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DSM Biomedical Porcine Pericardium Dental Membrane is indicated for:

• simultaneous use of GBR-membrane and implants
• augmentation around implants placed in immediate extraction sockets
• augmentation around implants placed in delayed extraction sockets
• localized ridge augmentation for later implantation
• alveolar ridge reconstruction for prosthetic treatment
• filling of bone defects after root resection, cystectomy, removal of retained teeth
• guided bone regeneration in dehiscence defects
• guided tissue regeneration procedures in periodontal defects.

The DSM Biomedical Porcine Pericardium Dental Membrane is a resorbable porcine pericardium derived extracellular matrix barrier membrane for guided tissue and bone regeneration in dental applications. The device is manufactured using a standardized, controlled, multistage process. The origin of all animals is the United States of America. It is provided as a lyophilized sheet in sizes 15 mm x 25 mm, 20 mm x 30 mm, and 30 mm x 40 mm, which may be hydrated with saline or blood. It can be easily trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane is easily drapeable while maintaining suture tear resistance. It is supplied sterile by ethylene oxide and is for single use only.

The DSM Biomedical Porcine Pericardium Dental Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. Animal studies have shown that DSM Biomedical Porcine Pericardium Dental Membrane is resorbed within 2 to 9 weeks.

This document is a 510(k) summary for the DSM Biomedical Porcine Pericardium Dental Membrane, seeking substantial equivalence to a predicate device (Bio-Gide® K042197).
The provided text does not contain detailed acceptance criteria or a study design in the format typically used for evaluating the performance of AI/ML-based medical devices (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating the substantial equivalence of a physical medical device (a resorbable membrane) to a predicate device.

However, I can extract the relevant information from the document to answer your questions based on the type of device and study described.

Here's the breakdown of the "acceptance criteria" and "study" as presented in this context:

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

In the context of this 510(k), "acceptance criteria" are not reported as specific numerical thresholds for diagnostic performance. Instead, the acceptance criteria are implicitly that the subject device (DSM Biomedical Porcine Pericardium Dental Membrane) performs similarly or equivalently to the predicate device (Bio-Gide®) across various characteristics, including in vivo performance.

The reported device performance is that the subject device achieved similar new bone formation to the predicate device in an animal model, even with faster degradation.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set (In vivo animal study): "A canine intrabony defect animal study" was performed.
  • Sample Size: Not explicitly stated as a number of animals or defects.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but it is an in vivo animal study, which is prospective by nature. The origin of the animals for the device material itself is the "United States of America."

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)

• Ground Truth for In vivo Study: The ground truth for the animal study (new bone formation) was established through "histopathology evaluations."
  • Number of Experts: Not specified.
  • Qualifications of Experts: Not specified, but implied to be pathologists or histologists capable of evaluating tissue samples for new bone formation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified. It's likely that histopathology evaluations are conducted by a single qualified expert unless discrepancies arise, at which point an internal expert consensus or review might be employed.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical barrier membrane, not an AI/ML diagnostic software. The comparison was device-to-device (subject device vs. predicate device) in an animal model, not AI vs. human readers.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Ground Truth Type: For the in vivo animal study, the ground truth for evaluating new bone formation was established by histopathology evaluations.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "characterization" and "bench tests" are akin to pre-market testing for a physical product, not machine learning model training.

9. How the ground truth for the training set was established

• Training Set Ground Truth: Not applicable, as there is no training set for an AI/ML model for this device.

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