(50 days)
Cerasorb® M DENTAL is recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of infrabony periodontal defects.
- Filling of defects after root resection, apicoectomy, and cystectomy.
- Filling 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).
Cerasorb® DENTAL is recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of infrabony periodontal defects.
- Filling of defects after root resection, apicoectomy, and cystectomy.
- Filling 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).
Cerasorb® Perio is recommended for:
- Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of infrabony periodontal defects
- Filling of single-or multi-wall bone pockets.
- Filling of bifurcations and trifurcations
Cerasorb® DENTAL, Cerasorb® M DENTAL and Cerasorb® Perio are a sterile, synthetic, ceramic matrix in either granular form (Cerasorb DENTAL), polygonal shaped morsels (Cerasorb M DENTAL) or polygonal broken granulate (Cerasorb Perio). This material consists of pure-phase Beta-Tricalcium Phosphate with a phase purity of > 97% and complies with the ASTM F 1088-04. The devices, when applied to a bony defect, create a matrix of large, smoothly interconnected pores providing an osteoconductive scaffold (Cerasorb DENTAL approx. 65 vol% [total porosity], Cerasorb M DENTAL approx. 65 vol% [total porosity] and Cerasorb Perio approx. 25 vol%). The different designs are managed and controlled by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. Due to their synthetic nature the devices are free of any biological contaminants and are neither locally nor systemically toxic. In contact with vital bone the Cerasorb granules, morsels or granulate is resorbed and gradually replaced by new bone. Cerasorb DENTAL, Cerasorb M DENTAL and Cerasorb Perio are provided in double sterile packaging (sterilized by gamma irradiation) and are for single-use only.
The provided document is a 510(k) premarket notification for Cerasorb® Dental, Cerasorb® M Dental, and Cerasorb® Perio, which are bone grafting materials. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies.
Therefore, many of the requested details regarding acceptance criteria, study design, sample size, ground truth, and expert involvement are not explicitly available in this document. The document mainly discusses the intended use, device description, and comparison to predicate devices to establish substantial equivalence.
Here's what can be inferred or stated based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to predicate devices. Specific quantitative performance metrics with defined acceptance thresholds for the new device are typically not required or presented in this type of submission. The performance is implied to be similar to the predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (General Safety & Effectiveness) | The FDA determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use (implied, as the letter permits marketing). |
| Biocompatibility | "All materials are biocompatible." |
| Resorbability and Replacement with New Bone | "In contact with vital bone the Cerasorb granules, morsels or granulate is resorbed and gradually replaced by new bone." (Similar performance claimed for predicate devices). |
| Material Conformity | "This access. ply with the ASTM F 1088-04." (Refers to the material's compliance with a standard). "The different designs are managed and reproduced by a validated manufacturing process which guarantees batch-to-batch conformity and reproducibility. Due to their synthetic nature, they are neither locally nor systemically toxic." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as this is a 510(k) submission primarily relying on previous predicate device data and material characterization, not a new clinical trial with a defined "test set" for performance evaluation in the typical sense.
- Data Provenance: The document implies reliance on existing data and regulatory clearances for the listed predicate devices (PMA800035, K992416, K040278, K033815, K970321). The devices are manufactured by curasan AG in Kleinostheim, Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts/Qualifications: Not applicable or provided. This type of submission does not involve a "test set" of cases evaluated by external experts to establish ground truth in the way AI/ML performance studies do. The ground truth for substantial equivalence is based on regulatory standards and the established performance of predicate devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or provided, as there is no mention of a "test set" requiring adjudication by multiple readers/experts.
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
- MRMC Study: No. This document concerns a bone grafting material, not an AI/ML-driven diagnostic device that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is not an AI/ML device.
7. The Type of Ground Truth Used
- Ground Truth: For a 510(k) of a bone grafting material, the "ground truth" for demonstrating substantial equivalence often relies on:
- Prior Regulatory Clearances/Approvals: The FDA's previous findings for predicate devices.
- Material Standards: Compliance with recognized standards like ASTM F 1088-04 for Beta-Tricalcium Phosphate.
- Pre-clinical data: (Though not detailed here, often part of the submission) such as in-vitro tests and animal studies demonstrating biocompatibility and osteoconductivity/resorbability.
- Clinical experience: The known performance and safety profile of the class of devices and the specific predicate devices.
The document states, "The effectiveness and safety of the Cerasorb designs compared to the predicate devices" are the basis for substantial equivalence, implying reliance on the established performance of the predicate technologies.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/ML device that uses a "training set."
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. This is not an AI/ML 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.