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Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. Specifically indicated for: Plastic and reconstructive surgery; Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadriceps, or other tendons.

Porcine Dermal Matrix is a prescription, sterile, single use, hydrated, non-crosslinked, r orcine skin that has both the epidermal and subdermal sides removed leaving only the dermis. The product is available in several sizes.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Biocompatibility per ISO 10993-1 (MEM Elution, Bacterial Mutagenicity, Acute Systemic Injection, Guinea Pig Maximization, Intracutaneous Reactivity, Materials Mediated Rabbit Pyrogen, Eight Week Intramuscular Implant, Thirteen Week Intramuscular Implant, Six-Month Intramuscular Implant)	The product met all of the stated requirements of each test.
   Safety and Effectiveness for Intended Use	Demonstrated through bench testing.
   Substantial Equivalence to Predicate Devices	Performance is substantially equivalent to the predicate devices.

2. Sample Size for Test Set and Data Provenance:

   • The document does not specify a distinct "test set" in the context of an AI/ML device. The testing described is bench testing and biocompatibility testing on the product itself, not a dataset of medical cases.
   • Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective) for a test set is not applicable to this device's evaluation.

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

   • This information is not applicable as the device is a surgical mesh, not an AI/ML diagnostic or prognostic tool that would require expert-established ground truth for case evaluation.

4. Adjudication Method for the Test Set:

   • This information is not applicable for the same reasons above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-assisted diagnostic tools where human performance is being compared with and without AI assistance. The Porcine Dermal Matrix is a physical surgical mesh.
   • Therefore, information on the effect size of human readers improving with AI vs. without AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • No, a standalone study in the context of an algorithm's performance was not done. The device is a physical product.

7. Type of Ground Truth Used:

   • The "ground truth" for this device's evaluation was based on bench testing results (demonstrating mechanical properties and performance) and biocompatibility testing results (demonstrating biological safety according to ISO standards). It's not based on expert consensus, pathology, or outcomes data in the way an AI/ML device would be assessed.

8. Sample Size for the Training Set:

   • This information is not applicable. The device is a physical product, not an AI/ML algorithm that undergoes a training phase with a dataset.

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

   • This information is not applicable for the same reasons as above.

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