(68 days)
Collagen Dental Membrane is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect or ridge augmentation to aid in wound healing post surgery.
The Collagen Dental Membrane is a resorbable, type I collagen matrix of defined geometry, in vivo stability, permeability and mechanical strength for use as a material to aid in wound healing in bone repair, ridge augmentation and dental implant procedures.
The device is provided in two sizes 20 mm x 30 mm x 40 mm. The device can be easily trimmed for a final fit during surgery to the appropriate size and shape required for the defect to be treated.
- A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Resorbable | Resorption time of 26 to 38 weeks in rat subcutaneous implantation model. |
| Biocompatible | Passed recommended FDA biocompatibility tests. |
| Cell occlusive | Designed to retard and/or prevent down growth of epithelium, and prevent contact of gingival connective tissue with implant and bony surface. |
| Clinically manageable | Designed for clinical manageability. |
| Suturable | Designed to be suturable. |
| Aid in wound healing | Demonstrated in animal and human studies (literature review). |
| Substantially equivalent to BioGide® | Concluded to be substantially equivalent. |
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Sample size used for the test set and the data provenance:
For the "Summary of In Vivo Resorption Studies," the study was conducted using a "rat subcutaneous implantation model." The specific number of rats or samples is not provided, nor is the country of origin. This was an animal study.
For the "Summary of Effectiveness Data" (Animal Data and Clinical Data), the information is derived from a "comprehensive literature search" and "results from human studies from the literature." No specific sample sizes for a single test set are provided, as this refers to aggregated literature. The provenance is from published animal and human studies. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The effectiveness data comes from a literature review of existing studies, not from a new test set with expert-established ground truth. Biocompatibility and in vivo resorption studies would typically involve laboratory analysis and histopathology, but no information on specific experts or their qualifications is provided in this summary. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. As noted above, the effectiveness data relies on a literature review, and the other studies (biocompatibility, in vivo resorption) are laboratory-based, not expert adjudication for a test set in the described manner. -
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 collagen dental membrane, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical material (collagen dental membrane), not an algorithm or AI system. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For "Summary of In Vivo Resorption Studies": The ground truth for resorption time would likely be established through histological examination of explanted tissues, potentially involving pathology.
- For "Summary of Effectiveness Data" (Animal and Clinical): The ground truth is derived from the established scientific literature on Guided Bone Regeneration (GBR), which would typically involve histological evidence of bone formation, clinical outcomes (e.g., implant integration, bone fill), and expert interpretation from those studies.
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The sample size for the training set:
Not applicable. This submission describes a physical medical device, not a machine learning model that requires a "training set." -
How the ground truth for the training set was established:
Not applicable, as this device does not involve a machine learning model with a training set.
§ 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.