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ARISTE AB Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The non-absorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surqical implantation.

ARISTE AB Mesh is intended for single patient one-time use only.

ARISTE AB Mesh is a non-resorbable sterile prosthesis designed to provide mechanical support for reconstruction of soft tissue deficiencies. The mesh is constructed of polypropylene fibers knitted together to form the mesh. The resulting structure is an implant which reinforces the tissue defect. The mesh is coated with a thiolene polymer. The coating acts as a carrier for antibiotic agents rifampin and minocycline in equal concentrations of approximately 171μg/cm² to help provide protection from bacterial colonization of the device during surgical implantation.

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as typically expected for an AI/ML device submission (e.g., performance metrics like sensitivity, specificity, accuracy, or AUC).

The document is a 510(k) clearance letter and summary for a surgical mesh (ARISTE AB Mesh), which is a physical medical device, not an AI/ML software device. The "performance testing" described refers to bench, animal, and biocompatibility testing for a physical implant, and the "acceptance criteria" for such devices are related to mechanical strength, biocompatibility, sterilization, and drug elution, rather than diagnostic accuracy or concordance with expert readers.

Therefore, I cannot provide the requested information in the format specific to AI/ML device evaluations.

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Is intended for the repair of hernias and other abdominal fascial deficioncies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. . Examples of applications where TyRx Surgical Mesh may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.

TyRx Surgical Mesh is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. TyRx Surgical Mesh is constructed of a non-resorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh. The resorbable coating represents approximately 10% of the total weight of the device. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue.

This document describes a 510(k) premarket notification for a new surgical mesh and does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics in the way a diagnostic algorithm or AI device submission would. The submission focuses on demonstrating substantial equivalence to predicate devices for its intended use.

However, I can extract the relevant information that is available and indicate when specific details are not provided in the document.

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

Based on the provided text, specific numerical acceptance criteria and corresponding performance values for the TyRx Surgical Mesh are not explicitly stated in terms of a table with quantitative metrics. The submission focuses on demonstrating comparability and biocompatibility.

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

• Test Set Sample Size: The document only mentions "animal testing" and "non-clinical laboratory testing." It does not specify the sample size (number of animals or test replicates) for either of these.
• Data Provenance: The document does not specify the country of origin of the data. It indicates the company is based in Monmouth Junction, NJ, USA, but this doesn't confirm where the testing took place. The testing was "non-clinical laboratory testing" and "animal testing," which are typically considered prospective in nature for evaluating a new device.

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

The document mentions "histopathology" for evaluating tissue ingrowth. This implies expert assessment. However, the number of experts and their specific qualifications (e.g., "veterinary pathologist with 10 years of experience") are not specified in the provided text.

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

The document does not provide any information regarding an adjudication method for establishing ground truth or evaluating the test results.

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

• MRMC Study Done? No. This device is a surgical mesh, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study as described (human readers with/without AI assistance) is not applicable and was not performed.

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

• Standalone Performance? No. This device is a physical surgical mesh, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable and was not performed.

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

For the animal testing evaluating tissue ingrowth, the ground truth was established through histopathology, which typically involves examination and interpretation by a pathologist.

8. The sample size for the training set

This is not applicable as the device is a physical surgical mesh and not an algorithm that requires a training set.

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

This is not applicable as the device is a physical surgical mesh and not an algorithm that requires a training set.

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