(59 days)
The UGYTEX® Dual Knit Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.
The Sofradim UGYTEX® Dual Knit Mesh is a monofilament, polypropylene mesh coated in the central portion with an absorbable hydrophilic film of porcine collagen. The nonabsorbable, polypropylene mesh provides a long-term reinforcement for support structures. The hydrophilic film minimizes visceral attachment to the mesh which may occur during the healing process. The UGYTEX Dual Knit Mesh will be offered in various configurations which may include a rectangular sheet, anterior repair system and posterior repair system.
The provided document is a 510(k) summary for the UGYTEX® Dual Knit Mesh, a surgical mesh. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, not for proving clinical efficacy against specific acceptance criteria in the way a pharmaceutical trial or a software algorithm study would.
Therefore, many of the requested categories are not applicable to this document. The "study" mentioned here refers to performance testing to demonstrate substantial equivalence, not a clinical trial or an AI algorithm validation study.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria in a quantitative, measurable way that would typically be used for complex device performance (e.g., sensitivity, specificity, accuracy). Instead, it states that the device is "substantially equivalent" to a predicate device based on "performance testing."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence in material, function, performance, and design to the predicate device (UGYTEX® Mesh K033376). | "The test results showed that the Sofradim UGYTEX® Dual Knit Mesh is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document only references "appropriate testing."
- Data Provenance: Not specified, but likely refers to in-vitro or bench testing of the mesh material and design, rather than human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was not a study requiring expert-established ground truth for a test set. The assessment was likely based on engineering and material science evaluations.
4. Adjudication method for the test set
- Not applicable. This was not a study requiring adjudication of varied interpretations.
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
- Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or software device.
7. The type of ground truth used
- The "ground truth" implicitly used was likely engineering specifications and performance characteristics of the predicate device (UGYTEX® Mesh K033376) and established material science standards for surgical mesh.
8. The sample size for the training set
- Not applicable. This type of submission does not involve training sets in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable.
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.