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

Device Description

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.

AI/ML Overview

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.

Summary

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K990008

ersum22d8

ERCONS, Inc

66 Overlook Terrace, s-te 2E New York, NY 10040 Tel. 1-212-927 3275 Fax 1-212-927 7387

510(k) SUMMARY

for

ERCO-RIBBON ™-- C

Constriction Device for Penile Rigidity

Submitter: Dr. Yakov Altshuler, Vice President

Date: Dec. 22, 1998

Trade name - Erco-Ribbon ™-C

Common name - constriction device for external penile rigidity system

Equivalence is claimed to:

ErecAid	Osbon Medical Systems, Ltd.	K841257
Confidence	Performance, Inc.	K891125
VED	Mission Pharmacal Co.	K901223
VET	VET-CO, Inc.	K902240
Pos-T-Vac	POS-T-VAC	K960828
Erco-Ribbon TM	Ercons, Inc.	K981343
Code of Federal Regulation (CFR) Number:		Unclassified
Product Code:		78 LKY

PATENT PENDING Erco-Ribbon ™-C CONFIDENTIAL Dec.1998

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Intended Use

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 achive a natural erection, a vacuum constriction system may help him to overcome this dysfinction.

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 condition Impotence due to radiation therapy Spinal cord injury

PATENT PENDING Erco-Ribbon ™-C CONFIDENTIAL Dec.1998

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DESCRIPTION

SUBSTANTIAL EQUIVALENCY COMPARISON

Comparison of design and performance of marketable constriction rings and Erco-Ribbon ™-C is made with consideration of the impact of device's design on its safety and effectiveness.

Considered marketable Predicate devices and Erco-Ribbon ™-C are constriction devices with the same intended use, but have different technological characteristics.

PATENT PENDING Erco-Ribbon ™-C CONFIDENTIAL Dec.1998

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Predicate devices:

To provide sufficient inward pressure on erected penis, one or more of constriction rings have to be placed at the edge of an open end of the vacuum chamber.

Rings are molded of natural or synthetic rubber with different durometer numbers, usually in the range of 30 to 60 and are manufactured in large, medium and small sizes. To provide acceptable inward pressure, selection for individual users is based on size, durometer and a number of constriction rings used together. Despite high cost due to a number of expensive molds, there is no way to provide smooth control of the pressure which happens to be excessive and causes discomfort, numbness, bruises. Placement of rings presents certain technical difficulties. Recognizing this problem, special cone-shaped applicators are added to the system. Applicators facilitate the problem, but complicate the system and increase its cost.

Discomfort and pain may be caused by twisting of doubled rings during their transfer onto the penis and because of intertwining with pubic hair. Removal of constriction ring from erected penis could be painful too, especially when two or more rings are used together. In this case after removal of the first ring the penis is still engorged, as the remaining ring prevents blood outflow.

PATENT PENDING Erco-Ribbon ™-C CONFIDENTIAL Apr,1998

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Erco-Ribbon ™-C:

With the constrictor of given properties and dimensions, the user may prearrange desirable pressure by changing the tension and number of turns during wrapping. The present design radically reduces major technical difficulties of constriction ring associated with its placement on the vacuum chamber. 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.

SUMMARY:

Erco-Ribbon ™-C has the same intended use as Predicate devices. Technological differences of Erco-Ribbon ™-C provide superior safety and performance.

Erco-Ribbon ™-C is substantially equivalent to constriction devices that have been marketed for many years.

PATENT PENDING Erco-Ribbon ™-C CONFIDENTIAL Dec.1998

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 1999

Yakov Altshuler, Ph.D. Vice President ERCONS, Inc. 66 Overlook Terrace, Suite 2E New York, NY 10040

Re: K990008 Erco-Ribbon™ -C, Accessory to Vacuum Erection Device Dated: December 23, 1998 Received: January 4, 1999 Unclassified/Procode: 78 LKY

Dear Dr. Altshuler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act, You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

signature

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K990008

510(k) Number

Page 1 of 1

Device Name: Erco-Ribbon ™ -C

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation Evaluation (ODE)

Prescription Use __ OR Over-The-Counter Use

(Per 21 CFR 8 __) (Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

4990008

and Radiological Devic

510(k) Number_

Regulation Number and Section

§ 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.