(62 days)
Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are 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.
Parietene™ Duo and Parietene™ Quadra are monofilament polypropylene prolapse repair meshes. The nonabsorbable, polypropylene mesh provides a long-term reinforcement for support structures. Parietene™ Duo Polypropylene Mesh is a pre-shaped mesh for posterior prolapse repair. Parietene™ Quadra Polypropylene Mesh is a pre-shaped mesh for anterior prolapse repair. Parietene™ Duo and Parietene™ Quadra meshes have a soft knit in the central section for compliant organ support and a strong knit in the lateral sides to provide strength for tension-free fixation of the mesh.
The provided text describes a 510(k) summary for the Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes. This document focuses on the substantial equivalence of the device to predicate devices rather than establishing novel performance criteria through a study comparing it to specific acceptance thresholds.
Therefore, the requested information regarding detailed acceptance criteria and the specifics of a study proving the device meets those criteria (especially in the context of AI/algorithms) is not present in the provided text.
The closest information related to "acceptance criteria" is the demonstration of "substantial equivalence" to a predicate device through performance data.
Here's a breakdown of what can be extracted or inferred from the text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Inferred from Substantial Equivalence): The implicit acceptance criterion is that the device's performance characteristics demonstrate "substantial equivalence" to the predicate device, UGYTEX™ Dual Knit Mesh. This implies that its mechanical, biological, and material properties are comparable.
- Reported Device Performance: The document states: "Testing was conducted to determine the performance characteristics of the subject meshes. The results demonstrate that the Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are substantially equivalent to the predicate UGYTEX™ Dual Knit Mesh."
- Specific performance metrics (e.g., tensile strength, pore size, biocompatibility results) are NOT provided in this summary. The summary only states that testing was done and yielded substantial equivalence.
2. Sample size used for the test set and the data provenance
- Not provided. The text does not mention specific sample sizes for any testing nor the provenance of any data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. This device is a surgical mesh, not an imaging or diagnostic AI device that would typically involve experts establishing ground truth for a test set in the way AI performance studies do. The evaluation likely involved laboratory testing by engineers and scientists, and potentially animal studies or clinical trials (though details are not in this summary).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are common in diagnostic accuracy studies for AI, where human interpreters' discrepancies are resolved. This is not relevant for the type of device and evaluation 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
- Not applicable. This device is a surgical mesh, not an AI-assisted diagnostic tool. An MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical mesh, not an AI algorithm.
7. The type of ground truth used
- Ground Truth (Inferred): For a surgical mesh, "ground truth" would relate to its physical properties, biocompatibility, and intended mechanical function. This would be established through laboratory testing conforming to engineering standards (e.g., tensile strength calculations, material composition analysis), biocompatibility testing (e.g., ISO 10993 standards), and possibly animal studies or clinical observations of healing/integration (though specific results are not here). The "ground truth" for showing substantial equivalence would be the established performance characteristics of the predicate device.
8. The sample size for the training set
- Not applicable/Not provided. Surgical mesh devices do not have "training sets" in the context of AI or machine learning. They undergo manufacturing processes and quality control.
9. How the ground truth for the training set was established
- Not applicable/Not provided. See point 8.
In summary, the provided 510(k) summary is for a physical medical device (surgical mesh) and its focus is on demonstrating substantial equivalence to a predicate device based on performance characteristics. It does not contain the kind of information typically found in FDA submissions for AI/ML-driven diagnostic devices regarding specific acceptance criteria, test set details, or human reader performance.
§ 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.