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ProGrip™ Self-Gripping Polyester Mesh is indicated for inguinal and incisional hernias repair.
Parietex™ Plug and Patch System is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach.
ProGrip™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.

ProGrip™ Self-Gripping Polyester Mesh: The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polyester and have polylactic acid monofilament resorbable pins on one of the sides. These pins facilitate placing, positioning and fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps orientation. The monofilament polylactic acid pins are bioresorbable and contribute to the fixation of the mesh to surrounding tissue during at least 8 weeks. The polylactic acid pins degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO and H2O.
Parietex™ Plug and Patch System: The Parietex™ Plug and Patch System is a kit composed of: a pre-cut patch made from monofilament polyester; a semi-resorbable disk which is a bi-component made of polyester monofilament and polylactic acid.
ProGrip™ Laparoscopic Self-Fixating Mesh: The mesh is made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable film made of collagen from porcine origin and glycerol, on the other side. The grips allow positioning and fixation of the mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh presents a green band (polyester dyed with D&C green no. 6) to facilitate their orientation. The monofilament polylactic acid grips are bioresorbable and provide the fixation of the mesh to surrounding tissue for at least 8 weeks. The polylactic acid grips degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O.

This medical device submission (K142900) is for a change in the raw material formulation of several surgical mesh products. The purpose is to demonstrate that the new formulation of polyester yarn does not change the substantial equivalence of the modified devices to their existing, legally marketed predicate devices. Therefore, the "acceptance criteria" and "device performance" are not presented in terms of clinical accuracy metrics, but rather in terms of demonstrating equivalent performance characteristics through bench testing and biocompatibility.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission is for a material change in a surgical mesh, not a diagnostic AI device. Therefore, there is no "test set" in the traditional sense of patient data or clinical images. The "test sets" here refer to:

• Bench Test Samples: The document doesn't specify the exact number of mesh samples or tests conducted for the bench testing. This information would typically be detailed in the full 510(k) submission, but not in the summary.
• Biocompatibility Test Samples: Similarly, the document does not specify the number of animals or in-vitro tests performed for biocompatibility.
• Data Provenance: The data provenance is from bench testing and preclinical studies conducted by the manufacturer (Sofradim Production/Covidien) to evaluate the new polyester formulation. These are not "retrospective or prospective" in the clinical trial sense, but rather laboratory-based evaluations. The country of origin for the manufacturing entity is France (Sofradim Production) and the contact person is in the US (Connecticut).

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

This question is not applicable to this type of 510(k) submission. There is no "ground truth" derived from expert review of patient data for an AI or diagnostic tool. The "ground truth" here is established by the scientific and engineering principles of material science, biocompatibility testing (toxicology and pathology experts for animal studies if applicable), and mechanical testing, following recognized standards (e.g., FDA guidance for surgical mesh, ISO 10993-1).

4. Adjudication Method for the Test Set

Not applicable. There is no human adjudication process involved in determining the "truth" for bench testing or biocompatibility studies of a material change. The results are objective measurements against established criteria/standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation of images) to measure human performance with and without AI assistance. This submission is for a surgical mesh material change, which does not involve human readers interpreting cases.

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

No, a standalone performance study was not done. This concept applies to AI algorithms performing a diagnostic task independently. This submission is for a surgical mesh material change.

7. The Type of Ground Truth Used

The "ground truth" used is based on:

• Objective physical and mechanical measurements from bench testing of the mesh material (e.g., tensile strength, pore size, burst strength – implied by "performance characteristics" and "FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh").
• Biocompatibility test results against established criteria for cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic toxicity, genotoxicity, implantation, and hemocompatibility, as defined by ISO 10993-1 for permanent implants.
• Stability data demonstrating the integrity of the material over time.

These are not "expert consensus," "pathology" (in the clinical sense for a patient diagnosis), or "outcomes data" from clinical trials.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The material change is evaluated through direct testing against established scientific and regulatory standards.

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

Not applicable, as there is no training set for an AI model.

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PARIETEX™ PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.

PARIETEX™ PROGRIP™ Mesh will be available in 2 shapes:
Pre-cut, elliptic slit mesh with a self-gripping overlapping flap. Right or left side.
Rectangular simple mesh.
These meshes and the overlapping flaps of the pre-cut versions are made from knitted monofilament polyester with monofilament polylactic acid (PLA) resorbable pins on one side. The PLA pins facilitate placing, positioning and fixation of the overlapping flap and the meshes to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps in orientation.

The acceptance criteria and study proving device performance are not explicitly detailed within the provided text beyond a general statement that "Bench and animal testing has been conducted to evaluate the performance characteristics of PARIETEX™ PROGRIP™ Mesh. Results of mechanical property testing show that PARIETEX™ PROGRIP™ has similar performance characteristics to the predicate PARIETEX™ Mesh."

Therefore, I cannot provide a detailed table of acceptance criteria, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, or specifics on ground truth establishment for a training set.

Based on the provided information, I can deduce the following:

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

2. Sample sized used for the test set and the data provenance

• Test set sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "Bench and animal testing."

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

Not applicable. The study involved bench and animal testing, not human expert evaluations for establishing ground truth in the context of diagnostic performance.

4. Adjudication method for the test set

Not applicable. The study involved bench and animal testing.

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 is a medical mesh device, not an AI-powered diagnostic tool, so an MRMC study is not relevant and was not performed.

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

Not applicable. This is a medical mesh device, not an algorithm.

7. The type of ground truth used

For mechanical properties, the "ground truth" would be established by predefined engineering specifications or comparison against the predicate device's measured performance. For material biocompatibility, the "ground truth" is adherence to ISO 10993-1 and/or USP standards.

8. The sample size for the training set

Not applicable. This is a medical mesh device, not a machine learning model requiring a training set.

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

Not applicable. This device does not use a training set in the context of machine learning.

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