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Parietene™ macroporous mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair.

Parietene™ macroporous mesh is designed for extraperitoneal mesh placement only, for the repair of abdominal wall hernias by laparoscopic or open approach.

Parietene™ macroporous mesh is a non-absorbable synthetic surgical mesh made of two-dimensional (2D) monofilament polypropylene knitted textile.

Parietene™ macroporous mesh is offered in square flat sheet version (50cm x 50cm).

The non-absorbable textile is designed to ensure long term reinforcement of soft tissues. The macroporous textile provides strength required to withstand biomechanical stresses throughout the healing period, while allowing for tissue ingrowth. As the textile integrates, host tissue ingrowth is intended to provide strength to the repair.

The detailed composition listed below refers to the estimated maximum amount of each material and substance to which a patient can be exposed when 1 unit of the largest size of Parietene™ macroporous mesh is implanted (i.e. PPM5050). This amount could be less if the mesh is trimmed by the practitioner prior to implantation.

Mesh composition: monofilament polypropylene yarn (up to 11.5 g)

This FDA 510(k) clearance letter is for a surgical mesh (Parietene™ Macroporous Mesh, PPM5050), not an AI-powered diagnostic device. Therefore, the requested information regarding AI device acceptance criteria, study methodologies (MRMC, standalone performance), expert ground truth establishment, training sets, and data provenance is not applicable to this document.

The document discusses the substantial equivalence of the new mesh size (50cm x 50cm) to previously cleared predicate devices based on:

• Performance testing: In-vitro (bench) tests for trocar compatibility, bursting strength, deflection, uniaxial tensile maximum force and elongation, and tear strength.
• Biocompatibility evaluation.
• Sterilization validation.
• Literature and MAUDE database review of predicate and reference devices.

There is no mention of an AI algorithm, human readers, or image interpretation in this clearance.

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Parietene™ macroporous mesh is intended for the repair of hemias or other fascial deficiencies that require the addition of a reinforcing material.

The Parietene™ Macroporous Mesh is a non-absorbable synthetic surgical mesh made of bi-dimensional monofilament polypropylene textile. The Parietene™ Macroporous mesh is offered in a flat sheet and pre-cut mesh. The pre-cut mesh facilitates the repair of inguinal hernias via the anterior approach using a tension free technique. Parietene™ Macroporous Mesh is a single use device, presented sterile and unitary packaged in a single pouch and provided in a commercial box or sleeve with the labels and instructions for use. The device can be packaged in single pack (1 unit per sleeve) or multipack (3 or 6 units per box).

The provided text is a 510(k) summary for the Parietene™ Macroporous Mesh. It describes a mesh product for hernia repair and focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria based on a clinical study of its performance in patients.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and ground truth types cannot be found in this document, as it primarily deals with engineering and material equivalence.

However, based on the text, I can infer the following about the specific "performance data" mentioned:

1. A table of acceptance criteria and the reported device performance:

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

• Test Set Sample Size: Not specified for the trocar compatibility test.
• Data Provenance: The study was an "In vitro (bench) test," meaning it was conducted in a laboratory setting, not on human subjects.

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

• Not applicable/not specified. The test was an in vitro bench test, implying objective measurements rather than expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable. As an in vitro bench test, it would involve direct measurement and comparison to predefined thresholds, not expert 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:

• No. This document does not mention any MRMC comparative effectiveness study or AI assistance. The device is a surgical mesh, not an AI diagnostic tool.

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:

• For the "trocar compatibility" test: The ground truth would likely be based on objective physical measurements and engineering specifications, determined by the manufacturer, rather than expert consensus, pathology, or outcomes data, which are typically associated with clinical or diagnostic studies.

8. The sample size for the training set:

• Not applicable. This document describes a medical device, not a machine learning algorithm that would require a training set.

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

• Not applicable. No training set for an algorithm is mentioned.

Summary of the Study:

The primary study mentioned in this 510(k) summary is an in vitro (bench) test designed to evaluate the trocar compatibility of the Parietene™ Macroporous Mesh. The document states that "The results demonstrate that the subject device successfully met the established acceptance criteria and is substantially equivalent to the predicate device." No specific details about the methodology, sample size, or precise acceptance criteria for this bench test are provided in the excerpt. The substantial equivalence argument largely relies on the fact that "there is no change in the materials and manufacturing processes except in the instructions for use" compared to the predicate device.

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The Parietene™M Macroporous Mesh is intended for the repair of hemias or other fascial deficiencies that require the addition of a reinforcing material.

The Parietene™ Macroporous Mesh is a non-absorbable synthetic surgical mesh made out of bi-dimensional monofilament polypropylene textile. The Parietene™ Macroporous mesh is offered in a flat sheet and pre-cut mesh. The pre-cut mesh facilitates the repair of inguinal hernias via the anterior approach using a tension free technique.

This submission is for a medical device cleared via a 510(k) pathway, specifically a surgical mesh (Parietene™ Macroporous Mesh). This type of clearance relies on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria as you might see for a diagnostic AI device or a drug.

Therefore, the input document does not contain the kind of information requested in your prompt regarding acceptance criteria, device performance, study designs, sample sizes, expert ground truth, or MRMC studies. These elements are typically found in submissions for AI/ML-based diagnostic devices or complex medical devices requiring de novo or PMA pathways.

Instead, this 510(k) summary focuses on demonstrating that the new device, Parietene™ Macroporous Mesh, is substantially equivalent to legally marketed predicate devices (PROLENE™ Soft (Polypropylene) Mesh (K001122) and Parietene™ Flat Sheet Mesh (K140941)).

Here's a breakdown of what can be extracted and why other parts of your request are not applicable based on this document:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The document does not specify quantitative "acceptance criteria" in the way a diagnostic study would (e.g., target sensitivity, specificity). Instead, the acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device. This is achieved by showing similar technological characteristics and performance.
• Reported Device Performance: The document lists the types of bench tests performed, but does not provide numerical results for either the subject device or the predicate device that would allow for a direct comparison table. It only states that "The bench results demonstrate that the device is substantially equivalent to the predicate PROLENE™ Soft (polypropylene) Mesh (K001122)."

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

• This information is not provided in the document. Bench testing for medical devices typically involves specific numbers of samples for each test (e.g., n=5 or n=10 per test), but these details are not disclosed in this high-level 510(k) summary. Data provenance (country of origin, retrospective/prospective) is also not applicable as these are laboratory bench tests, not clinical studies.

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

• This is not applicable. This document describes bench testing of a physical medical device, not a diagnostic algorithm that requires expert interpretation for ground truth.

4. Adjudication method for the test set:

• This is not applicable for the same reasons as point 3.

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 is not applicable. This is a physical surgical mesh, not an AI/ML diagnostic device, so MRMC studies are irrelevant.

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

• This is not applicable. This is a physical surgical mesh, not an algorithm.

7. The type of ground truth used:

• For the bench tests, the "ground truth" would be established by standardized laboratory test methods and measurements (e.g., using calibrated equipment to measure thickness, strength, pore size, etc.). It's not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

• This is not applicable. This is a physical surgical mesh, not an AI/ML algorithm that requires a training set.

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

• This is not applicable for the same reasons as point 8.

In summary, the provided document is a 510(k) summary for a surgical mesh, focusing on demonstrating substantial equivalence through bench testing. It does not contain the detailed clinical study data, expert consensus, or AI/ML-specific information requested in your prompt.

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