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PROLENE™ Soft Mesh is indicated for the repair of abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

PROLENE™ Soft Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies. The implant device is composed of knitted filaments of extruded polypropylene. Blue PROLENE™ monofilaments have been integrated to produce contrast striping in the mesh.

PROLENE™ Soft 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.). 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. Polypropylene 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.

This document is a 510(k) premarket notification for a medical device called PROLENE™ Soft Polypropylene Mesh. It is a submission to the FDA demonstrating substantial equivalence to previously cleared devices. Therefore, it does not describe a study proving the device meets acceptance criteria in the typical sense of a clinical trial or performance characterization study that would establish specific performance metrics against an established ground truth.

Instead, the core of this document is to demonstrate that the new device is "substantially equivalent" to existing, legally marketed predicate devices. This means that the acceptance criteria are essentially met if the new device is shown to be as safe and effective as the predicates, based on having the same technological characteristics and intended use, or different characteristics that do not raise new questions of safety and effectiveness.

Here's an breakdown based on your request, with the understanding that the context is a 510(k) submission for substantial equivalence rather than a de novo performance study:

1. Table of acceptance criteria and the reported device performance

The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to a predicate device, as opposed to meeting specific numerical performance thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a "test set" in the context of an AI/algorithm performance study. A 510(k) submission for substantial equivalence primarily relies on existing data and characteristics of the predicate devices. No new clinical or performance data from a specific test set is presented.

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)

Not applicable. The ground truth in this context is the regulatory clearance and established safety and effectiveness of the predicate devices. There is no new "ground truth" establishment for a test set described in this document.

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

Not applicable. There is no test set or adjudication process 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-powered diagnostic tool, so an MRMC study is irrelevant to this submission.

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 algorithm.

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

The "ground truth" in this context is the established safety and effectiveness of the predicate devices (PROLENE™ Soft Polypropylene Mesh K163152 and PROLENE™ Soft (Polypropylene) Nonabsorbabale Synthetic Surgical Mesh K001122), as determined through their previous FDA clearances based on their own data and clinical history. The current submission's "ground truth" is that these predicate devices are already shown to be safe and effective.

8. The sample size for the training set

Not applicable. This document does not describe a training set as it's not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. This document does not describe a training set.

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PROLENE Soft Polypropylene Mesh may be used 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 Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of hernias and other fascial defects. The implant device is composed of knitted filaments of extruded polypropylene. Blue PROLENE™ monofilaments have been integrated to produce contrast striping in the mesh. PROLENE Soft 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.). Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of 3.5 mil diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE Mesh. Polypropylene 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 is designed to allow adaption to various stresses encountered in the body.

Here's an analysis of the provided text regarding acceptance criteria and performance studies. It appears the document describes a 510(k) premarket notification for a surgical mesh, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing new acceptance criteria or full device performance in the same way an AI/software device would.

Based on the provided text, the device is PROLENE Soft Polypropylene Mesh and the study is focused on demonstrating substantial equivalence to a predicate device (PROLENE Soft Polypropylene Mesh, K001122), particularly for a new larger size (50 cm x 50 cm).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

This document describes a 510(k) submission for a physical medical device (surgical mesh), not a software or AI device that would typically have a "test set" of data in the same sense. The "test set" here refers to the samples of the mesh device undergoing various physical, chemical, and biological performance tests.

• Sample Size: Not explicitly stated for each individual test. The document mentions "the subject device" or "the new device" generically when discussing biocompatibility, sterility, and bench testing, implying a representative number of samples were tested per standard protocols for each type of evaluation.
• Data Provenance: The studies were conducted by Ethicon, Inc. (a Johnson & Johnson company) as part of their design validation and verification processes. The data appears to be prospective in the sense that the tests were performed specifically for this 510(k) submission to demonstrate the characteristics of the new, larger mesh size. It's not clinical data from patients, but rather lab/bench test data. The country of origin of the data is not specified, but the submission is to the U.S. FDA, and the company is based in Somerville, New Jersey, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable in the context of this 510(k) submission for a physical surgical mesh.

• "Ground truth" for physical device testing typically refers to objective measurements and adherence to established standards (e.g., ISO, ANSI/AAMI), not expert consensus on medical images or patient outcomes.
• The tests described are laboratory evaluations (biocompatibility, sterility, mechanical properties), not clinical assessments requiring expert interpretation of results.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or AI performance evaluations to reconcile discrepancies among human readers or experts. For the physical and biological testing described, results are typically objective measurements against predefined acceptance criteria, not subjective interpretations requiring adjudication.

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

This information is not applicable. An MRMC study is a type of clinical study used to evaluate the diagnostic accuracy of imaging systems or AI algorithms by comparing performance with and without the AI. The device in question is a surgical mesh; it does not involve human readers interpreting images or data, nor does it incorporate AI.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This information is not applicable. This refers to the performance of an AI algorithm independent of human interaction. The device is a physical surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

As mentioned in point 3, the concept of "ground truth" for this type of device submission is different from that used for diagnostic AI. The "ground truth" for the tests performed on the PROLENE Soft Polypropylene Mesh is based on:

• Objective Measurement Standards: Adherence to established international and national standards (e.g., ISO 10993-1:2009 for biocompatibility, ISO 10993-7:2008 for EO/ECH residuals, ANSI/AAMI ST72:2011 for endotoxins, ISO 11737-1 for bioburden).
• Predicate Device Characteristics: Comparison of various physical and performance characteristics to the legally marketed predicate device (K001122). The predicate device itself acts as a benchmark of "known safe and effective" characteristics.
• Design Specifications: The device met its internal design and performance specifications as part of design validation and verification.

8. The Sample Size for the Training Set

This information is not applicable. A "training set" is relevant for machine learning algorithms. This device is a physical medical implant.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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