(37 days)
Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filing of defects after root resection, apicocctomy, and cystectomy Filing of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regencration (GTR) and Guided Bone Regencration (GBR).
Filing of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are natural non-antigenic, porous bone mineral matrixes. They arc produced by removal of all organic components from bovinc bone. Due to its natural structure, BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are physically and chemically comparable to the mineralized matrix of human bone. It is available as cortical granules and blocks.
The provided text is a 510(k) summary for BIO-OSS devices. It states that the basis for substantial equivalence is that the devices are "substantially equivalent to Geistlich's existing products..." The only difference being an alternative geographic source for the bovine bone. The document “incorporates by reference all of the information on the use of BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen in the above referenced 510(k) submissions."
Therefore, the submission does not contain any new acceptance criteria or new study data proving the device meets acceptance criteria. Instead, it relies on the safety and effectiveness demonstrated in previous submissions for the predicate devices. This type of submission, focusing on a change in a non-critical aspect (like the source of raw material, with a demonstrated equivalent safety profile of the new source), typically references prior studies rather than conducting new ones.
Given the information provided in the input, I cannot answer the questions directly as the document does not present a new study with fresh acceptance criteria and device performance evaluation.
However, I can explain why the information isn't present based on the content:
- No new acceptance criteria or reported device performance: The submission is a 510(k) for a change in the bone source (from US to Australia) for an existing product. It claims substantial equivalence to predicate devices and incorporates by reference the information from those previous 510(k)s. This means no new performance criteria or new study results are presented in this specific document.
- No new sample size or data provenance for a test set: Since no new performance study is detailed, there's no new test set, sample size, or data provenance.
- No information on experts for ground truth or adjudication method: These details would be part of a new performance study, which is not included.
- No MRMC comparative effectiveness study: This type of study would be part of a clinical trial or performance evaluation, which is not present in this submission.
- No standalone performance (algorithm only) study: This implies the device is an algorithm or software, which is not the case for BIO-OSS, a bone filling material.
- No new ground truth type: No new ground truth is established as no new performance study is conducted.
- No new training set information: Similarly, no new training set details are provided.
- No new ground truth establishment for the training set: No new ground truth for a training set is established as no new study requiring one is described.
In summary, the provided 510(k) is an administrative update based on a change in raw material source for an already cleared device, not a submission detailing a new performance study.
§ 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.