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The device is indicated as a dura substitute for the repair of dura mater.

The proposed device is composed of bovine pericardium processed through a proprietary tissue preservation and sterilization process which includes gamma irradiation. The proposed device is composed of collagenous connective tissue with three-dimensional intertwined fibers and can be fixed regardless of the direction of the device. 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 proposed device in its unopened, undamaged package is sterile.

The provided document describes the K132850 submission for a Bovine Pericardium Suturable Dural Graft, Tutopatch™ DM Graft, or Tutoplast® Bovine Pericardium DM. The submission focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria with a specific study framework for entirely new performance standards.

Here's a breakdown based on the information provided, tailored to your request but highlighting the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission for substantial equivalence, "acceptance criteria" are typically defined by demonstrating performance comparable to legally marketed predicate devices, rather than predefined absolute thresholds for a novel device. The document uses predicate device performance as the benchmark for "substantial equivalence."

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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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Tutopatch bovine pericardium is intended for the reinforcement of tissue during general and plastic surgery repair. The labeling reveals that the applicant and all predicate devices have the same intended use as a general and plastic surgery surgical mesh.

Tutopatch bovine pericardium is intended for use to reinforce soft tissue where weakness exists in general and plastic surgery applications and is indicated 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, repair of rectal prolapse using an abdominal approach (excluding rectocele), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, ventral, scrotal, and umbilical).

Tutopatch bovine pericardium is a Tutoplast® Processed, solvent-dehydrated gamma irradiated preserved bovine pericardium surgical mesh. Tutopatch bovine pericardium 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 formulative structure to support replacement by new endogenous tissue. Tutopatch bovine pericardium is supplied in sterile double-packaged peelable pouches and comes in a variety of sizes.

Here's a summary of the acceptance criteria and the study information for the Tutopatch bovine pericardium device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The FDA submission for Tutopatch bovine pericardium does not define specific quantitative acceptance criteria in the provided text. Instead, it states that the device was evaluated against general performance standards for safety, biocompatibility, and mechanical strength. The reported performance indicates that the device met these general expectations.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that the device was "evaluated by a number of tests."

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

The provided text does not mention the use of experts to establish ground truth for a test set, nor does it refer to any clinical studies involving expert assessment. The evaluation appears to be based on laboratory and material property testing.

4. Adjudication Method for the Test Set

As there's no indication of a test set requiring expert ground truth or human assessment, an adjudication method is not applicable/not mentioned in the provided documentation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or mentioned in the provided documentation. The submission focuses on the material properties and processing of the surgical mesh rather than comparative clinical performance involving human readers or AI.

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

This is not applicable as the device is a physical surgical mesh, not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the evaluation of the Tutopatch bovine pericardium appears to be based on established material science principles, biocompatibility standards, and mechanical testing protocols as they apply to surgical mesh materials. The tests performed include assessments for safety, biocompatibility, toxicity, pyrogenicity, sterility, and mechanical strength. This is not a clinical "ground truth" derived from patient outcomes or expert consensus on diagnostic imaging.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical surgical mesh and not an AI or machine learning model that would require 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 AI or machine learning model.

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