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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-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.

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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.

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