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Collagen Dental Membrane - Conformable IIBP is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Device Description

Collagen Dental Membrane - Conformable IIBP is a non-friable, resorbable membrane matrix consisting of purified intact collagen tissue derived from bovine pericardium. The membrane device is flexible and conforms to the contours of the defect site. Collagen Dental Membrane - Conformable IIBP is supplied pre-hydrated, sterile, non-pyrogenic, and for single use only.

The collagen dental membrane has a thickness of approximately 0.3 to 1.0 mm and is available in the following sizes 15 x 20 mm, 20 x 30 mm, and 30 x 40 mm.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for the device's efficacy or performance in its intended use (e.g., successful bone regeneration rate). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices by comparing technical characteristics and showing safety (biocompatibility).

The closest we can get to acceptance criteria in the context of this document are the results of the nonclinical tests which demonstrate the device performs as expected for a medical implant and is safe.

Acceptance Criteria (Inferred)	Reported Device Performance (Collagen Dental Membrane - Conformable IIBP)
Material Properties:
- Intact purified collagen tissue (Material)	Intact purified collagen tissue
- Bovine pericardium (Collagen Source)	Bovine pericardium
- Membrane form	Membrane
- White to off-white color	White to off-white
- Non-friable (Physical Integrity)	Non-friable
- Available in sizes: 15x20mm, 20x30mm, 30x40mm	15x20mm, 20x30mm, 30x40mm
- Approx. 0.5 mm thickness (Note: document states approx. 0.3 to 1.0 mm earlier, but 0.5 mm in table)	Approx. 0.5 mm
- Conformable to defect site	Conformable to defect site
- Can be sutured (Suture Strength)	Can be sutured
- Semi-permeable; permeable to nutrients and macromolecules (Porosity)	Semi-permeable; permeable to nutrients and macromolecules
- Cross-linked (Yes)	Yes (Proprietary method)
- Gradual resorption, resorbed in approx. 16 weeks (Resorption Time/In Vivo Stability)	Gradual resorption, resorbed in approximately 16 weeks as demonstrated in animal testing
Safety/Biocompatibility:
- Biocompatible	Biocompatible
- Non-cytotoxic	Non-cytotoxic. No evidence of causing any cell lysis or toxicity.
- Non-sensitizing	No evidence of sensitization was observed. Not considered a sensitizer.
- Non-intracutaneous reactive	No erythema and no edema from the test extract injected intracutaneously into rabbits.
- Non-systemically toxic	No mortality or evidence of systemic toxicity.
- Non-pyrogenic	Non-pyrogenic.
- Non-mutagenic (Genotoxicity - Mouse Lymphoma)	None of the test article treatments induced substantial increases in the number of revertant colonies. Considered non-mutagenic.
- Non-mutagenic (Genotoxicity - Ames Assay)	Non-mutagenic to Salmonella typhimurium strains TA97a, TA98, TA100, and TA1535 and to Escherichia coli strain WP2-uvrA.
- Minimum tissue reaction up to 4 weeks (Implantation)	Minimum tissue reaction up to 4 weeks of implantation and no adverse tissue reaction to the host.
- Minimum tissue reaction up to 24 weeks (Subchronic/Chronic Toxicity)	Minimum tissue reaction up to 24 weeks of implantation and no adverse tissue reaction to the host.
- Virally safe	Viral inactivation studies performed to ensure viral safety. (Specific results not detailed, but implied successful.)
Device Presentation:
- Pre-hydrated	Pre-hydrated
- Sterile, SAL 10-6	Sterile, SAL 10-6
- Single use only	Single use only
- Double peel package (Packaging)	Double peel package

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical tests (bench, in vitro, and animal studies) rather than a human clinical trial that would typically have a "test set" from a patient population.

Bench Tests (in vitro characterization): No specific sample sizes are provided for tests like membrane thickness, conformability, suture strength, permeability, or hydrothermal transition temperature.
Biocompatibility Studies (in vitro and in vivo):
- Cytotoxicity (ISO Agarose Overlay): Not specified.
- Sensitization (ISO Guinea Pig Maximization): Guinea pig. Number not specified.
- Intracutaneous Reactivity (Acute Intracutaneous in Rabbit): Rabbit. Number not specified.
- Acute Systemic Toxicity (ISO Systemic Toxicity in Mice): Mice. Number not specified.
- Pyrogenicity (USP Pyrogen Study – Material Mediated): Not specified (typically rabbit or LAL assay).
- Genotoxicity (In Vitro Mouse Lymphoma Assay): In vitro cell assay.
- Genotoxicity (Bacterial Mutagenicity Test - Ames Assay): In vitro bacterial assay.
- Implantation (Subcutaneous Implantation in Rats): Rats. Number not specified.
- Subchronic/Chronic Toxicity (Subcutaneous Implantation in Rats): Rats. Number not specified.
Animal Studies (in vivo stability and local tissue response):
- Rabbit intra-oral model: Rabbit. Number not specified.
- Rat subcutaneous model: Rat. Number not specified.
Viral Inactivation Studies: Not specified.

Data Provenance: The studies are non-clinical (laboratory and animal studies), so geographical provenance is not typically specified in the same way as human clinical data. The studies were performed to meet FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards, indicating international (ISO) and U.S. (FDA) regulatory guidelines. All studies appear to be prospective as they were specifically conducted for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to the non-clinical, non-human studies presented. Ground truth for the animal and in vitro tests would be established by the scientific methods and observations within the laboratory, not by expert consensus on interpretations of qualitative clinical data.

4. Adjudication Method for the Test Set

Not applicable as it's not a human clinical study requiring adjudication of expert interpretations.

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 approval involving a physical implantable membrane, not an AI or imaging diagnostic device.

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

Not applicable, as it's not an AI or algorithm-based device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical studies described, the "ground truth" is based on:

Laboratory measurements and assays: For physical, chemical, and in vitro biological properties (e.g., cytotoxicity, genotoxicity, permeability, thickness).
Histopathological examination and observation: For results from animal implantation studies (e.g., tissue reaction, resorption characteristics).
Validated test methods: Adherence to standards like ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in the context of this traditional medical device submission, as it's not an AI/machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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