contacting human skin." |
| Effectiveness: | |
| - Maintenance of penile rigidity | Same intended use as predicate devices: "restricted blood outflow from the penis after the patient has obtained an erection... to maintain penile rigidity." |
| - Applicability for listed indications | Same indications for use as predicate devices: premature ejaculation, firm but short-lasting erection, and as part of a vacuum constriction system for various erectile dysfunction causes (diabetes, venous leakage, prostatectomy, hypertension, psychogenic conditions, radiation therapy, spinal cord injury). |
| - Reliability of constriction | Achieves constriction through a "multyturn" ribbon. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission does not describe a clinical "test set" with patients. The "test" in this context is the qualitative comparison of design and functionality against 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)
This information is not provided. As no clinical "test set" or diagnostic ground truth was established, no experts in this capacity were involved in the described comparison. The "ground truth" for the submission is the established safety and effectiveness of the predicate devices based on their long-term marketing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided, as there was no test set requiring expert adjudication.
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
An MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices often involving image interpretation or clinical decision support, which is not the function of the Erco-Ribbon™ -C. This device is a mechanical constriction aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not performed in the traditional sense of an algorithm. The device's "standalone performance" is its mechanical function, which is assessed through a comparative description rather than quantitative testing data in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is the established long-term safety and effectiveness of the legally marketed predicate devices to which the Erco-Ribbon™ -C claims substantial equivalence. The argument is that if the new device is sufficiently similar in intended use and fundamental operating principle, and its technological differences lead to superior or at least equivalent safety and performance, then it is substantially equivalent.
8. The sample size for the training set
This information is not provided. There was no "training set" in the context of device development described in this submission, as it's a mechanical device, not an AI algorithm.
9. How the ground truth for the training set was established
This information is not provided, as there was no training set.
Summary of the "Study" (Substantial Equivalence Comparison):
The "study" presented in this 510(k) is a documentary comparison (a "Comparison of design and performance") between the Erco-Ribbon™ -C and several legally marketed predicate devices (ErecAid, Confidence, VED, VET, Pos-T-Vac, and the previous Erco-Ribbon™).
The comparison highlights technological differences of the Erco-Ribbon™ -C (e.g., multi-turn ribbon design, quick release loop, cuff for shell formation) and argues how these differences provide superior safety and performance compared to the predicate's fixed-size, molded constriction rings. Key arguments for superior safety and performance included:
- User-adjustable pressure: Allows for smooth control of pressure, reducing instances of excessive pressure and discomfort.
- Easier application: Multi-turn ribbon is easier to apply than solid rings, requiring less force to extend.
- Easier removal: Quick release loop allows for easy removal.
- Reduced discomfort/pain: Less twisting/intertwining with pubic hair, and less pain during removal.
- Material conformity: Materials meet FDA regulations for skin contact.
The conclusion is that despite technological differences, the Erco-Ribbon™ -C has the same intended use as the predicate devices and its design features lead to superior safety and performance, thus establishing substantial equivalence.
§ 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.