(104 days)
Osbone® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g .:
- · Defects after removal of bone cysts
- · Augmentation of the atrophied alveolar ridge
- · Sinus lift and sinus floor elevation (subantral augmentation)
- · Filling of alveolar defects following tooth extraction for alveolar ridge preservation
- · Filling of extraction defects to create an implant bed
- · Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects
- · Support function for a membrane in controlled tissue regeneration (CTR)
- · Defects after surgical removal of retained teeth or corrective osteotomies
- · Other multi-walled bone defects of the alveolar processes.
Osbone® DENTAL is an open-cellular, synthetic bioceramic for bone regeneration. It is comprised of a pure phase hydroxyapatite with an open sintering structure resulting in a biocompatible, bioactive and osteoconductive biomaterial. Osbone® DENTAL morsels are open-cellular highly porous morsels, ranging from 150-8000 um for filling bone defects in dental procedures. While Osbone® DENTAL can be manufactured with a granule size of up to 8000 um, curasan will only market granule sizes of 0.25-2.0 mm, which is within the size range of the predicate devices. The high porosity helps to accelerate ingrowth of bone.
Here's an analysis of the provided text regarding the acceptance criteria and study for Osbone® DENTAL:
1. Table of Acceptance Criteria and Reported Device Performance
The submission for Osbone® DENTAL is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices rather than proving a device meets specific, pre-defined quantitative acceptance criteria in a clinical study. Therefore, the "acceptance criteria" here are based on demonstrating that Osbone® DENTAL is as safe and effective as its predicates.
| Feature | Osbone® DENTAL Performance (as claimed) | Comparison to Predicate Devices (Implied Acceptance) |
|---|---|---|
| Intended Use | Multi-walled bone defects, alveolar ridge augmentation, sinus lift, extraction socket filling, infrabony pockets, CTR support, defects after retained teeth removal/osteotomies. | "Identical to the predicate devices" (Summary Section 6), and the comparison table shows highly overlapping indications for use across all predicates. Acceptance implies the indications are substantially equivalent. |
| Principles of Operation | Morsel size selection, mixing with autologous bone, application to graft bed, porous structure for bone ingrowth. | "Identical to the predicate devices" (Summary Section 6). Acceptance implies the fundamental mechanism of action is consistent with existing devices. |
| Technological Characteristics (Form) | Granules | Similar to Bio-Oss, Endobon (granular form available), and OsteoGraf/D. Acceptance implies the form factor is not a significant difference. |
| Technological Characteristics (Material) | Pure phase hydroxyapatite, synthetic, open-cellular bioceramic | Similar to OsteoGraf/D (synthetic HA) and Bio-Oss/Endobon (bovine bone-derived HA). The submission argues the differences (synthetic vs. bovine) do not impact safety/efficacy. Acceptance hinges on this argument being sufficient. |
| Technological Characteristics (Granule Size) | 0.25-2.0 mm (marketed range); open-cellular, highly porous. Specific marketed sizes: 0.25-1.0 mm, 1.0-2.0mm. | Sizes fall within the range of predicate devices (Bio-Oss: 0.25-2.0 mm; Endobon: 0.5-2.0 mm; OsteoGraf/D: 0.25-0.42 mm). "Differences... are limited to minor differences in granule size... that do not impact safety and efficacy." Acceptance requires that these minor differences are deemed non-critical. |
| Technological Characteristics (Porosity) | $80 \pm 5%$ (material); $75 \pm 5%$ (granular form). Open cellular, highly porous. | Comparable to Bio-Oss (75-80%) and Endobon (45-85%). "The size and porosity of the Osbone® DENTAL granules (morsels) that curasan intends to market are within the range of the size and porosity of the predicate devices." Acceptance based on being within predicate range. |
| Resorption | Partially resorbable. Extremely slow resorption kinetics due to high-temperature sintered HA. | Compared to Bio-Oss (Partially resorbable) and OsteoGraf/D ("Essentially non-resorbable"). The submission argues the "resorption characteristics of the proposed and predicate devices are essentially identical" despite terminology differences. Acceptance implies this justification is satisfactory. |
| Biocompatibility | Established (non-clinical testing, in compliance with ASTM F1185-03, ISO 13779-1, FDA guidance). | Expected to be equivalent to established predicates. Acceptance is based on meeting recognized standards for synthetic HA and the general understanding that HA is biocompatible. |
| Sterility | Sterile, non-pyrogenic, single patient use. | Similar to all predicate devices. Acceptance requires demonstration of standard sterilization and freedom from pyrogens. |
| Mechanical Characteristics | Does not impart mechanical strength to surgical site. | Similar to Bio-Oss. Consistent with the typical understanding of bone void fillers not being load-bearing. Acceptance assumes this functional characteristic is understood and similar to relevant predicates. |
| Safety and Effectiveness | Supported by materials characterization data, biocompatibility information, and history of safe clinical use for HA products. | The overall "acceptance criterion" for a 510(k) is substantial equivalence in terms of safety and effectiveness. The report concludes that Osbone® DENTAL is substantially equivalent to the predicates. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission is for a 510(k) premarket notification and relies on demonstrating substantial equivalence to existing devices, primarily through non-clinical testing and comparison of technological characteristics. No clinical testing was submitted in support of this 510(K) premarket notification (Section 9).
- Data Provenance: Not applicable for a clinical test set. Non-clinical data (materials characterization, biocompatibility) are derived from in-vitro testing and product specification analyses of Osbone® DENTAL, conducted by curasan AG (Germany).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable, as no clinical test set requiring expert-established ground truth was used for this submission. The "ground truth" for substantial equivalence is derived from the established safety and effectiveness of the legally marketed predicate devices.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical test set or human reader evaluation was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- Not applicable. This device is a synthetic bone void filler and not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not applicable. This device is a physical medical implant, not an algorithm or software.
7. The Type of Ground Truth Used
- The "ground truth" for this 510(k) submission is the established safety and effectiveness of the identified predicate devices (BIO-OSS, Endobon, OsteoGraf/D). The submission makes its case by demonstrating that Osbone® DENTAL shares the same indications for use, principles of operation, and technological characteristics, and that any minor differences do not impact safety or efficacy. The "truth" is therefore based on regulatory precedent and a detailed comparison against accepted standards and devices.
8. The Sample Size for the Training Set
- Not applicable, as no algorithm or machine learning model was developed or trained for this device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no algorithm or machine learning model was developed or trained for this device.
§ 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.