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The PROLENE Soft (Polypropylene) Mesh is indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

PROLENE Soft* polypropylene mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth. Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of reduced diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE mesh. This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use. PROLENE Soft mesh is knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The bi-directional elastic property allows adaption to various stresses encountered in the body.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PROLENE Soft (Polypropylene) Mesh:

Summary of Acceptance Criteria and Device Performance (PROLENE Soft Mesh)

The document focuses on demonstrating substantial equivalence to predicate devices (PROLENE Mesh and MERSILENE Mesh) rather than defining specific numerical acceptance criteria for a novel performance study. Therefore, the "acceptance criteria" are implicitly met by demonstrating that the new device is either identical in material/intended use or offers improvements without compromising safety and effectiveness.

Study Details:

The document describes a submission for substantial equivalence based on comparisons to predicate devices, rather than a standalone clinical or formal non-clinical performance study with a defined test set and ground truth in the traditional sense for an AI/device performance.

1. Sample size used for the test set and the data provenance:

   • No specific "test set" or clinical data is detailed for the PROLENE Soft Mesh itself. The submission relies on the established safety and effectiveness of its predicate devices and the material (polypropylene).
   • The "performance data" section explicitly states: "Nonclinical laboratory testing was not performed as there is no change to the clinical intended use as compared to the two predicate devices."
   • It mentions "Sufficient bench testing was conducted," but no details on sample size or specific results are provided. This bench testing would likely involve physical property measurements (e.g., flexibility, tensile strength) on samples of the mesh material itself against the predicate devices. Data provenance for this bench testing is not explicitly stated.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. There was no "test set" requiring expert ground truth in this context. The evaluation was a regulatory comparison to predicate devices, relying on existing established knowledge.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No expert adjudication process for a test set was described.

4. 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 a medical device (surgical mesh), not an AI-powered diagnostic, so MRMC studies involving human readers or AI assistance are not relevant here.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithm or AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Implicit "ground truth" derived from established clinical history and performance of predicate devices (PROLENE Mesh and MERSILENE Mesh), and the well-known properties of PROLENE polypropylene suture. The "ground truth" here is the long-standing clinical acceptance and safety profile of the base material and similar devices.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this device submission.

8. How the ground truth for the training set was established:

   • Not applicable. No training set was used.

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