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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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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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