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The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The modified Coloplast Virtue Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.

This document describes the 510(k) summary for the Coloplast Virtue™ Ventral Urethral Elevation Sling System. The submission claims substantial equivalence to previously cleared devices (K082640 and K091152).

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit acceptance criteria or detailed reported device performance in a quantitative manner. The submission relies on demonstrating substantial equivalence through "bench testing compared to the predicate device and existing specifications." This implies that the 'acceptance criteria' were met if the bench test results for the modified device were comparable to the predicate and fell within established specifications, but these specifics are not provided in the summary.

Since no specific performance metrics are provided in the document, a table cannot be constructed with performance data.

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

The document only mentions "bench testing." It does not specify a sample size for the test set, nor does it provide any information on data provenance (e.g., country of origin, retrospective or prospective) for any clinical or non-clinical studies. Bench testing typically refers to laboratory-based evaluations, not human or observational data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since only "bench testing" is mentioned and there are no clinical studies or human-involved test sets described, there is no information provided regarding experts establishing ground truth or their qualifications.

4. Adjudication Method for the Test Set

As there are no clinical studies or human-involved test sets described, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "nonclinical tests" and "bench testing." It does not mention any multi-reader multi-case comparative effectiveness study or any studies involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is a surgical sling system, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The "device performance" would refer to the mechanical and biological performance of the sling itself.

7. The Type of Ground Truth Used

For the "bench testing," the ground truth would be established by engineering and material specifications – i.e., whether the physical properties and performance characteristics (e.g., tensile strength, pore size, biocompatibility) of the modified device meet predefined engineering standards and are comparable to the predicate device. The document does not provide details on these specific ground truths.

8. The Sample Size for the Training Set

This device is a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" with a sample size for machine learning is not applicable.

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

As explained above, the concept of a "training set" for this type of device is not applicable.

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The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The modified Coloplast VIRTUE Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve . and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.

This 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document describes a medical device called the "VIRTUE Ventral Urethral Elevation Sling System" and its substantial equivalence to a previously cleared device. It details the device's components (polypropylene mesh with four arms, sleeves, sutures, and an introducer), its intended use for male stress urinary incontinence (SUI), and the regulatory classification.

The document is a regulatory communication from the FDA to Coloplast Corporation, confirming the substantial equivalence of the modified VIRTUE device. It does not include performance data, clinical study results, or specific acceptance criteria.

Therefore, I cannot provide the requested information from this text.

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The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The Coloplast VIRTUE Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.

The provided text is a 510(k) summary for the Coloplast VIRTUE™ Ventral Urethral Elevation Sling System. The available information primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted from this document, as a such a study (with specific performance metrics, ground truth, and reader studies) appears not to have been conducted or detailed in this 510(k) summary. The submission relies on comparative analysis and bench testing.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document refers to "bench testing" but does not give details on the number of samples or specific test cases.
• Data Provenance: Not specified. Given it's bench testing, it would likely be laboratory-generated data rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not available in the provided document. The study described is bench testing and comparative analysis, not a clinical study involving experts establishing ground truth for performance metrics in a patient context.

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

• This information is not applicable and not available. Adjudication methods are typically used in clinical studies or reader studies where multiple experts assess cases. The described testing is bench testing.

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

• No, an MRMC comparative effectiveness study was not done. The device is a surgical sling system, not an AI or diagnostic imaging device.

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

• Not applicable. The device is a physical surgical implant, not an algorithm.

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

• For the bench testing, the "ground truth" would be objective measurements of physical properties (e.g., tensile strength, elasticity, pore size) and material properties that are compared against predefined specifications or the predicate device's characteristics. The document implies comparison to the predicate device's known characteristics as the "truth" for equivalence.

8. The sample size for the training set

• Not applicable / Not available. The device is a physical product, not an AI algorithm that requires a training set. The "testing" involved bench testing, not machine learning model training.

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

• Not applicable / Not available. (See point 8).

In summary: The 510(k) summary focuses on demonstrating "substantial equivalence" of the Coloplast VIRTUE™ Ventral Urethral Elevation Sling System to a legally marketed predicate device (AMS AdVance Male Sling System) through a comparison of design, materials, performance characteristics (via bench testing), and indications for use. It does not contain details of a clinical study with quantifiable acceptance criteria for diagnostic accuracy, reader performance, or patient outcomes that would typically involve experts, ground truth, or specific sample sizes in the manner implied by the questions.

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