(37 days)
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
| Acceptance Criteria (What they aimed to achieve) | Reported Device Performance (How it met the criteria) |
|---|---|
| Design Equivalence to Predicate Device: The device's design should be substantially equivalent to the American Medical Systems (AMS) AdVance Male Sling System. | The Coloplast VIRTUE™ system is stated to be "substantially equivalent in design" to the predicate device. |
| Material Equivalence to Predicate Device: The device's materials should be substantially equivalent to the AMS AdVance Male Sling System. | The Coloplast VIRTUE™ system is stated to be "substantially equivalent in... materials" to the predicate device. The device consists of polypropylene mesh. |
| Performance Characteristics Equivalence to Predicate Device: The device's performance characteristics should be substantially equivalent to the AMS AdVance Male Sling System. | The Coloplast VIRTUE™ system is stated to be "substantially equivalent in... performance characteristics" to the predicate device. This was supported by "bench testing compared to the predicate device." |
| Indications for Use Equivalence to Predicate Device: The indications for use should be substantially equivalent to the AMS AdVance Male Sling System. | The Coloplast VIRTUE™ system is stated to be "substantially equivalent in... indications" to the predicate device: "an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI)." |
| Biocompatibility: The device should be biocompatible. | "Biocompatibility testing performed on the subject device" supported substantial equivalence. Specific acceptance criteria or results are not provided. |
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.