(80 days)
Ceracell® DENTAL is indicated for:
- Augmentation or reconstructive treatment of the alveolar ridge
- Filling of infrabony periodontal defects .
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filing of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of the maxillary sinus floor ●
- Filling of periodontal defects in conjunction with products . intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of perio-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
Ceracell® DENTAL is a synthetic absorbable radiopaque bio-ceramic for dental and maxillofacial bone regeneration, using pure phase beta-tricalcium phosphate with an open-cell sintered structure of biocompatible, bioactive organic and osteoconductive material.
Ceracell® DENTAL polygonal 'morsels' have a porosimately 80% and are available in a grain sizes from 150 - 2,000 µm, with the intended use of filling dental and maxillofacial bone defects. This level of porosity allows rapid ingrowth of the bone, and blood components are able to permeate the material, leading to osseous integration and vascularisation.
The material is doped with 4% sodium-magnesium-silicate to provide mechanical stability.
Ceracell® DENTAL morsels are available in a range of morsel sizes and quantities.
The final product is packed in glass vials, fitted with brombuty rubber stoppers, then subjected to a gamma radiation sterilization process before being packed in outer cartons.
Resorption time varies with technique from 4 to 12 months.
The provided FDA 510(k) clearance letters and summary are for a bone grafting material, Ceracell® DENTAL. These documents primarily focus on demonstrating substantial equivalence to a legally marketed predicate device (Cerasorb® Dental) rather than establishing new performance criteria through a detailed clinical study with acceptance criteria.
Therefore, the information required to populate all sections of your request (e.g., acceptance criteria, test set sample size, number of experts for ground truth, MRMC study results, training set details) is largely absent from these specific 510(k) documents. This is typical for a 510(k) submission for this type of device, where performance is often demonstrated through material characterization, biocompatibility testing, and comparison of technological characteristics to a predicate device, rather than extensive clinical efficacy trials with specific performance metrics defined by acceptance criteria in the way one might see for an AI/software device.
However, I can extract the available relevant information and explain what is not provided based on the nature of the submission.
Here is a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Substantial Equivalence: Device safety and effectiveness are substantially equivalent to the predicate device, Cerasorb® Dental (K051443). | The majority of device characteristics for Ceracell® DENTAL are identical to Cerasorb® Dental. Where not identical (device composition, volumetric porosity, phase purity), they are very similar, and these differences have no significant effect on device safety or effectiveness. |
| Biocompatibility: Device must be biocompatible. | Ceracell® DENTAL is described as having an "open-cell sintered structure of biocompatible, bioactive organic and osteoconductive material." (Implied to meet general biocompatibility standards). |
| Sterilization: Device must be terminally sterilized effectively. | "The final product is packed... then subjected to a gamma radiation sterilization process." (Implied to meet sterilization standards). |
| Porosity: Suitable for bone ingrowth. | "polygonal 'morsels' have a porosity of approximately 80%... This level of porosity allows rapid ingrowth of the bone, and blood components are able to permeate the material, leading to osseous integration and vascularisation." |
| Resorption Time: Appropriate for a bone grafting material. | "Resorption time varies with technique from 4 to 12 months." |
| Material Composition: Consistent with known safe and effective bone grafting materials. | "pure phase beta-tricalcium phosphate with an open-cell sintered structure... doped with 4% sodium-magnesium-silicate." (Compared to predicate, which also uses tricalcium phosphate). |
| Mechanical Stability: Sufficient for intended use. | "doped with 4% sodium-magnesium-silicate to provide mechanical stability." |
Critically, for this type of device, explicit quantitative "acceptance criteria" for clinical performance metrics (like sensitivity, specificity, accuracy, etc., which are common for AI/diagnostic devices) are not provided in these documents. The primary "acceptance criterion" for a 510(k) is often demonstrating substantial equivalence to a predicate, which usually involves comparing technological characteristics and showing that any differences do not raise new questions of safety or effectiveness.
2. Sample sized used for the test set and the data provenance
- Sample Size: The documents do not detail a specific "test set" in the context of a clinical performance study with human subjects, as would be common for AI/diagnostic devices. The evaluation focuses on material properties, biocompatibility, and comparison to a predicate device. If animal studies or limited human clinical data were part of the submission, their details are not included in this summary.
- Data Provenance: Not applicable in the context of a "test set" for clinical performance as described. The manufacturing location is listed as Frankfurt, Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no described "test set" requiring expert-established ground truth for performance evaluation in the way a diagnostic AI device would. The evaluation is based on material science, literature, and predicate device comparison.
4. Adjudication method for the test set
- Not applicable. There is no described "test set" for clinical performance requiring adjudication.
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 is a bone grafting material, not a diagnostic AI device. An MRMC study is not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (bone grafting material), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's clearance is primarily based on:
- Scientific and engineering principles: Demonstrating that the material properties (composition, porosity, mechanical stability, resorption) are suitable for the intended use.
- Biocompatibility testing: Ensuring the material is safe to be implanted in the human body (though specific test results are not in this summary).
- Literature review and established clinical use: Reliance on the known safety and effectiveness of similar tricalcium phosphate-based bone grafting materials, particularly the predicate device.
- Regulatory precedent: A successful 510(k) clearance often relies heavily on demonstrating scientific and technological similarity to a device already cleared by the FDA.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/machine learning model that would have a "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no "training set."
§ 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.