(184 days)
The Kensey Nash Fibrillar Collagen Dental Membrane is indicated for:
- . Simultaneous use of Guided Bone Regeneration (GBR)-membrane and implants.
- Augmentation around implants placed in immediate extraction sites. .
- . 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 Kensey Nash (KN) Fibrillar Collagen Dental Membrane is a translucent, resorbable, non-friable, rectangular collagen membrane sheet derived from bovine tissue. The KN Fibrillar Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.
The provided text is a 510(k) summary for the Kensey Nash Fibrillar Collagen Dental Membrane. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain any information about specific acceptance criteria or a study demonstrating the device meets those criteria.
The document states: "Performance Testing has confirmed that the Kensey Nash Fibrillar Collagen Dental Membrane is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics, pursuant to section 510(k)." This is a general statement and does not provide details of acceptance criteria or performance results.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details because this information is not present in the provided text.
The closest information provided is the list of predicate devices, implying that the new device's performance is compared to theirs for substantial equivalence, but the specific metrics and comparison results are absent.
§ 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.