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Symbotex™ Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries.
ProGrip™ Self-Gripping Polyester Mesh is intended for use in reinforcement of abdominal wall soft tissues where a weakness exists in procedure involving inguinal and incisional hernias repair.
Parietex™ Hydrophilic 2D 3D Anatomical Mesh is intended for reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving inguinal and incisional hernia repairs.
Versatex™ Monofilament Mesh is intended for reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernia repairs.

The purpose of this Special 510(k) is to notify the Agency the changes made on Instructions for Use. There is no change performed on the devices itself, and the device description is identical to those provided for predicate devices Symbotex™ Composite Mesh (K142908), ProGrip™ Self-Gripping Polyester Mesh (K142900), Parietex™ Hydrophilic 2D 3D Anatomical Mesh (K173796) and Versatex™ Monofilament Mesh (K150091).
Symbotex™ Composite Mesh is made out of a three-dimensional monofilament polyester textile which is covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol. The collagen film is essentially degraded in less than 1 month. For "Flat sheet" (SYM reorder codes): A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "Flat Sheet with sutures" (SYM-F reorder codes): Nonabsorbable pre-placed sutures are tied to the three-dimensional mesh. A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "With flap" (SYM-OS reorder codes): A dyed (D&C Green No. 6) bi-dimensional monofilament polvester textile flap is attached to the threedimensional reinforcement and helps place and fix the 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 CO2 and H2O.
Two or three-dimensional multifilament polyester wall reinforcements.
The two-dimensional mesh, with rectangular pores, is available in two different textures: a standard version (TEC references) and a rigid version (TECR references). The textures and transparencies of this mesh make them particularly suitable for the treatment of parietal affections, in particular inguinal hernias, through laparoscopic approach.
The three-dimensional mesh (TET references) has hexagonal pores. The flexibility, porosity and low density of this mesh make it particularly suitable for the treatment of parietal affections, in particular incisional and inquinal hernias, through open approach.
The Parietex™ hydrophilic 2-dimensional mesh, hydrophilic 3dimensional mesh and hydrophilic anatomical mesh has been adapted for various techniques of abdominal repair. The rectangular mesh is designed for the repair of inguinal and incisional hernias in a pre-peritoneal or pre-muscular approach. The pre-cut and slit mesh is suitable for the repair of inguinal hernias via anterior approach using the tension free technique. The folding mesh (in two-dimensional textile) is designed for the repair of direct or indirect inguinal hernias through a laparoscopic approach (trans-abdominal or pre-peritoneal or totally extra-peritoneal). Some codes have a slit for the passage of the cord.
The anatomical mesh is mainly designed for the repair of inquinal hernias via laparoscopic or posterior open procedures and is available for the left and/or right side.
Versatex™ Monofilament Mesh is made of macroporous three-dimensional monofilament polyester textile. Largest sizes include a green dyed monofilament polyester (D&C Green No. 6) marking that is positioned in the center of the textile to help center and orient the mesh.

This document is a 510(k) summary for several surgical mesh products submitted to the FDA. The submission is not for a new device but rather to update the Instructions for Use (IFU) for existing, already cleared devices to comply with new European regulations and for general readability improvements. Therefore, there is no study described in this document that proves a device meets acceptance criteria related to clinical performance or effectiveness, as this is solely a labeling update submission.

The document explicitly states: "There is no change performed on the devices itself, and the device description is identical to those provided for predicate devices..." and "These modifications have no impact on the substantially equivalence between the subject devices and the predicate devices in terms of indications and design for the following technological characteristics: • Indications • Labelling (labels) • Design • Raw materials • Packaging • Biocompatibility • Stability • Sterilization".

However, the document does mention some performance data for trocar compatibility as part of continuous improvement initiatives related to the updated IFUs. This is a very specific type of bench test, not a clinical study on reader performance or standalone algorithm performance.

Here's a breakdown of what information can be extracted or inferred from the provided text, and what cannot based on the nature of this particular 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria or detailed performance results for the trocar compatibility test. It only states that the devices met the criteria.

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

• Test Set Sample Size: Not specified for the trocar compatibility bench test.
• Data Provenance: The document does not specify the country of origin for the bench test data. It is an in vitro (bench) test, not data from human subjects.

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

• Not applicable. The "ground truth" here pertains to the physical performance of the mesh with a trocar, which is evaluated through engineering/bench testing, not expert interpretation of clinical data.

4. Adjudication method for the test set

• Not applicable. This was an in vitro bench test, not a study requiring adjudication of expert opinions.

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 MRMC study was done. This submission is for surgical mesh, not an AI-powered diagnostic device.

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

• No standalone algorithm performance study was done. This submission is for surgical mesh, not an AI-powered device.

7. The type of ground truth used

• For the mentioned performance data (trocar compatibility): The ground truth would be the objective measurements and engineering standards applied during the in vitro bench testing.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm submission requiring training data.

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

• Not applicable. This is not an AI/algorithm submission requiring training data.

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PARIETEX™ Plug and Patch is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach.

PARIETEX™ Plug and Patch is a kit composed of:
• A pre-cut non absorbable patch made out of polyester monofilament.
• A semi-absorbable disk made from the assembly of two textile layers. This disk is composed of polyester monofilament and polylactic acid monofilament.

The provided document is a 510(k) summary for the PARIETEX™ Plug and Patch surgical mesh. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than conducting extensive clinical studies with specific performance metrics for acceptance criteria in the way a new drug or novel AI device would.

Based on the provided text, there is no detailed information about specific acceptance criteria or an analytical or clinical study designed to prove the device meets such criteria in terms of outcomes or effectiveness on patients. The submission relies on demonstrating technological characteristics equivalency and bench testing.

Therefore, I cannot fully complete all sections of your request as the information is not present in the provided text. However, I can extract what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for bench testing.
• Data Provenance: The "Performance Data" section mentions "Bench testing has been conducted," implying laboratory-based testing rather than clinical data from human subjects. No country of origin is specified for this testing. It is inherently retrospective in the sense that it's pre-market testing.

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

• Not applicable/Not mentioned. The evaluation is based on material properties and mechanical performance, not expert-adjudicated clinical outcomes.

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

• Not applicable/Not mentioned. No clinical adjudication 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:

• No, an MRMC comparative effectiveness study was not done. This is a medical device (surgical mesh), not an AI diagnostic or assistance tool.

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 is a physical medical device.

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

• For biocompatibility: Adherence to ISO 10993-1 and/or USP standards.
• For technological characteristics: Direct comparison to predicate device specifications (e.g., materials, knitted structure).
• For performance characteristics: Results from bench testing (likely mechanical strength, tear resistance, burst strength, etc., though specific metrics are not detailed). The "ground truth" here is the established mechanical properties of the predicate devices.

8. The sample size for the training set:

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

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

• Not applicable. This device does not use a "training set."

Summary of the Study Proving Acceptance Criteria:

The "study" described in this 510(k) summary is primarily focused on bench testing and demonstrating substantial equivalence to already legally marketed predicate devices. The submission indicates that:

• The PARIETEX™ Plug and Patch is made of biocompatible materials that comply with recognized standards (ISO 10993-1, USP).
• Its technological characteristics (e.g., construction from knitted polyester monofilament and polylactic acid) "are similar to those of the predicate devices."
• "Bench testing has been conducted to evaluate the performance characteristics" and has shown the device to be "equivalent in performance characteristics to the predicates PARIETEX™ Lightweight Monofilament Polyester Mesh, PARIETEX PROGRIP™ Mesh and BARD® Mesh PerFix® Plug."

The document does not detail the specific parameters or results of this bench testing, but the FDA's clearance implies satisfaction with this evidence for substantial equivalence. The "acceptance criteria" here are implicitly that the new device's material properties and mechanical performance attributes are within the acceptable range or "equivalent" to the established performance of the predicate devices.

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