(203 days)
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.
§ 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.