(261 days)
GENOSS Collagen Membrane is intended to be used during guided bone and guided tissue regeneration procedures as a biodegradable barrier membrane into bony defects surrounding teeth and on alveolar ridges.
- Periodontal/infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Guided bone regeneration (GBR) procedures
- Sinus lifts
GENOSS Collagen Membrane is a resorbable membrane to aid the regenerative healing of bone or bone/periodontal ligament defects of the oral cavity. GENOSS Collagen Membrane is designed to be a passive barrier which excludes epithelial and gingival connective tissue from the defect site so that only the desirable cells repopulate the space, allowing regeneration to occur. Its resorbability eliminates the need for a second surgery. GENOSS Collagen Membrane is made from bovine tendon, the Type 1 collagen and is sterilized in gamma-radiation.
The provided document, a 510(k) summary for the "GENOSS Collagen Membrane," describes the device, its intended use, and a series of performance tests to demonstrate its substantial equivalence to predicate devices. However, this document does not contain acceptance criteria for specific performance metrics in a quantitative sense, nor does it detail a study that proves the device meets such criteria within the typical framework of an AI/software device evaluation.
Instead, the document focuses on biocompatibility testing and in-vitro performance bench testing for a medical device (collagen membrane) used in dental procedures. The "acceptance criteria" are implied to be the successful completion of these tests with results indicating non-toxicity, non-sensitization, and meeting "established specifications necessary for consistent performance according to its intended use."
The information requested for AI device evaluations, such as sample sizes for test and training sets, data provenance, ground truth establishment by experts, and MRMC studies, are not applicable to this type of medical device (collagen membrane) and the information provided in this 510(k) submission. This is a premarket notification for a physical resorbable barrier membrane, not an AI or software-as-a-medical-device (SaMD) product.
Therefore, the following table and explanations are adapted to the context of the provided document, highlighting what is reported rather than what would be expected for an AI device.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit, quantitative acceptance criteria are not stated for this physical medical device in the document, the table below summarizes the types of tests performed and the general performance outcome reported. The acceptance criteria are broadly implied as "meeting established specifications" or "non-toxic and non-sensitizing."
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | - ISO Cytotoxicity: Completed, non-toxic |
| - ISO Systemic toxicity: Completed, non-toxic | |
| - ISO Pyrogenicity: Completed, non-pyrogenic | |
| - ISO Sensitization: Completed, non-sensitizing | |
| - ISO Intracutaneous reactivity: Completed, non-reactive | |
| - ISO Implantation: Completed, biocompatible to tissue | |
| - ISO Genotoxicity (Ames): Completed, non-genotoxic | |
| - ISO Genotoxicity (Micro-nucleus): Completed, non-genotoxic | |
| - ISO Haemocompatibility: Completed, haemocompatible | |
| - ISO Elution assay: Completed, non-toxic eluates | |
| - ISO Genotoxicity (Sister chromatid): Completed, non-genotoxic | |
| In-vitro Performance | - Shrink temperature (DSC): Evaluated, met specifications |
| - Tensile strength: Evaluated, met specifications | |
| - Decomposition time: Evaluated, met specifications | |
| - Swelling: Evaluated, met specifications | |
| Raw Material Safety | - Virus inactivation: Evaluated in accordance with ASTM F2212-08, confirmed safety |
| - Endotoxin: Evaluated in accordance with ASTM F2212-08, confirmed safety | |
| - Amino acid analysis: Evaluated in accordance with ASTM F2212-08, confirmed safety | |
| - SDS-PAGE: Evaluated in accordance with ASTM F2212-08, confirmed safety | |
| Overall Conclusion | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the GENOSS Collagen Membrane met the established specifications necessary for consistent performance according to its intended use." |
Study Details (as applicable to a physical medical device submission):
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Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for the biocompatibility or in-vitro performance tests. These tests are typically performed on a statistically relevant number of samples to ensure reproducibility and reliability, but the exact number isn't reported in the summary.
- Data provenance: Not explicitly stated, meaning no country of origin or whether it's retrospective/prospective data as these concepts are generally confined to clinical studies or data-driven AI models rather than benchtop testing of material properties. The tests were likely conducted in a controlled laboratory environment by the manufacturer or a contract research organization.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of expert consensus is typically relevant for diagnostic AI algorithms. For a physical medical device like a collagen membrane, the "truth" is established through standardized laboratory tests (e.g., ISO standards for biocompatibility, ASTM for material properties) which have defined methods and measurable outcomes, rather than expert interpretation of a diagnostic finding.
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Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers/experts when establishing ground truth for diagnostic classifications. This is not relevant for the bench and biocompatibility testing of a physical membrane.
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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 submission is for a physical medical device (collagen membrane), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission is for a physical medical device, not an algorithm.
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The type of ground truth used:
- The "ground truth" for this device's performance is based on objective, standardized laboratory measurements and observations as defined by ISO and ASTM standards (e.g., cell viability in cytotoxicity tests, temperature readings for shrink temperature, chemical composition analysis, etc.). It is not based on expert consensus, pathology, or outcomes data in the sense typically discussed for AI devices.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI algorithm, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
§ 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.