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The device 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 membranes. 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 device is intended for single patient use only.

The proposed device is an implantable surgical mesh comprised of non-crosslinked porcine dermis that has been processed, terminally sterilized and is stored hydrated and ready to use. The proposed device is designed to perform as a scaffold that allows for neovascularization and permits replacement of the device with host tissue. The device in its unopened, undamaged package is sterile.

The provided text describes a 510(k) summary for a surgical mesh device, Fortiva™ porcine dermis / Tutoplast® porcine dermis, which focuses on establishing substantial equivalence to a predicate device (Strattice®). The document does not outline specific acceptance criteria in a quantitative sense (e.g., a target sensitivity or specificity for a diagnostic device) or provide a study that explicitly demonstrates the device "meets" such criteria for clinical performance.

Instead, the performance data presented is focused on demonstrating equivalence to a predicate device through various in vitro and in vivo tests related to biomechanical properties, manufacturing process safety, and biocompatibility.

Here's a breakdown based on the information provided, addressing your specific points:

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

The document does not provide a formal table of quantitative acceptance criteria for clinical performance or any metrics like sensitivity, specificity, or AUC. Instead, it describes equivalence-based performance criteria:

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

The document mentions an "implantation study" (animal study) but does not provide a specific sample size for this or any other test set. It does not mention the country of origin of the data. The study appears to be prospective in nature, as it describes evaluations conducted for the purpose of the 510(k submission.

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

Not applicable. This device is a surgical mesh, not a diagnostic AI system predicting outcomes. Ground truth in this context would likely refer to objective measurements and observations in the animal study rather than expert consensus on images or other diagnostic data.

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

Not applicable.

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 is not an AI-powered diagnostic device.

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

Not applicable. This is not an AI-powered diagnostic device.

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

For the biomechanical properties, the ground truth would be objective measurements from laboratory tests (tensile testers, burst strength testers, etc.).
For viral inactivation, the ground truth would be laboratory assays measuring viral titers after processing.
For pyrogenicity, the ground truth would be a validated rabbit pyrogen test result and endotoxin levels measured by specific assays.
For the implantation study, the ground truth would be:
* Objective measurements: Maximum tensile strength at the graft-host interface, burst strength.
* Pathology: Clinical and gross pathology assessments (likely by veterinary pathologists).
* Observation: Local effects of implantation (observed by researchers/veterinarians).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses training sets.

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

Not applicable.

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This device is intended for implantation to repair, reinforce and/or supplement soft tissue. This device is indicated for use in general and plastic surgery applications. This device is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include but are not limited to: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including but not limited to diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

These are borne pericardium surgical mesh devices processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. These devices consist of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, they have multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retain the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue.

This document focuses on the 510(k) summary for RTI Biologics, Inc.'s TUTOMESH® and TUTOPATCH® surgical mesh devices. The provided text is a regulatory filing asserting substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria through performance data.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including details like sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information, cannot be extracted from this document, as it does not contain such a study.

The document primarily states:

• Substantial Equivalence: The proposed devices are substantially equivalent to predicate devices in materials, design, function, intended use, and fundamental scientific technology.
• Description: These are bovine pericardium surgical mesh devices, processed with the Tutoplast® solvent dehydration process and gamma irradiation, consisting of collagenous connective tissue with multidirectional fibers.
• Intended Use: Implantation to repair, reinforce, and/or supplement soft tissue in general and plastic surgery applications, including various types of hernia repair and reconstruction.
• Summary of Technological Characteristics: The proposed device has materials, design, and function equivalent to predicate devices.

The FDA's letter confirms their review and determination of substantial equivalence based on the provided information, allowing the device to be marketed. This regulatory process focuses on comparing a new device to existing legally marketed predicate devices, rather than requiring extensive clinical trials to establish new performance metrics against predefined acceptance criteria for novel technologies.

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These products are indicated for use in general and plastic surgery applications. These products are intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

TUTOMESH® is a bovine pericardium surgical mesh processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. The TUTOMESH® device consists of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, it has a multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue.

The provided text is a 510(k) summary for the TUTOMESH® surgical mesh device, which is a regulatory submission to the FDA. It does not contain a study that proves the device meets specific acceptance criteria.

Instead, it asserts substantial equivalence to predicate devices based on materials, design, function, intended use, and fundamental scientific technology. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. These elements are typically found in detailed clinical trial reports or performance testing documentation, which are not part of this 510(k) summary.

The summary focuses on:

• Device Name: TUTOMESH®
• Proprietary Names: TUTOMESH®
• Common Name: Surgical Mesh
• Product Code: 79 FTL, Orthopedics Panel (later updated to FTM, MFX)
• Regulation Number: 21 CFR 878.3300
• Regulation Name: Surgical mesh
• Device Description: Bovine pericardium surgical mesh processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. It is described as collagenous connective tissue with three-dimensional intertwined fibers, offering multidirectional mechanical strength and supporting replacement by new endogenous tissue.
• Intended Use: General and plastic surgery applications, including repair of pericardial structures and as a prosthesis for surgical repair of soft tissue deficiencies like gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, pelvic floor reconstruction, and various hernias.
• Substantial Equivalence Claim: The device is claimed to be substantially equivalent to predicate devices in materials, design, function, intended use, and fundamental scientific technology.
• Regulatory Decision: The FDA determined the device to be substantially equivalent, permitting it to be marketed.

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