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TefGen is an implant material which is intended to be used as a temporary space making barrier over bone or other tissue.

TefGen non-reinforced (TefGen-FD) and TefGen reinforced (TefGen-RE) membranes are 100% PTFE non-absorbable guided tissue membranes.

The provided document is a 510(k) premarket notification summary for the "TefGen Guided Tissue Membrane." It asserts substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly available in this document.

Here's an attempt to extract relevant information and note what is missing:

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

This document does not present quantitative acceptance criteria or detailed performance data from a specific study designed to meet those criteria. The submission focuses on demonstrating substantial equivalence primarily through material composition and intended use, supported by existing literature on PTFE and general biocompatibility.

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

Not applicable. The document does not describe a "test set" in the context of a performance study for the TefGen device itself. It references existing literature and general biocompatibility testing of PTFE.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no specific clinical study with a "test set" and expert ground truth establishment is described for the TefGen device's performance.

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 a medical device for tissue regeneration, not an AI-assisted diagnostic tool.

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

Not applicable.

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

Not explicitly stated for the TefGen device itself in a dedicated study. The document relies on:

• Biocompatibility assays: USP Class VI, carcinogenicity studies, hemocompatibility studies (for PTFE as a material).
• Literature findings: Clinical reports and studies on high-density PTFE membranes for osseous defects and osteogenesis. These studies would have their own ground truths (e.g., histology, clinical outcomes, radiographic assessment), but those specifics are not detailed here for the TefGen device.

8. The sample size for the training set

Not applicable, as this is not a machine learning or AI device.

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

Not applicable.

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