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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™ Hydrophilic 2D, 3D, Anatomical Mesh is intended for the repair of inguinal and incisional hernias.

Parietex™ Composite Mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The nonabsorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Parietex™ Optimized Composite Mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable threedimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh: 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 three-dimensional mesh (TET references) has hexagonal pores. The Parietex™ hydrophilic 2-dimensional mesh, hydrophilic 3-dimensional 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 preperitoneal 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 inguinal hernias via laparoscopic or posterior open procedures and is available for the left and/or right side.

Parietex™ Composite Mesh is a composite mesh made out of a three-dimensional (3D) multifilament polyester textile for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin, polyethylene glycol and glycerol and juts out 5 mm over the edge of the reinforcement. For some references, a bi-dimensional (2D) multifilament polyester textile flap is attached to the 3D reinforcement and helps place and fixate the mesh (PCO-OS references).

Parietex™ Optimized Composite Mesh is made out of a three-dimensional (3D) multifilament polyester for wall reinforcement, 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 and juts out 5 mm over the edge of the reinforcement. The film is essentially degraded in less than 1 month. For some references, a bi-dimensional (2D) multifilament polyester textile flap is attached to the three-dimensional reinforcement and helps place and fixates the mesh (PCO-OSX references). For some references, one or many non-absorbable color monofilaments are tied (pre-placed sutures) to the three-dimensional mesh (PCO-FX references).

This document is a 510(k) summary for a surgical mesh device, which describes its indications for use, device description, comparison to predicate devices, and performance data. However, it does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document describes a medical device clearance based on substantial equivalence to predicate devices, focusing on materials, design, and mechanical performance (bench testing) of surgical mesh. It explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This means there was no clinical study, human-in-the-loop study, or AI/ML model performance evaluation described in this document.

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Parietex™ lightweight mesh is indicated for inguinal and ventral hernia repair.
The PARIETEX™ Parastomal Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.
The Parietex™ composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non-absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
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. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Parietex™ Lightweight Mesh: Non-absorbable synthetic surgical mesh made of two-dimensional monofilament polyester knitting.
Parietex™ Composite Parastomal Mesh: PARIETEX™ Parastomal Mesh is made from a monofilament polyester fabric, covered with an absorbable hydrophilic film. The meshes are available in two different designs. Both are round in shape. The first design is made from a three-dimensional monofilament polyester fabric and has a circular opening in the center. It is completely covered on one side with an absorbable hydrophilic film made of collagen from porcine origin, polyethylene glycol and glycerol. The second design is made from a three dimensional monofilament polyester fabric with a twodimensional monofilament polyester central band. One side of the second design is completely covered with the hydrophilic film. On the opposite side, only the two dimensional central band is coated with the absorbable hydrophilic film. On both designs the film extends 5 mm over the external edge of the reinforcement, and also extends around the internal edge of the circular opening if any.
Parietex™ Composite Ventral Patch: The Parietex™ composite ventral patch is a dual facing mesh composed of a non-absorbable three dimensional monofilament polyester textile for abdominal wall reinforcement covered by a bioabsorbable hydrophilic collagen film to minimize visceral attachment. A fixation system composed of four (4) flaps made out of monofilament polyester textile and two (2) removable handles completes the device. This fixation system and the three-dimensional reinforcement textile are assembled with absorbable poly(divcolide-co-L-lactide) (PGLA) expanders. This system facilitates placement and fixation of the mesh. The fascial side of the mesh ensures abdominal wall reinforcement allowing complete tissue ingrowth. The visceral side of the mesh is composed of porcine origin collagen film, polyethylene glycol and glycerol. This film is absorbable, continuous and hydrophilic and juts out over the edge of the textile. This side physically separates the polyester textile from tissues and organs to minimize tissue attachment to the mesh in case of direct contact with viscera. The four (4) flaps of the Parietex™ composite ventral patch which provide a dedicated fixation surface area are composed of a dyed (D&C Green no. 6) bidimensional monofilament polyester textile. These flaps also facilitate visualization during the semi-peripheral suture fixation. Two (2) dyed (D&C Violet no. 2) PGLA expanders provide shape memory to the mesh and offer stability to facilitate insertion and proper deployment of the mesh through defect. The PGLA component is completely absorbed prior to one (1) year. The device also presents two (2) removable handles (composed of colored tubes and yarns) that are attached to the extremity of the flaps to provide a means for proper positioning of the mesh. They are kept extra corporally during the procedure and discarded after the surgery. The PGLA component and the hydrophilic film are fully absorbable which provide less long term foreign material in the body.
Symbotex™ Composite Mesh: 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): Non-absorbable 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 polyester textile flap is attached to the three-dimensional reinforcement and helps place and fix the mesh.

The provided document is a 510(k) summary for several surgical mesh products, indicating very limited information regarding acceptance criteria and detailed study results typical of clinical performance studies of AI/ML devices. The document focuses on demonstrating substantial equivalence to predicate devices primarily through bench testing, stability studies, and biocompatibility studies, rather than clinical performance or AI algorithm validation.

Here's a breakdown of the requested information based on the document, highlighting what is not available:

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

The document does not explicitly present acceptance criteria in a quantitative table with reported device performance for clinical endpoints. Instead, it refers to general performance characteristics and equivalence to predicate devices based on:

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

• Sample Size for Test Set: This information is not provided in the document. The studies referenced are bench testing, stability studies, and biocompatibility studies, which typically involve material samples or animal models, not human test sets in the context of clinical performance for AI/ML.
• Data Provenance: This information is not provided. The studies are technical in nature (bench, stability, biocompatibility).

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/not provided. The assessment for these surgical meshes relies on physical and biological testing, not on expert adjudication of diagnostic images or clinical assessments to establish ground truth for an AI/ML algorithm.

4. Adjudication method for the test set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies, particularly for diagnostic AI/ML. This document describes material science and biological compatibility 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

This information is not applicable/not provided. MRMC studies are relevant for evaluating diagnostic or assistive AI systems. The subject of this 510(k) is a surgical mesh with a change in raw material, not an AI device.

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

This information is not applicable/not provided. This device is a physical surgical mesh, not an algorithm.

7. The type of ground truth used

For the studies mentioned:

• Bench Testing: Ground truth is established by standardized measurements and tests of physical properties of the mesh following established FDA guidance for surgical mesh.
• Stability Studies: Ground truth relates to maintaining specified physical and chemical properties over time, measured through established analytical methods.
• Biocompatibility Studies: Ground truth is established by adherence to ISO 10993-1 standards, which involves evaluating biological responses to the material (e.g., cytotoxicity, irritation, sensitization, systemic toxicity), often using in vitro or in vivo (animal) models. They are not based on expert consensus, pathology in the clinical diagnostic sense, or patient outcomes data in this context for "ground truth".

8. The sample size for the training set

This information is not applicable/not provided. The document describes a material change for a physical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable/not provided. As above, there is no AI/ML algorithm with a training set.

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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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The PARIETEX™ composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non-absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Parietex™ Composite Ventral Patch is available as a round shape. It is a dual facing mesh composed of a non-absorbable three-dimensional monofilament polyester textile for abdominal wall reinforcement covered by a bioabsorbable hydrophilic collagen film to minimize visceral attachment. A fixation system composed of four flaps made out of a bidimensional monofilament polyester textile and two removable handles completes the device. This fixation system and the three-dimensional reinforcement textile are assembled with two poly(glycolide-co-L-lactide) (PGLA) expanders. This system facilitates placement and fixation of the mesh.

Here's a breakdown of the acceptance criteria and study information for the Parietex™ Composite Ventral Patch, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Parietex™ Composite Ventral Patch were primarily based on demonstrating substantial equivalence to its predicate devices: Parietex™ Composite Mesh (K040998) and Bard Ventralex® Patch (K021736 and K024008). The reported device performance confirmed this equivalence.

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

• Sample Size for Test Set: The specific numerical sample sizes for the bench testing (textile characterization, traction testing) and the in-vivo animal model are not explicitly stated in the provided summary.
• Data Provenance: The studies were conducted by Sofradim Production (a subsidiary of Covidien llc), which is located in France. The data appears to be retrospective as it was collected as part of a premarket notification application (510(k)) to demonstrate equivalence. The animal model study is preclinical.

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

• This information is not provided in the given 510(k) summary. The studies described are bench and preclinical (animal model) tests, which typically rely on objective measurements rather than human expert interpretation of images or clinical outcomes for their primary endpoints.

4. Adjudication Method for the Test Set

• This information is not applicable or not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies among experts. The studies here are bench and animal model tests.

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

• No, an MRMC comparative effectiveness study was not done. The studies focused on physical and biological equivalence to predicate devices using bench tests and an animal model, not on human reader performance with or without AI assistance.

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

• Not applicable. The device is a surgical mesh, not an algorithm or AI-powered system, so the concept of standalone algorithmic performance does not apply.

7. The Type of Ground Truth Used

The ground truth for the performance evaluations was established through:

• Objective Measurements: For textile mechanical performance and assembly tensile strength, the ground truth was derived from standardized bench testing measurements (e.g., tensile strength, material characterization).
• Preclinical In-vivo Observations: For collagen film performance (minimizing tissue attachment), the ground truth was based on observations and measurements from a representative animal model, comparing the device to the predicate.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical surgical mesh and not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. As stated above, this device does not involve a training set for an algorithm.

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The PARIETEX™ Optimized Composite mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

The PARIETEX™ Optimized Composite Mesh is available in rectangular and round shape. This device is made out of a three dimensional multifilament polyester knit for wall reinforcement, 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, and juts out 5 mm over the edge of the reinforcement. A bi-dimensional multifilament polyester textile flap is attached to the threedimensional reinforcement.

The provided text describes a 510(k) summary for the PARIETEX™ Optimized Composite Mesh, which is a surgical mesh. The document focuses on demonstrating the substantial equivalence of the proposed device to previously marketed predicate devices (PARIETEX™ Composite Mesh).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define specific numerical acceptance criteria (e.g., minimum tensile strength, maximum adhesion score). Instead, it states that the device is "equivalent in performance characteristics" to its predicates and demonstrates "improved mechanical properties" and "equivalent in-vivo minimizing tissue attachment property".

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

The document mentions "pre-clinical study and bench testing" but does not explicitly state the sample sizes used for these tests. It doesn't specify if the data was retrospective or prospective, or the country of origin.

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

This information is not provided in the document. The studies performed are bench and pre-clinical tests, not human-read studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable, as the tests described are bench and pre-clinical, not involving human interpretation with adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The studies were pre-clinical and bench testing.

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

The device is a physical surgical mesh, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable in this context. The performance tests evaluate the physical properties and in-vivo behavior of the mesh itself.

7. The Type of Ground Truth Used

For the mechanical property improvement, the ground truth would likely be established through standardized engineering tests (e.g., tensile strength, burst strength) compliant with relevant ISO or ASTM standards. This is inherent in "bench testing".
For the minimizing tissue attachment property, the ground truth would be established through a pre-clinical in-vivo study, likely involving histological analysis and gross observation of tissue adhesion, comparing the new mesh to the predicate mesh in an animal model.

8. The Sample Size for the Training Set

Not applicable. The device is a surgical mesh with design modifications, not an AI/ML algorithm that requires a "training set". The "training" for the mesh is in its manufacturing process and design iterations based on testing.

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

Not applicable, as there is no "training set" in the context of this physical device.

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The PARIETEX™ Optimized Composite Mesh (PCO) is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

The PARIETEX™ Optimized Composite Mesh (PCO) is available in rectangular and round shape. This device is made out of a three-dimensional multifilament polyester knit for wall reinforcement, 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, and juts out 5 mm over the edge of the reinforcement.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the PARIETEX™ Optimized Composite Mesh, structured to answer your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K110812) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance against those criteria as would be found in a full study report.

However, based on the text, we can infer the key performance areas and the general findings:

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

The document does not specify the exact sample sizes used for the "bench testing" and "pre-clinical study." It only states that these tests were performed:

• Sample Size: Not specified.
• Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective. "Pre-clinical study" typically implies animal studies or in-vitro tests, which are prospective. "Bench testing" is in-vitro.

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 and is not provided in a 510(k) summary for a surgical mesh. The testing performed involves objective measurements (mechanical properties, tissue attachment) rather than subjective assessments requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The listed studies (bench testing, pre-clinical study) are objective tests, not subjective assessments requiring 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

An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation by human readers, and the PARIETEX™ Optimized Composite Mesh is a surgical implant. There is no AI component mentioned or human-in-the-loop performance.

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

A standalone algorithm performance study was not done. This is not an AI/software device. The performance studies are for the physical properties and biological interaction of the surgical mesh.

7. The Type of Ground Truth Used

For the studies mentioned:

• Bench Testing: The ground truth would be based on objective physical measurements (e.g., tensile strength, burst strength, tear resistance) performed according to established test methods and standards (likely related to "Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh").
• Pre-clinical Study: The ground truth for "minimizing tissue attachment property" would likely be derived from histological examination or macroscopic assessment of tissue ingrowth/adhesion in animal models, comparing the new device to the predicate. The "ground truth" here is the scientific observation and measurement of biological response to the implanted material.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device that requires a training set. The "design modifications" (new collagen film formulation, changes to knitting) were likely the result of R&D and engineering design cycles, potentially using iterative testing, but not in the sense of a machine learning training set.

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

This information is 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™ TEM2015G and TEM3015G are rectangular meshes made of knitted monofilament polyester with polylactic acid (PLA) resorbable pins on one of the sides. The PLA pins facilitate placement, positioning and fixation of the mesh to the surrounding tissue.

The provided document is a 510(k) summary for the Parietex Progrip™ Mesh, specifically for new sizes TEM2015G and TEM3015G. It states that these new sizes are substantially equivalent to a previously cleared predicate device (K081050).

Based on the provided information, the document does not contain a study that proves the device meets specific acceptance criteria in the traditional sense of a clinical or performance study with defined metrics for the device itself.

Instead, this 510(k) submission relies on the concept of substantial equivalence to a predicate device. This means that the new device sizes are considered safe and effective because they are fundamentally similar to a device already legally marketed.

Here's a breakdown of why a table of acceptance criteria and reported device performance isn't applicable in the way you've requested, and how to address the other points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The 510(k) summary explicitly states:

• "No additional bench testing has been conducted."
• "The materials of the new Parietex Progrip™ references are identical to the predicate Parietex Progrip™ and therefore, the performance data submitted in the predicate Parietex Progrip™ Traditional 510k (K081050) applies to the two additional sizes."

This indicates that specific acceptance criteria and performance data for the new device sizes (TEM2015G and TEM3015G) were not generated independently. Their performance is inferred from the predicate device (K081050), which would have had its own performance data and acceptance criteria at the time of its clearance. Without the K081050 document, we cannot construct such a table for these specific acceptance criteria and performance results directly from this text.

Regarding the requested study information:

Since no new study was conducted for TEM2015G and TEM3015G, most of the following points are not applicable or cannot be determined from the provided text for these specific device sizes. The information below pertains to the absence of such studies for this 510(k) submission.

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

• Not applicable for this 510(k). No new test set data was generated. The submission relies on data from the predicate device.

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 for this 510(k). As no new test set was generated, there was no need for expert ground truth establishment for this submission.

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

• Not applicable for this 510(k). No new test set was generated.

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-assisted 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 (expert consensus, pathology, outcomes data, etc)

• Not applicable for this 510(k). No new ground truth for performance was established for the new device sizes.

8. The sample size for the training set

• Not applicable. This device is a surgical mesh; the concept of a "training set" is not relevant in this context.

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

• Not applicable. This device is a surgical mesh.

Summary of what can be derived from the document:

• Device: Parietex Progrip™ Mesh (TEM2015G and TEM3015G)
• Indication: Inguinal and incisional hernia repair.
• Mechanism of Clearance: Substantial Equivalence to predicate device Parietex Progrip™ Mesh (K081050).
• Reason for Substantial Equivalence: The new sizes are comprised of identical materials and share the same intended use and fundamental technology as the predicate device. No new performance or testing data was required or submitted for these specific models, as the performance data from the predicate device's 510(k) (K081050) was deemed applicable.

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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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The Parietex™ Monofilament Polyester Mesh is indicated for inguinal and ventral hernia repair.

PARIETEX™ - Monofilament Polyester Mesh is made out of a non-absorbable bi-dimensional monofilament polyester knitting and is available in rectangular shape.

This document is a 510(k) summary for a medical device called PARIETEX™ - Monofilament Polyester Mesh. It describes the device and its intended use, but it does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in terms of diagnostic accuracy or AI performance.

The "Performance Data" section states: "Bench testing has been conducted to evaluate the performance characteristics of PARIETEX™ - Monofilament Polyester Mesh. Testing has shown that the PARIETEX™ - Monofilament Polyester Mesh is similar in performance characteristics to the predicate MERSILENE™."

This indicates a comparison was made to a predicate device, but it's focused on the material's performance characteristics through bench testing, not a study evaluating diagnostic accuracy or a specific set of acceptance criteria for an AI/algorithm-driven device.

Therefore, the requested information for an AI/algorithm-focused study cannot be extracted from this document.

Based on the provided document, the following cannot be answered:

1. A table of acceptance criteria and the reported device performance: The document only mentions bench testing showing similarity in performance characteristics to a predicate device, but no specific quantitative acceptance criteria or reported values are given.
2. Sample size used for the test set and the data provenance: Not applicable as there is no study described that involves a "test set" in the context of an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this document pertains to a surgical mesh, not a diagnostic imaging or AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

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