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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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Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies: this includes but is not limited to the following:

Buttressing and reinforcing staple lines during lung resection (e.g., wedge lobectomy, bullectomy, bronchial resection, blebectomy, resection, segmentectorny, pnuemonectorny, pneumoreduction) and other incision and excision of the lung and bronchus.

Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical).

Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.

An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas® Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.

The provided text does not contain a table of acceptance criteria or specific performance metrics of the device as would typically be found in a formal study. Instead, it describes a 510(k) Premarket Notification for the Veritas® Collagen Matrix, which asserts substantial equivalence to previously marketed predicate devices.

However, based on the provided text, we can infer some information relevant to the "acceptance criteria" through the lens of a substantial equivalence determination and the single study mentioned.

Here's an attempt to structure the information based on your request, highlighting what is present and what is not:

Acceptance Criteria and Device Performance for Veritas® Collagen Matrix

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The text only states "An animal study was conducted."
• Data Provenance: The study was an "animal study," implying pre-clinical data (not human clinical data). The location/country of origin is not specified. It is inherently prospective as it was conducted for this specific submission to evaluate the new indication.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not provided. As an animal study for a pre-market notification, the "ground truth" would likely be established by the researchers/veterinarians involved in the study, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided. Given that it's an animal study assessing physical characteristics (tissue attachment), formal adjudication methods like 2+1 or 3+1 are typically not applicable in the same way they would be for image-based diagnostic studies. The evaluation method would be part of the individual study's protocol.

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

• No, a MRMC comparative effectiveness study was not done. The study described is an animal study, not a human clinical trial involving multiple readers. Therefore, there is no effect size of human readers improving with AI assistance vs. without AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This document describes a physical medical device (surgical mesh), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here. The "standalone" performance here would refer to the device's functional characteristics in the animal model.

7. Type of Ground Truth Used

• The ground truth for the animal study (regarding tissue attachment) would be based on direct observation and histopathological analysis (implied) of the animal tissues post-implantation, assessing the degree of attachment. This would fall under direct scientific observation and potentially pathology.

8. Sample Size for the Training Set

• Not applicable/Not provided. This is a physical device, not an AI algorithm, so there is no "training set" in the machine learning sense. The device itself is "trained" through its manufacturing process and design based on prior knowledge and predicate devices.

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

• Not applicable. As above, there is no training set for an AI algorithm. For the development of the device itself (manufacturing, processing), ground truth is established through extensive material science testing, bio-compatibility studies, and prior pre-clinical/clinical data from its own previous iterations and predicate devices, ensuring it meets specified material properties and safety profiles. The specific animal study discussed was for a new indication, not for the fundamental development/training of the device itself.

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The UGYTEX Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

The UGYTEX Mesh is a surgical mesh used during open or laparoscopic procedures. The UGYTEX Mesh is made from polypropylene and a collagen based hydrogel component. The hydrophilic collagen film does not affect the physical performance characteristics of the mesh but serves to temporary separate the mesh from adjacent organs to minimize visceral attachment to the mesh, which may occur during the healing process. The UGYTEX Mesh is offered in several sizes and shapes to accommodate the type and approach of the operation.

The UGYTEX® Mesh 510(k) summary does not contain the detailed information necessary to complete all sections of your request comprehensively. Specifically, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study protocol for a novel device performance evaluation against specific acceptance criteria.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The provided 510(k) summary describes Performance Testing as the study undertaken to demonstrate the UGYTEX Mesh meets the acceptance criteria.

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

The document does not specify the sample sizes used for the performance testing. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). Based on the nature of a 510(k) submission for a physical device, this testing would typically be prospective laboratory and possibly animal testing rather than human clinical trial data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and therefore not provided in this 510(k) summary. The performance testing described (biocompatibility, density, thickness, etc.) are objective physical and chemical tests, not evaluations requiring expert review of subjective data.

4. Adjudication Method

This information is not applicable and therefore not provided. Given the nature of the physical and chemical tests, an adjudication method for ground truth establishment is not relevant.

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 done. This type of study is typically associated with diagnostic imaging or clinical decision support AI devices, not with a surgical mesh. The submission focuses on the material's physical and biological properties.

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

Not Applicable. The UGYTEX® Mesh is a physical surgical implant, not an algorithm or AI device. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing cited was based on objective measurements and laboratory evaluations of the physical and material properties of the UGYTEX Mesh, compared against accepted standards for surgical meshes and/or the properties of the predicate devices. For biocompatibility, it would be based on established toxicology and biological evaluation standards.

8. The Sample Size for the Training Set

This information is not applicable. The UGYTEX® Mesh is a physical product, not a software algorithm that requires a "training set" in the context of machine learning.

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

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

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