(92 days)
NovaBonc-BBG - Resorbable Bone Graft Substitute is indicated to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/ maxillo-facial 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. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. NovaBone-BBG may be used alone in a manner comparable to autogenous hone graft 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. NovaBone-BBG is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
NovaBone-BBG is a synthetic resorbable ostcoconductive bone graft substitute composed of two similar calcium phospho-silicate bioactive glass materials. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects. The major component is a melt-derived calcium-phosphorus-sodiumsilicate (Bioglass) designed specifically for its absorbability and ostcoconductive nature. The second component is a calcium-phosphorus-silicate bioactive glass, chemically similar to the major component, but derived via a solution-gelation (sol-gel) process. The secondary sol-gel component is more rapidly absorbed from the graft site than the standard melt-derived component, opening additional space between the Bioglass particles for more rapid tissue infiltration and replacement by host bone during the healing process.
The provided document is a 510(k) Summary for NovaBone-BBG - Resorbable Bone Graft Substitute. It focuses on establishing substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study proving the device meets them in the way clinical studies for diagnostic or AI devices would.
Therefore, many of the requested points from your prompt cannot be directly extracted from this type of regulatory submission. The document emphasizes technological characteristics and intended use in comparison to existing devices.
However, I can extract information related to the comparison and the nature of the "study" mentioned, as well as the 'acceptance criteria' in the context of substantial equivalence.
Here's the breakdown of what can be inferred or directly stated from the document:
1. Table of Acceptance Criteria and Reported Device Performance
In the context of a 510(k) for a medical device like a bone graft substitute, "acceptance criteria" for demonstrating substantial equivalence are generally centered around similarity in:
- Intended Use: The new device should have the same intended use as legally marketed predicate devices.
- Technological Characteristics: The new device should have technological characteristics that are substantially equivalent to the predicate devices. Differences should not raise new questions of safety or effectiveness.
- Performance: The performance (e.g., biocompatibility, osteoconductivity, resorption profile) should be comparable to the predicate device.
The document discusses these aspects to support substantial equivalence.
| Acceptance Criteria (for Substantial Equivalence to Predicates) | Reported Device Performance (NovaBone-BBG) |
|---|---|
| Intended Use: (Similar to Predicates) | NovaBone-BBG is indicated for filling and/or augmenting dental intraosseous, oral, and cranio-/maxillofacial defects, similar to predicates. It resorbs and is replaced by bone. Can be used alone or mixed with allograft/autograft. |
| Technological Characteristics: (Similar to Predicates) | NovaBone-BBG, PerioGlas, and Biogran are all osteoconductive, space-filling particulates, synthetic, inorganic, biocompatible. NovaBone-BBG contains Bioglass and a sol-gel derived bioactive glass. The sol-gel component's faster absorption is highlighted as a technological difference but is presented as an improvement in absorption rate rather than a safety concern. |
| In Vivo Performance: (Comparable to Predicates) | "In vivo performance data comparing NovaBone-BBG and/or the individual sol-gel component to PerioGlas are summarized." (No specific quantitative metrics or formal acceptance thresholds are provided in this summary, but the conclusion states "side-by-side comparative in vivo performance data were presented" to show equivalence). |
| Material Composition: (Similar to Predicates) | Major component is melt-derived calcium-phosphorus-sodium-silicate (Bioglass). Second component is calcium-phosphorus-silicate bioactive glass (sol-gel derived), similar to Bioglass but without sodium. Both are calcium phospho-silicate bioactive glass materials. |
| Resorption Profile: (Comparable to Predicates) | "Essentially absorbed within the six-month timeframe normally associated with bone remodeling, the devices being replaced by new bone tissue." The sol-gel phase is "more soluble" and allows "more rapid initial absorption." |
| Warnings/Precautions: (Similar to Predicates) | "NovaBone-BBG does not possess sufficient mechanical strength to support load bearing defects prior to soft and hard tissue ingrowth." (Implies similar mechanical limitations to other bone graft substitutes lacking structural support). |
| Complications: (Similar to Predicates) | "Possible complications are the same as to be expected of autogenous bone grafting procedures." (Lists wound infection, delayed union, loss of reduction, failure of fusion, etc., implying a similar risk profile to existing methods/materials.) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified in the provided summary. The phrase "In vivo performance data comparing NovaBone-BBG and/or the individual sol-gel component to PerioGlas are summarized" indicates a study was performed without providing details on the number of subjects or cases.
- Data Provenance: Not specified. It's an "in vivo" study, which suggests it could be animal or human, but details like country of origin or retrospective/prospective nature are not in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not applicable and not provided. The study is about comparing the biological performance of a graft material, not about expert assessment of diagnostic images or clinical interpretations. "Ground truth" would refer to biological outcomes (e.g., new bone formation, graft resorption) which are typically assessed via histology or imaging, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
- Not applicable and not provided for this type of device submission. Adjudication methods like 2+1 or 3+1 are typically for reconciling differences in expert interpretations, which is not the nature of the studies discussed 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
- Not applicable. This is a bone graft material, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a bone graft material, not an AI or diagnostic imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "in vivo performance data" likely involved histological analysis of harvested tissue, imaging (e.g., radiographs, microCT), and/or gross observation of the graft sites to assess parameters like new bone formation, graft resorption, and integration. While not explicitly stated, "pathology" or similar biological outcomes data would be the closest analogue to "ground truth" for this kind of study.
8. The sample size for the training set
- Not applicable. This is a medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. This is a medical device, not a machine learning algorithm.
In summary: The provided document is a 510(k) summary, which is a regulatory document to demonstrate substantial equivalence to existing devices. It focuses on comparing the technological characteristics, intended use, and general performance observations, rather than a detailed report of a clinical efficacy study with specific acceptance criteria and ground truth validation as would be expected for a diagnostic or AI-driven device. The "study" mentioned is an "in vivo performance data" comparison to a predicate device, aiming to show similar biological behavior.
§ 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.