(610 days)
Osseolive® DENTAL is indicated for applications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled (artificial or degenerative) bone defects, e.g.:
- Defects after the extirpation of bone cysts .
- Augmentation of an atrophied alveolar ridge ●
- Sinus lift or sinus floor elevation (subantral augmentation) ●
- Filing of alveolar defects after tooth extraction for preservation of the alveolar ridge
- Filling of extraction defects to create an implant bed .
- Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects .
- . Defects after operative removal of retained teeth or corrective osteotomies
Osseolive® DENTAL is a synthetic absorbable radiopaque silicated calcium-alkali-phosphate ceramic for filling, bridging and reconstructing bone defects and for bone fusion in dental and maxillofacial applications. Osseolive® DENTAL has an open-cellular porosity of about 80% and is available as polygonal granyles of various grain sizes. It is resorbed by the body over a period of months and simultaneously substituted by local autologous bone. As a synthetic, bioactive ceramic material Osseolive® DENTAL has excellent intra- and extra-osseous tissue compatibility and is neither locally nor systemically toxic. Osseolive® DENTAL is a calcium-sodium phosphate with an open sintered structure. Osseolive® DENTAL morsels are highly porous, available in different grain size fractions between 150 and 2000 um. The high porosity allows blood components and body fluids to penetrate the material rapidly and unhindered. The chemical composition is a modification of tricalcium phosphate, where one calcium atom is replaced by one potassium atom and one sodium atom, resulting in increased solubility. Doping this glass ceramic with 4% sodium-magnesium-silicate on interstitial positions ensures the maximum mechanical stability. Osseolive® DENTAL has a resorption time of 3 to 12 months. Osseolive® DENTAL morsels are packaged for sale in glass vials.
The provided text includes a 510(k) summary for Osseolive® DENTAL, which is a dental bone grafting material. The document primarily focuses on establishing substantial equivalence to predicate devices through bench testing of material characteristics.
Here's an analysis of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics in the way a clinical study would for efficacy. Instead, it describes a "comparison summary" indicating that the majority of device characteristics are "similar to one or more of the predicate devices." Where differences exist, they "have no significant effect on device safety or effectiveness."
The "reported device performance" is presented as a list of material characteristics that were assessed, rather than specific numerical results against predefined criteria.
| Acceptance Criterion (Implicit) | Reported Device Performance (as stated) |
|---|---|
| Device characteristics similar to predicate devices. | "The majority of the device characteristics for Osseolive® DENTAL are similar to one or more of the predicate devices." |
| Differences from predicate devices have no significant effect on safety or effectiveness. | "Where they are not similar, the differences have no significant effect on device safety or effectiveness." |
| Inorganic elements analysis | Assessed |
| Bulk density and porosity (according to USP 34 ) | Assessed |
| X-ray characterization | Assessed |
| FTIR characterization | Assessed |
| Crystallinity characterization | Assessed |
| Phase analyses | Assessed |
| Specific surfaces (B.E.T. method, ASTM C 1251 & D 4780) | Assessed |
| Micro structure characterization (ISO 6474 & ASTM E 112) | Assessed |
| Ca/P ratio per mass test material | Assessed |
| Identification/qualification of degradation products (DIN EN ISO 10993-14) | Assessed |
| pH value (USP 34 ) | Assessed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes a "Bench test summary" performed by a "GLP compliant third party test laboratory." It assesses material characteristics. However, no specific sample sizes for the test set are mentioned. The provenance of the data is that it was conducted by a third-party lab, and the manufacturer is based in Germany. It's a bench test (laboratory testing), not a clinical study on patients, so concepts like retrospective/prospective or country of origin for patient data are not applicable here.
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 is not applicable to the data provided. The study is a series of bench tests on material characteristics, not an assessment requiring expert interpretation of clinical data or images to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to the data provided. As explained above, this was a bench test on material properties, not a clinical assessment requiring adjudication of observer findings.
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
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission is for a material (bone graft), not an AI-powered diagnostic device, so this type of study is not relevant to the provided text.
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 bone grafting material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench tests, the "ground truth" would be the established scientific and engineering standards and methods used to measure the material properties (e.g., USP 34 for bulk density, ASTM C 1251 for specific surfaces). These are physical measurements, not clinical diagnoses or expert consensus.
8. The sample size for the training set
This is not applicable. The submission describes a device that is a material product, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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.