(238 days)
GRAFTON® DBM is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON® DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON® DBM is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is resorbed/remodeled and is replaced by host bone during the healing process.
GRAFTON® DBM is a human bone allograft product containing human demineralized bone matrix (DBM) and an inert additive for intraoperative handling. It is intended to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. GRAFTON® DBM is provided ready-to-use in various physical forms. It is packaged in various sizes by volume or dimension for single patient use. GRAFTON® DBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary processing method of Osteotech, Inc. that has been validated to consistently produce DBM that is osteoinductive in an athymic rat assay.
This document describes a 510(k) premarket notification for the GRAFTON® DBM (Demineralized Bone Matrix) product. As such, it is not a study proving device meets acceptance criteria in the sense of a clinical trial for a novel AI device. Instead, it is a submission demonstrating substantial equivalence to legally marketed predicate devices, which is a different regulatory pathway.
Therefore, many of the typical questions regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and comparative effectiveness for AI devices are not applicable in this context. The document focuses on demonstrating that GRAFTON® DBM is as safe and effective as existing devices.
However, I can extract the relevant information from the provided text based on the closest applicable concepts:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are generally related to demonstrating substantial equivalence to predicate devices, focusing on materials, intended use, and performance characteristics (like osteoinductivity for DBM products). "Reported device performance" for DBMs typically refers to their biological properties.
| Acceptance Criterion (Implicit for DBM) | Reported Device Performance (GRAFTON® DBM) |
|---|---|
| Material Composition (Substantial Equivalence) | Contains human demineralized bone matrix (DBM) in a resorbable non-tissue additive or carrier, substantially equivalent to predicate devices. |
| Intended Use/Indications (Substantial Equivalence) | Intended to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects, consistent with predicate devices. |
| Osteoconductivity | Osteoconductive. |
| Osteoinductivity | Osteoinductive in an athymic rat assay. The proprietary processing method is validated to consistently produce osteoinductive DBM. Bone formation is scored on a five-point linear scale (0-4) at 28 days*. |
| Viral Inactivation | Proprietary production process validated to inactivate viruses including HIV-1, hepatitis B, hepatitis C, CMV, and Polio virus, further reducing disease transmission risk beyond donor screening. |
| Overall Performance (compared to predicates/alternatives) | The results of studies in animals and humans show that GRAFTON® DBM performs at least as well as, if not better than, predicate devices, autograft and/or demineralized bone matrix. (Note: Specific study details are not provided in this summary but are referenced as existing.) |
*Note on : The document explicitly states: "This bone forming activity exhibited by GRAFTON® DBM in this athymic rat surrogate assay should not be interpreted as a predictor of clinical performance." This highlights that while the assay demonstrates a biological characteristic, it's not a direct measure of clinical success.
2. Sample size used for the test set and the data provenance
For the osteoinductivity assay:
- Sample size: Not explicitly stated, but the method describes "ongoing testing of GRAFTON® DBM finished product for osteoinductivity in this validated athymic rat assay". This suggests a continuous testing process rather than a single fixed "test set" in the context of a clinical trial.
- Data provenance: Athymic rat model. This is an animal model, not human data. The specific country of origin is not mentioned, but the associated reference (Edwards et al., 1998) suggests US-based research. Retrospective/prospective is not directly applicable to an ongoing assay of a manufactured product.
For the statement "results of studies in animals and humans show that GRAFTON® DBM performs at least as well as...":
- Sample size: Not specified in this 510(k) summary. These would refer to existing, presumably published or unpublished, studies.
- Data provenance: Mention of "animals and humans" but no further detail on country of origin or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For the athymic rat assay: Ground truth (scoring of bone formation) would typically be established by trained laboratory personnel or pathologists specializing in histology. The number of experts and their specific qualifications are not detailed in this summary. The mention of a "five-point linear scale (0,1,2,3,4) to score bone formation" suggests a standardized, objective scoring method.
4. Adjudication method for the test set
- Not specified for the athymic rat assay, nor is it explicitly mentioned for any 'test set' in the context of a human clinical study. Given the nature of a 510(k) summary and the animal model, a formal multi-reader adjudication method as seen in complex clinical imaging trials is unlikely to be detailed here.
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
- No. This document describes a medical device (bone graft material), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a medical device, not an algorithm. This question is not applicable.
7. The type of ground truth used
- For the osteoinductivity evaluation: Histological assessment (scoring of bone formation on a five-point scale) in an athymic rat model, based on a validated assay. This is a surrogate marker for human clinical performance.
- For the broader claim of performing "at least as well as" predicates: This would implicitly rely on clinical outcomes data (e.g., fusion rates, healing rates) from animal and human studies, though specific details are not provided in this summary.
8. The sample size for the training set
- This concept is not applicable in the context of a 510(k) for a DBM product. There is no "training set" for an algorithm. The "proprietary processing method" is validated to consistently produce osteoinductive DBM, which implies quality control and process validation, not machine learning model training.
9. How the ground truth for the training set was established
- This question is not applicable for the reasons stated in point 8. The "ground truth" for ensuring consistent product quality (i.e., osteoinductivity) is established through the validated athymic rat assay as described in point 7.
§ 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.