(115 days)
The intended use of NovaBone Dental Morsels is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. It is used in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone). Typical uses include:
- · Periodontal / infrabony defects
- · Ridge augmentation (sinusotomy, osteotomy, cystectomy)
- (ridge maintenance/augmentation, sites implant preparation/ · Extraction placement)
- · Sinus lifts
- · Cystic cavities
- · Oral and maxillofacial augmentation
NovaBone Dental Morsels is an osteoconductive, bioactive, bone void filler device. The device is intended for dental intraosseous, oral, and maxillofacial bony defects. It is a one-component, resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate, fused into a bulk porous form having a multidirectional interconnected porosity. The device is supplied sterile, packaged in a disposable PET-G tray with heat-sealed lid. On implantation, NovaBone Dental Morsels undergoes a time-dependent surface modification, resulting in the formation of a calcium phosphate layer on the device surfaces. The device acts as a scaffold, with new bone infiltrating the porous structure. NovaBone Dental Morsels is progressively resorbed and replaced by new bone tissue during the healing process.
The provided document is a 510(k) summary for the NovaBone Dental Morsels – Bioactive Synthetic Bone Graft, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria and a study to prove meeting those criteria in the way a clinical study for a diagnostic algorithm might.
Here's an analysis based on the information provided, highlighting what's present and what is not typically part of this type of submission:
1. A table of acceptance criteria and the reported device performance
This type of table, common for outlining quantitative performance metrics of a device against pre-defined thresholds, is not present for the NovaBone Dental Morsels in the provided document. The submission focuses on a comparative analysis with predicate devices to establish substantial equivalence.
Instead, the document provides a "Substantial Equivalence Comparison" (Table 3.1) of the new device (NovaBone Dental Morsels) to two predicate devices (PerioGlas and NovaBone Porous) across various characteristics:
| Characteristic | NovaBone Dental Morsels (New Device) | Predicate #1 (PerioGlas) | Predicate #2 (NovaBone Porous) |
|---|---|---|---|
| Intended Use | A non-structural osteoconductive bone void filler for osseous defects. | Same as new device | Same as new device |
| Indications | To fill and/or augment oral, dental intraosseous, and maxillofacial bone defects. Classif. Code: LYC | Same as new device. Classif. Code: LYC | Orthopedic bony voids in gaps of the skeletal system (i.e., the extremities and pelvis). Classif. Code: MQV |
| Application | Gently packed into defect sites as a non-structural scaffold for the body's natural healing and bone regeneration processes. | Same as new device | Same as new device |
| Material | Inorganic calcium phospho-silicate, thermally formed and bound together in a sodium silicate network. Individual particles fused to form porous graft material. | Same material as new device, but the individual particles are not fused together to create a porous material. | Same as new device |
| Device Porosity | Interconnected pore structure, with 40-60% pore volume and 50-400 micron pore size. | Dense individual particles. Space between packed particles provides approx 50% pore volume. | Same as new device |
| Particle Sizes | 500 - 1000 microns and 1000 - 2000 microns. | 90 - 710 microns (Smaller than new device). | 2000 - 5000 microns (Larger than new device). |
| Device Action | Ion diffusion and exchange at particle surfaces form a calcium phosphate surface layer, which acts as a scaffold for new bone formation throughout the graft site via osteoconduction. Continued ion diffusion and exchange results in material resorption. | Same as new device | Same as new device |
| Performance | Bone infiltration occurs throughout the graft site via osteoconduction, resulting in increased graft site mechanical stiffness and strength. | Same as new device | Same as new device. |
| Bone remodeling | New bone grows into the graft area via osteoconduction. The material is slowly absorbed and replaced by the host bone. | Same as new device | Same as new device. |
| Resorption Rate | Majority absorbed by six months. | Same as new device | Same as new device |
| Biocompatibility | Biocompatible, non-antigenic; full ISO 10993 testing. | Same as new device | Same as new device |
| Mechanical | Particulate material; not intended for use in load-bearing defects without proper internal or external fixation. | Same as new device | Same as new device |
| Package Format | PETG cups with Tyvek® lids. | PETG cup / Tyvek lid and PP syringe in foil pouch. | PETG cup / Tyvek lid and PP syringe in foil pouch. |
| Sterility | Gamma Irradiation, SAL 10-6. | EO Gas (cups/lids); and Gamma (syringe), both SAL 10-6. | EO Gas (cups/lids) and Gamma (syringe), both SAL 10-6. |
The acceptance criteria are implicitly that the NovaBone Dental Morsels are substantially equivalent to the predicate devices in terms of these characteristics. The reported device performance is described within each row of Table 3.1.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "in vivo bone void testing" and "Additional supporting in vitro data were supplied." However, it does not specify the sample size, country of origin, or whether the in vivo study was retrospective or prospective. The focus is on demonstrating similar behavior to existing devices rather than a detailed clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The "in vivo bone void testing" would likely involve histological analysis by pathologists, but details on the number and qualifications of experts involved in establishing ground truth are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This type of study is not applicable to this device. The NovaBone Dental Morsels is a bone graft material, not an AI-powered diagnostic device. Therefore, there are no "human readers" in the context of interpretation of images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical bone graft material, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "in vivo bone void testing" suggests that histological analysis (a form of pathology) would be used to assess new bone formation, material resorption, and tissue infiltration. The document states: "In vivo study data were presented supporting the osteoconductive nature of the device demonstrating new bone formation at early post-implantation periods, with no evidence of local or systemic adverse effects related to the device observed." This indicates a pathology-based ground truth for the in-vivo study.
8. The sample size for the training set
This information is not applicable as there is no "training set" in the context of this type of device submission. The device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
In summary:
The provided document is a 510(k) summary demonstrating substantial equivalence for a medical device (bone graft material). It outlines the device's characteristics and compares them to predicate devices. It briefly mentions "in vivo bone void testing" and "biocompatibility results" (ISO 10993) to support its safety and effectiveness, implying a pathology-based ground truth for the in-vivo studies. However, it does not contain the detailed performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods typically required for AI/ML or diagnostic device submissions. The "acceptance criteria" here are fundamentally met by demonstrating substantial equivalence to already marketed devices.
§ 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.