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Erco-Vac ™ -C is used to create an erection in men with erectile dysfunction and for augmenting of male potency. Erco-Vac TM -C can be used for patients with following conditions: Diabetes Venous leakage Prostatectomy Hypertension Psychogenic condition Impotence due to radiation therapy Spinal cord injury

Erco-Vac ™ -C is based on the same scientific concept as known marketable vacuum constriction devices. Vacuum applied to penis causes blood inflow, engorgement and state of erection. Constriction device preliminary installed on the edge of vacuum chamber is forced to slip off on the root of the penis. By hindering blood outflow, constriction device sustains erection and makes intercourse possible after removal of vacuum chamber.

This document describes the ERCO-VAC™-C external penile rigidity system, which is a vacuum constriction device intended to create erections in men with erectile dysfunction. The submission claims substantial equivalence to several predicate devices.

1. A table of acceptance criteria and the reported device performance

The provided document does not contain specific acceptance criteria with numerical thresholds (e.g., minimum efficacy rate, maximum complication rate) or the results of a formal study evaluating these criteria for ERCO-VAC™-C. Instead, the submission focuses on establishing substantial equivalence based on intended use and technological characteristics compared to predicate devices.

The "reported device performance" is described qualitatively as "superior performance and safety" compared to predicate devices due to novel design elements.

• Transferable air tight penile seal for adjustable girths
• Constriction device with controllable inward radial pressure (Erco-Ribbon™-C)
• Cuff and quick release loop
• Automatic vacuum release
• Transferring device
• Vacuum chamber with a domed closed end, customized to user's penile anatomy |

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The provided document does not contain information about a test set sample size or data provenance. The submission for K990006 is a 510(k) Pre-Market Notification, which primarily relies on substantial equivalence to legally marketed predicate devices, rather than new clinical study data for device performance.

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)

There is no mention of experts used to establish ground truth for a test set, as no specific test set data is presented.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

No adjudication method is mentioned, as no test set data 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

This device is not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This device is a medical device (external penile rigidity system), not an algorithm. Therefore, a standalone algorithm performance study is not applicable. The device's function involves direct user interaction to achieve its intended purpose.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Since no clinical study data with a test set is provided, there is no mention of the type of ground truth used. The basis for marketing approval is substantial equivalence to predicate devices, meaning the intended use and technological characteristics are similar enough to existing devices.

8. The sample size for the training set

The document does not mention a training set sample size, as this is not a machine learning model.

9. How the ground truth for the training set was established

Not applicable, as this is not a machine learning model.

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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.

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.

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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:

1. 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.
2. 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).
3. 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.
4. Adjudication method for the test set: No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No such study is mentioned.
6. 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.
7. The type of ground truth used: No ground truth is discussed in relation to a performance study.
8. 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.
9. 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.

Ask a specific question about this device

Erco-Vac™ is used to create an erection in men with erectile dysfunction. Erco-Vac™ can be used for patients with following conditions: Diabetes, Venous leakage, Prostatectomy, Hypertension, Psychogenic impotence, Impotence due to radiation therapy, Spinal cord injury.

Erco-Vac™ is based on the same scientific concept as known marketable vacuum constriction devices. Vacuum applied to penis causes blood inflow, engorgement and state of erection. Constriction device preliminary installed on the edge of vacuum chamber is forced to slip off on the root of the penis. By hindering blood outflow, constriction device sustains erection and makes intercourse possible. After releasing of vacuum and vacuum chamber removal, the user is ready to intercourse.

The provided text for the Erco-Vac™ primarily focuses on describing the device, its intended use, and claiming substantial equivalence to predicate devices for regulatory approval (510(k) submission). It does not contain a detailed study demonstrating that the device meets specific acceptance criteria based on quantifiable performance metrics.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, and ground truth establishment cannot be extracted from the provided text. The document is a regulatory submission, not a clinical trial report.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., "device must achieve X level of rigidity in Y% of patients") nor does it report specific device performance against such criteria. It generally states "superior performance" compared to predicate devices due to technological differences, but this is not data-driven.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not describe any specific test set, clinical trial, or patient data used to evaluate the device's performance.

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)

• Cannot be provided. Since there's no described test set or performance study, there's no mention of experts establishing a ground truth for such a study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No test set is described.

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

• Cannot be provided. This question is highly relevant to AI/imaging devices. The Erco-Vac™ is an external penile rigidity system, a mechanical medical device, not an AI or imaging device. Therefore, an MRMC study is not applicable, and no such study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided. As above, the device is a mechanical system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. No performance study with ground truth establishment is described.

8. The sample size for the training set

• Cannot be provided. The device is not an AI/machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

• Cannot be provided. Not applicable due to the nature of the device.

Summary of what the document does provide:

• Intended Use: To create an erection in men with erectile dysfunction, applicable to various conditions like diabetes, venous leakage, prostatectomy, hypertension, psychogenic impotence, impotence due to radiation therapy, and spinal cord injury. (From Section 510(k) Summary and Indications for Use).
• Device Description: An external penile rigidity system (vacuum constriction device) that uses vacuum to draw blood into the penis, and a constriction device to retain the erection. (From Device Description section).
• Technological Improvements claimed:
  • Transferable air-tight penile seal (adjusts to girth without inserts).
  • Constriction device with controllable inward radial pressure (Erco-Ribbon™ allows user to prearrange pressure).
  • Automatic vacuum release upon transfer of seal/constriction device.
  • Transferring device for easy slip-off.
  • Vacuum chamber with a domed closed end. (From Device Description section).
• Comparison to Predicate Devices: Claims "superior performance" due to the novel elements, addressing "deficiencies and drawbacks" of known marketable devices, such as the need for adapter inserts, lack of smooth control over inward pressure, and discomfort/bruises with predicate constriction rings. (From Device Description section).
• Regulatory Classification: Unclassified (78 LKY). (From 510(k) Summary).
• Substantial Equivalence: Claimed to Erercaid (K841257), VED (K901223), and Pos-T-Vac (K960828, K960342). (From 510(k) Summary and FDA letter).

The document is a regulatory submission for premarket notification (510(k)), which typically focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing detailed clinical trial data with specific acceptance criteria and performance metrics.

Ask a specific question about this device

Erco-Vac™ is used to maintain penile rigidity in men with erectile dysfunction.

Erco-Vact can be used for patients with following conditions:

Diabetes

Venous leakage

Prostatectomy

Hypertension

Psychogenic condition

Impotence due to radiation therapy

Spinal cord injury

Erco-Vac™ is based on the same scientific concept as known marketable vacuum constriction devices. Vacuum applied to penis causes blood inflow, engorgement and state of erection. Constriction device preliminary installed on the edge of vacuum chamber is forced to slip off on the root of the penis. By hindering blood outflow, constriction device sustains erection and makes intercourse possible.

After releasing of vacuum and vacuum chamber removal, the user is ready to intercourse.

Vacuum constriction treatment is now recognized as the first line remedy, preferable to other treatments of erection dysfunction - sex therapy, self injections, venous and arterial surgery, implantation of penile prosthesis. It is noninvasive, provides instant results and is applicable to almost all kinds of impotence as well as for augmenting male potency.

At the same time, known marketable devices have deficiencies and drawbacks which make them unacceptable to many potential users.

Erco-Vac™ was developed with the goal to overcome known deficiencies and limitations of vacuum constriction devices. Novelty elements, introduced into the system's structure are listed below:

1. Transferable air tight penile seal.
2. Constriction device with controllable inward radial pressure.
3. Automatic vacuum release.
4. Transferring device.
5. Vacuum chamber with a domed closed end

The provided text is a 510(k) Summary for the ERCO-VAC™ External Penile Rigidity System, dated July 3, 1997. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and studies as one might find for a PMA or de novo submission in contemporary regulatory contexts.

Therefore, the document does not contain a table of acceptance criteria or a study proving the device meets acceptance criteria in the manner one would typically expect for a device seeking a more rigorous approval. The goal of a 510(k) is to show the new device is "substantially equivalent" to an existing predicate device, meaning it has the same intended use and either the same technological characteristics or, if different, that the differences do not raise new questions of safety and effectiveness.

Here's an analysis based on the provided text, highlighting what information is available and what is not available within the scope of your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided 510(k) summary. A 510(k) submission generally does not include specific acceptance criteria for performance endpoints or a detailed report of a study designed to meet those criteria. The submission focuses on comparing the new device's technological characteristics and intended use to predicate devices to demonstrate substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

This information is not available. The document makes no mention of a "test set" for performance evaluation, nor does it describe sample sizes or data provenance (country of origin, retrospective/prospective). The submission relies on a comparison of technological characteristics to predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not available. There is no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not available. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This information is not available. The document does not describe any MRMC study or any study comparing human reader performance with or without AI assistance. The device is a physical medical device, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not available. The device is a physical medical device for erectile dysfunction, not an algorithm, so a standalone performance study in this context is not applicable.

7. The Type of Ground Truth Used

This information is not available. As there is no described performance study or test set, there is no mention of how ground truth would be established (e.g., expert consensus, pathology, outcomes data).

8. The Sample Size for the Training Set

This information is not available. The document does not describe any "training set" as it is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set was Established

This information is not available. As there is no training set mentioned, there is no information on how its ground truth would be established.

Summary of Approach in K972537:

The ERCO-VAC™ 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices. This is achieved by:

• Stating the Intended Use: The device's intended use (to create an erection in men with erectile dysfunction and to maintain penile rigidity in men with erectile dysfunction) is stated and confirmed to be the same as predicate devices.
• Comparing Technological Characteristics: The document details how ERCO-VAC™ is based on the same scientific concept as known marketable vacuum constriction devices. It then highlights novelty elements which are presented as superior performance features over predicate devices, such as:
  • Transferable air-tight penile seal (vs. predicate devices requiring adapter inserts).
  • Constriction device with controllable inward radial pressure ("Erco-Ribbon™") (vs. predicate devices using rings with fixed pressure).
  • Automatic vacuum release.
  • Transferring device.
  • Vacuum chamber with a domed closed end.
• Claiming Equivalence to Specific Predicate Devices: The submission explicitly lists three predicate devices (Eréricaid K841257, VED K901223, Pos-T-Vac K960828, K960342) to which equivalence is claimed.

The FDA's letter (Section {5}) confirms that they 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 use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This approval is based on the comparison provided in the submission and not on a clinical trial with pre-defined acceptance criteria.

Ask a specific question about this device

Erco-Ribbon™ is used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump or naturally).

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 condition

Radiation therapy

Spinal cord injury

A constriction ribbon is made of elastic and soft silicone 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.

For arrangement of Erco-Ribbon™ penile constriction device, the ribbon is wrapped with the tension by multyple turns over the segment of the proximal end of the mounting tube. (or a vacuum chamber, when Erco-Ribbon ™ is used as a part of a vacuum constriction system),

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for the ERCO-RIBBON™ constriction device, primarily focusing on establishing substantial equivalence to previously marketed predicate devices.

Therefore, I cannot provide the requested information in the table or answer the other questions as the data is not present in the given text.

The document describes:

• The intended use of the Erco-Ribbon™.
• A brief description of the device's design and materials.
• A comparison of the Erco-Ribbon™ to predicate constriction rings, highlighting perceived advantages in terms of ease of use and pressure control.
• The FDA's decision of substantial equivalence.

There is no mention of:

• Specific acceptance criteria for performance metrics (e.g., pressure range, material durability, comfort levels).
• Any studies (clinical or benchtop) conducted to demonstrate the device's performance against such criteria.
• Sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or details about training and ground truth for any potential studies.

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