(24 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 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.
§ 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.