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Collagen Dental Membrane V 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.

Collagen Dental Membrane V is a white, nonfriable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from porcine dermis. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane V is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

The provided text is related to a 510(k) premarket notification for a medical device called "Collagen Dental Membrane V." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through clinical studies in the way a new drug or novel high-risk device might. The information requested aligns with the evaluation of AI/ML-driven medical devices, which often involve performance metrics, ground truth establishment, and clinical study designs.

However, the provided document does not contain the information requested for AI/ML device studies. This 510(k) summary focuses on the safety and substantial equivalence of a resorbable collagen membrane to existing predicate devices based on in vitro and animal studies, not on the performance of a diagnostic or assistive AI system.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study sizes, expert qualifications, adjudication methods, or MRMC studies for an AI/ML device, as this information is not present in the provided context.

The document indicates:

• Safety Evaluation: Collagen Dental Membrane V was evaluated in various in vitro and in vivo tests to assess its safety/biocompatibility. It passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing.
• Substantial Equivalence: The device is deemed "substantially equivalent" to predicate devices (Collagen Dental Membrane IV and Bio-Gide™ Resorbable Bilayer Membrane) based on similar intended use, form, animal source, sizes, thickness, physical integrity, permeability, and conformability, as well as the safety evaluation.

There is no mention of:

• Acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.)
• A "study" in the sense of a clinical trial proving a device meets specific performance criteria against a ground truth.
• Any sample sizes for test or training sets, as it's not an AI/ML product.
• Expert involvement for ground truth establishment.
• Adjudication methods.
• MRMC studies or human-in-the-loop performance.
• Stand-alone algorithm performance.
• Specific types of ground truth (pathology, outcomes data).

In summary, the provided text describes a submission for a traditional medical device (a resorbable collagen membrane) demonstrating safety and substantial equivalence to existing devices, not an AI/ML-driven device with performance criteria against a ground truth.

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