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Simultaneous use of GBR-membrane and implants
Augmentation around implants placed in immediate extraction sockets o
Augmentation around implants in delayed extraction sockets ●
Localized ridge augmentation for later implantation
Alveolar ridge reconstruction for prosthetic treatment ●
Filling of bone defects after root resection, cystectomy or removal of retained teeth
Guided bone regeneration in dehiscence defects and ●
Guided tissue regeneration procedures in periodontal defects. 0

Device Description

Collagen Dental Membrane - Conformable PP is a white, nonfriable, resorbable, single layered, conformable collagen membrane matrix manufactured from purified porcine peritoneum. Collagen Dental Membrane - Conformable PP is sterilized by gamma irradiation and is supplied sterile, non-pyrogenic and for single use only.

The collagen dental membrane has a thickness of approximately 0.1 to 0.8 mm and is available in the following sizes 12 x 25 mm. 15 x 20 mm, 25 x 25 mm, 20 x 30 mm, and 30 x 40 mm.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device called "Collagen Dental Membrane - Conformable PP". The purpose of this notification is to demonstrate substantial equivalence to legally marketed predicate devices, not typically to prove device performance against specific acceptance criteria in a clinical setting.

Therefore, the document does not contain information on acceptance criteria in the sense of predefined numerical thresholds for clinical performance metrics, nor does it describe a study specifically designed to establish such performance. Instead, it relies on demonstrating equivalence through non-clinical (bench and animal) testing and the existing clinical history of its predicate devices.

However, I can extract the information on the non-clinical tests performed. Please note that "acceptance criteria" here refers to the expected outcome of these non-clinical tests (e.g., non-cytotoxic, non-mutagenic), rather than clinical performance metrics.

Here is the information based on the document:

1. A table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria (Expected Outcome)	Reported Device Performance (Results)
Biocompatibility Testing
Cytotoxicity	Non-cytotoxic	Non-cytotoxic; No evidence of causing any cell lysis or toxicity.
Sensitization	No sensitization	No evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig test.
Intracutaneous Reactivity	No significant erythema or edema	Under the conditions of the study, there was no erythema or edema from the extract injected intracutaneously into rabbits. The test article extract met the requirements of the test since the difference between the mean score of the test extract and the corresponding control was passing.
Acute Systemic Toxicity	No mortality or systemic toxicity	No mortality or evidence of systemic toxicity.
Genotoxicity (Bacterial Reverse Mutation)	Non-mutagenic	Non-mutagenic to Salmonella typhimurium and to Escherichia coli strain WP2uvra.
Genotoxicity (Mouse Lymphoma Assay)	Non-mutagenic	None of the test article treatments induced substantial increases in the number of revertant colonies. Based on the criteria and conditions of the study protocol, the test article is considered non-mutagenic.
Pyrogenicity	Non-pyrogenic	Non-pyrogenic
Muscle Implantation	Non-irritant (or comparable to control)	The macroscopic reaction was not significant compared with the sponsor provided control article (bovine tendon collagen membrane) and not significant as compared to the negative control article (HDPE). Microscopically, the test article was classified as a nonirritant as compared to the sponsor provided control article and as a moderate irritant as compared to the negative control article.
Subchronic Toxicity	Minimum/no adverse tissue reaction	Minimum tissue reaction up to 24 weeks of implantation and no adverse tissue reaction to the host.
In vitro product characterization
Physical properties (Membrane thickness,	Similar to predicate devices	Evaluation performed to demonstrate substantial equivalence to predicate devices. (Specific numerical similarity not provided for each property, but implicitly met for SE.)
conformability, suture strength)
Physicochemical properties (Permeability,	Similar to predicate devices	Evaluation performed to demonstrate substantial equivalence to predicate devices. (Specific numerical similarity not provided for each property, but implicitly met for SE.)
hydrothermal transition temperature)
**In vivo animal studies (Stability, local	Similar to predicate devices	Conducted to evaluate in vivo stability and local tissue response to the subject device as compared to its predicate device (BioGide®). (Specific numerical or detailed findings of similarity are not provided in this summary, but the conclusion states that the animal study shows the device's safety and substantial equivalence).
tissue response)**
Viral Inactivation Studies	Virally safe	Performed to ensure the viral safety of the product. (Specific results not detailed, but the conclusion states safety was demonstrated.)

Regarding the other requested information:

Sample size used for the test set and the data provenance:
- Biocompatibility Testing: The "sample size" here refers to the number of animals or cells used in the specific tests.
  - Cytotoxicity: Not specified (in vitro cell culture).
  - Sensitization: Guinea Pig (number not specified).
  - Intracutaneous Reactivity: Rabbits (number not specified).
  - Acute Systemic Toxicity: Mice (number not specified).
  - Genotoxicity: Bacterial cultures (Salmonella typhimurium and Escherichia coli) and Mouse Lymphoma cells.
  - Pyrogenicity: Rabbits (number not specified).
  - Muscle Implantation: Rabbits (number not specified).
  - Subchronic Toxicity: Rat (number not specified).
- In vitro product characterization: Not applicable, as these are bench tests on device samples.
- In vivo animal studies: Rabbit intraoral model and rat subcutaneous model (number of animals not specified).
- Data Provenance: The studies are non-clinical (in vitro and animal studies) performed to support regulatory submission. The country of origin of the data is not specified but is implicitly from testing laboratories. These are prospective tests designed to evaluate the safety and characteristics of the new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are non-clinical studies. "Ground truth" in this context would be the objective results of the validated test methods, not expert consensus on interpretations of medical images or patient outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., imaging) by multiple readers. These are non-clinical, objective laboratory tests.
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 document pertains to a resorbable collagen dental membrane, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical dental membrane, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" is established by the defined and validated methodologies of the respective ISO 10993 standards, USP standards, or specific test protocols (e.g., observation of cell lysis for cytotoxicity, measurement of immune response for sensitization, histological examination for implantation studies).
The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable, for the same reason as above.

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