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ProGrip™ laparoscopic self-fixating mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.

Both the predicate and the proposed mesh are 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 incorporates a green band to facilitate 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.

The provided text describes a 510(k) submission for Sofradim Production's ProGrip™ Laparoscopic Self-Fixating Mesh, seeking to add new sizes to an existing product family. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with detailed acceptance criteria and performance metrics for a medical device that produces quantitative or qualitative outputs (like an AI/ML algorithm).

Therefore, based on the provided text, it's not possible to provide a table of acceptance criteria and reported device performance in the way typically expected for an AI/ML device or a device with measurable performance output. The "performance data" mentioned in the document refers to physical characteristics and compatibility of the mesh sizes with trocars, not clinical outcomes or diagnostic accuracy.

Here's an analysis based on the information provided, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission is for a physical medical device (surgical mesh) and primarily concerns adding new sizes, the "acceptance criteria" are related to physical properties and compatibility, not a performance metric like sensitivity, specificity, or accuracy for an AI/ML device.

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

• Sample Size: Not explicitly stated. The text mentions "bench performance evaluations were completed to verify that the proposed additional sizes... are compatible with 10mm and/or 12mm trocars." It doesn't specify how many meshes of each size were tested.
• Data Provenance: This is bench testing of physical devices (surgical mesh). The country of origin of the data is not specified, but the submitter is "Sofradim Production (subsidiary of Covidien LLC)" with an address in Trevoux, France. The data is prospective in the sense that it was generated for this submission.

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

Not applicable. The "ground truth" for this type of physical device testing is the direct measurement and observation of physical properties and functionality (e.g., whether the mesh passes through the trocar, visual integrity, number of gripping points). It does not involve expert interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. This is objective bench testing of physical properties, not a subjective assessment 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

Not applicable. This submission is for a physical surgical mesh, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is for a physical surgical mesh.

7. The Type of Ground Truth Used

The ground truth for the bench testing was based on:

• Direct observation of physical events (passage through trocar).
• Visual inspection criteria.
• Quantitative measurement against a defined specification (e.g., number of gripping points).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; therefore, there is no training set in that context. The "training" in manufacturing comes from established material compositions and manufacturing processes which are stated to be unchanged from the predicate device.

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

Not applicable. As there is no AI/ML training set, this question is not relevant. The "ground truth" for the predicate device's design and manufacturing processes would have been established through extensive design validation, material testing, and historical performance data, none of which are detailed here beyond the statement of "ProGrip™ Laparoscopic Self-Fixating Mesh new sizes are composed of biocompatible materials that are in compliance with ISO 10993-1 standard." and that materials and manufacturing processes have not changed.

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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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PROGRIP™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.

The PROGRIP™ Laparoscopic Self-Fixating Mesh is available in anatomical and rectangular shapes. The mesh is made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable collagen film on the other side. The film is made up of collagen from porcine origin and glycerol. The grips allow positioning and fixation of mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh presents a green band that facilitates mesh orientation No changes to product have been made in this submission.

This 510(k) submission (K123479) for the PROGRIP™ Laparoscopic Self-Fixating Mesh is not a study that proves the device meets specific acceptance criteria through clinical trials or performance testing as would be described for an AI/ML device.

Instead, this submission is a request to the FDA to remove a specific final product specification (lower specification of extractible pH) for an already legally marketed device (PROGRIP™ Laparoscopic Self-Fixating Mesh, K120897). The core assertion is that this change does not impact the device's intended use, does not alter its fundamental scientific technology, and does not require additional performance data.

Therefore, many of the requested elements for an AI/ML device study (like sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) are not applicable and not present in this document.

Here's an breakdown based on the provided text, focusing on what is relevant to a 510(k) submission for a modification to a predicate device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with typical performance metrics (like sensitivity, specificity, AUC) for a new device. Instead, it discusses the impact of a specification change on the effectiveness for intended use.

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

• Not applicable. This submission is for a modification to a previously cleared medical device, not a new device requiring a clinical performance study with a test set. The justification relies on the existing predicate device's performance and the argument that the change is minor.

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

• Not applicable. No expert review panel or ground truth establishment for a test set is mentioned, as this is not a study evaluating diagnostic or predictive performance.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method is 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/ML diagnostic or assistive tool for human readers. Therefore, 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 is not an algorithm or AI device.

7. The type of ground truth used:

• Not applicable. As there is no "test set" in the context of an AI/ML study, there is no discussion of ground truth derived from pathology, outcomes data, or expert consensus. The "ground truth" for this submission is implicitly the established safety and efficacy profile of the predicate device (K120897), which this modified device claims to be substantially equivalent to, despite a minor change in a manufacturing specification.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set mentioned.

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

• Not applicable. No training set exists for this device.

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