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510(k) Data Aggregation
(332 days)
Straumann cerabone
Straumann® cerabone® is used in the following intra-oral surgical procedures:
- · Alveolar ridge augmentation/ reconstruction
- · Filling of defects after root resection and apicoectomy
- · Filling alveoli after tooth extraction
- Sinus elevation
Straumann® cerabone® is a xenogeneic hydroxyapatite ceramic for implantation into a vital bone bed during intra-oral surgical procedures. It is manufactured from bovine cancellous bone in a high temperature sintering process lasting several hours at temperatures of up to 1250°C. This high temperature process results in all organic components being eliminated so that the risk of occurrence of allergic side effects or the occurrence of rejection reactions is reduced. Straumann® cerabone® is made of over 95% of Pentacalcium-hydroxy-[tri]-phosphate Ca5(PO4)3(OH)
This is a 510(k) summary for a medical device called Straumann® cerabone®, a bone grafting material. There is no mention of an AI device in the provided text, therefore, the request cannot be fully fulfilled.
However, I can extract information related to the device's acceptance criteria and the studies that prove it meets those criteria, as if it were a non-AI device.
Device Name: Straumann® cerabone®
Device Type: Xenogeneic hydroxyapatite ceramic bone grafting material
Here's the closest representation of the requested information based on the provided text, adapted for a non-AI medical device:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Primary Claim: Substantial Equivalence to Predicate Device | Comparison of design, technological characteristics, and indications for use. | The subject device (Straumann® cerabone®) and the predicate device (Geistlich Bio-Oss® K122894) are both sterile, biocompatible porous bone mineral materials for use in the same intra-oral surgical procedures. Both are based on pure cancellous bovine bone mineral (free from organic compounds), have a rough surface structure, interconnecting macro- and micro-pores, and act as a scaffold. The comparison table (pages 5 & 6) indicates a high degree of similarity in material, origin, form, structure/density, sterilization method, and shelf life. The indications for use for the subject device are a subset of the predicate's indications. |
| Sterilization & Shelf Life | Validation of sterilization process (per ISO 11137-1) and shelf life (per ASTM F1980). | Validation performed per ISO 11137-1 for sterilization and per ASTM F1980 for shelf life. |
| Biocompatibility | Biocompatibility testing per ISO 10993-1, including: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), Subchronic Toxicity (ISO 10993-11), Genotoxicity (ISO 10993-3), Implantation (ISO 10993-6). | Biocompatibility testing performed per ISO 10993-1 and the specified sub-parts. (Results implicitly met as determined substantially equivalent). |
| Physicochemical/Material Characterization | Physicochemical and material characterization per ASTM F 1185-03 and ASTM F 1581-99. | Characterization performed per ASTM F 1185-03 and ASTM F 1581-99. (Results implicitly met as determined substantially equivalent). |
| Viral Inactivation | Demonstration of viral inactivation through validation of manufacturing steps, assessment of potential pathogenic burden, and quality management system. Compliance with ISO 22442-3. | Viral inactivation demonstrated through validation of manufacturing steps and assessment of potential pathogenic burden. A quality management system is in place. Zoonosis assessment demonstrated validated manufacturing processes are sufficient to ensure reduction of viral burden in accordance with FDA-recognized standard ISO 22442-3. |
| Osteoconductive Capacity | Assessment of osteoconductive capacity in intra-oral defects, with comparison to predicate device. | The osteoconductive capacity of Straumann® cerabone® in intra-oral defects was assessed in a kinetic study in minipigs with comparison to the primary predicate Bio-Oss®. The performance of cerabone was equivalent to the primary predicate device Bio-Oss. |
| Clinical Efficacy/Safety | Review of clinical literature to support proposed Indications for Use. | A review of the clinical literature was performed. The reviewed literature supports the use of Straumann® cerabone® in the proposed Indications for Use. |
Regarding the other requested points, which are typically relevant for AI/Diagnostic devices:
- 2. Sample sized used for the test set and the data provenance: Not applicable for this type of medical device's performance testing. The "test set" here refers to the subjects in the animal study and potentially the scope of the literature review.
- Animal study: Minipigs were used. The exact number is not specified, but it's referred to as a "kinetic study."
- Clinical Literature Review: No specific sample size as it's a review of existing literature.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a bone graft material is typically established through histological analysis in animal models or clinical outcomes in human studies/literature, not expert consensus on images or interpretations.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Animal Study: Histological and potentially macroscopic evaluation of bone formation and integration in minipigs. Comparative performance against the predicate device.
- Clinical Literature Review: Published clinical outcomes data and evidence from human studies.
- 8. The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI device.
In summary, the provided document details the non-clinical performance data (sterilization, biocompatibility, material characterization, viral inactivation, and an animal study) and a clinical literature review to demonstrate that Straumann® cerabone® is substantially equivalent to its predicate device, Geistlich Bio-Oss®, for its indicated uses. The information provided is typical for a medical device submission but lacks the specifics about AI-related criteria.
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