(42 days)
The AMS Large Pore Polypropylene 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 AMS Large Pore Polypropylene Mesh is a knitted mesh of polypropylene fibers. The mesh can be cut to any desired shape or size and resists unraveling.
This document describes the AMS Large Pore Polypropylene Mesh, its intended use, and the basis for its substantial equivalence to predicate devices, but it contains limited information regarding a formal study with acceptance criteria and a detailed comparison of device performance against those criteria. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting a full clinical trial or complex performance study with defined acceptance criteria in the way a medical AI device might.
Here's an analysis based on the available text, addressing your points where possible:
1. A table of acceptance criteria and the reported device performance
The provided text does not include a specific table of acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy) in the way one would see for an AI diagnostic device. Instead, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to predicate devices, meaning it performs similarly in relevant aspects. The study mentioned is a mechanical characterization study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated biocompatible |
| Mechanical Characteristics (for surgical mesh) | Tested for a variety of mechanical characteristics in accordance with FDA's Guidance for the Preparation of a Pre-market Notification for a Surgical Mesh. Reported to be equivalent to the listed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "a variety of mechanical characteristics" were tested. However, it does not specify the sample size for this testing, nor does it provide details on data provenance (country of origin, retrospective/prospective). This would typically involve laboratory testing of the mesh material itself, not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a surgical mesh, a physical medical device, not a diagnostic or AI-driven tool that requires expert interpretation for ground truth establishment. Therefore, this question is not applicable to the provided document. The "ground truth" for mechanical characteristics would be established through standardized engineering and material science tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic studies, which is not relevant for a mechanical mesh device.
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. The device is a surgical mesh; it does not involve human readers, AI assistance, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device would be based on standardized laboratory testing and measurements of the material's mechanical properties and biocompatibility.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, this question is not relevant.
Summary of the Study and Evidence provided:
The provided 510(k) summary explains that the AMS Large Pore Polypropylene Mesh underwent two primary evaluations to demonstrate substantial equivalence to predicate devices:
- Biocompatibility Testing: The material used in the mesh was "demonstrated to be biocompatible." The details of this testing (e.g., specific ISO standards followed, animal studies, in vitro tests) are not provided in this summary but would have been part of the full 510(k) submission.
- Mechanical Characterization: The mesh was "tested for a variety of mechanical characteristics in accordance with FDA's Guidance for the Preparation of a Pre-market Notification for a Surgical Mesh." The critical finding states that the device "has a reputation of equivalence to the listed predicate devices" (Gynemesh Prolene Soft Mesh, Ethicon Prolene Soft Mesh, AMS Sacral Colpopexy Sling). This implies that its mechanical properties (e.g., tensile strength, pore size, elasticity) were found to be within acceptable ranges and comparable to those of already approved meshes.
The acceptance criteria for this type of device are implicitly that its biocompatibility and mechanical properties are comparable to or better than those of the predicate devices, ensuring similar safety and effectiveness for its intended use as tissue reinforcement in pelvic floor prolapse. The study confirming this "equivalence" was likely a series of laboratory-based material characterization tests.
§ 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.