(82 days)
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.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.