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

TefGen-LS membrane is a 100% PTFE non-absorbable guided tissue membrane. The material is easily trimmed to a variety of shapes as required by specific cases.

This document is a 510(k) summary for the TefGen-LS™ Guided Tissue Membrane, a non-absorbable augmentation membrane used as a temporary space-making barrier over bone or other tissue.

Here's an analysis of the acceptance criteria and the study information provided:

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

The document does not explicitly state formal acceptance criteria with specific numerical targets (e.g., a certain percentage of success, or a specific range for a physiological measurement). Instead, the determination of substantial equivalence is the primary criterion.

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

The document primarily relies on literature review and biocompatibility testing to establish safety and efficacy for substantial equivalence. It does not describe a traditional "test set" in the context of a prospective, human clinical trial with a defined sample size for the TefGen-LS™ device itself.

• Test set for TefGen-LS™: Not explicitly described in terms of a specific number of human subjects or a defined dataset for performance evaluation. The evaluation is based on the established safety profile of PTFE and comparative technological characteristics.

• Data Provenance: The literature cited includes:

  • "Implant Dentistry" (1995)
  • "Oral Implantology" (1995)
  • IADR Annual Meeting (Singapore, 1995)
  • "Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology" (1996)
  • "Dental Implantology Update" (1996)
  • Clinical Research Associates Newsletter (1996)

  These publications suggest a mix of clinical reports (e.g., Bartee), animal models (e.g., Carr, Crump), and general clinical updates. The specific countries of origin for the studies in the cited literature are not provided, but the journals are generally international or US-based. These appear to be retrospective data from existing literature rather than new prospective studies specifically for TefGen-LS™.

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)

This section is not applicable as the submission relies on published literature and general biocompatibility testing of the material (PTFE), rather than a specific test set requiring expert ground truth for a novel performance metric of the TefGen-LS™ device itself. The "ground truth" here is the established scientific understanding of PTFE's properties and its performance in predicate devices as documented in the provided literature.

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

None is explicitly described. The evaluation is based on a review of existing scientific literature and technical comparisons.

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 device is a bone grafting material, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant to this submission.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

The "ground truth" used for establishing substantial equivalence primarily consists of:

• Literature-based evidence: Published clinical reports, animal studies, and general scientific understanding regarding the performance and safety of PTFE in similar medical applications, and specifically in augmentation membranes.
• Biocompatibility testing results: PTFE having passed USP Class VI, carcinogenicity, and hemocompatibility studies.
• Predicate device characteristics: Comparison to the established characteristics and performance of already marketed PTFE augmentation membranes (TefGen-FD and GORE-TEX).

8. The sample size for the training set

Not applicable. This is a physical medical device. It does not involve a "training set" in the context of machine learning.

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

Not applicable. As above, a training set is not relevant for this type of device submission.

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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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