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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.

• Material: Composed of 100% PTFE, a known biocompatible material used extensively in medical implants.
• Functionality: Non-resorbable, stiff enough to create space, and supple enough to be formed over defect margins, similar to predicate devices.
• Biocompatibility: PTFE has passed USP Class VI, carcinogenicity, and hemocompatibility studies, demonstrating non-reactivity to body fluids and tissues. |

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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