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This membrane is intended for use in oral surgical procedures as a resorbable material for augmentation around implants placed in immediate extraction sockets, augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation: alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

The TutoDent® Dental Membrane and CopiOs™ Pericardium Membrane are manufactured from bovine pericardium processed with the Tutoplast® process. These membranes are available in sizes ranging from 15 x 20mm to 30 x 40mm.

The provided text is a 510(k) summary for a medical device (TutoDent® Dental Membrane and CopiOs™ Pericardium Membrane) and the FDA's clearance letter. This type of regulatory document does not typically include detailed studies with acceptance criteria, sample sizes for test sets, ground truth establishment, or multi-reader multi-case studies as would be found in a clinical trial report for software or AI devices.

The core of this document is a claim of substantial equivalence to predicate devices, rather than a performance study against specific acceptance criteria. Therefore, most of the requested information regarding study design and performance metrics is not available in this document.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:

Acceptance Criteria and Device Performance Study (as described in the document):

The document does not explicitly define acceptance criteria as a table of thresholds for performance metrics. Instead, "acceptance" in this context refers to the FDA's determination of substantial equivalence to legally marketed predicate devices. The study proving this "acceptance" is the 510(k) premarket notification process itself, where the applicant demonstrates that the new device has the same intended use and similar technological characteristics to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. This document is a regulatory submission for substantial equivalence based on material and functional comparison, not a clinical performance study with a "test set" in the context of an AI device. There is no mention of a test set, its size, or its provenance.

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

• Not Applicable / Not Provided. Ground truth establishment by experts for a test set is not part of a 510(k) submission for this type of device. The "ground truth" for substantial equivalence is the existence and characteristics of the predicate devices already on the market.

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

• Not Applicable / Not Provided. There is no mention of a test set or an adjudication method. The FDA's review process is an adjudication of the submitted evidence by internal reviewers, but not in the context of a "test set" as typically understood for AI performance studies.

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

• No, a MRMC comparative effectiveness study was not done. This device is a resorbable membrane for oral surgery, not an AI-assisted diagnostic or imaging device. Therefore, the concept of "human readers improve with AI" is not relevant to this document.

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

• Not Applicable. This is a physical medical device (membrane), not an algorithm or software. Therefore, "standalone algorithm performance" is not relevant.

7. The type of ground truth used

• The "ground truth" for this 510(k) submission is the documented characteristics and regulatory status of the legally marketed predicate devices. The applicant is demonstrating that their new device is fundamentally similar to these existing, cleared devices.

8. The sample size for the training set

• Not Applicable / Not Provided. This is not an AI device, so there is no training set in the computational sense. The "training" for the substantial equivalence claim comes from the existing knowledge and data regarding the predicate devices.

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

• Not Applicable / Not Provided. As this is not an AI device, the concept of a training set and its ground truth establishment does not apply.

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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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