(208 days)
CERASORB® Plus is recommended for:
- · Defects after extirpation of bone cysts
- · Augmentation of the atrophied jaw ridge
- · Sinus lift or sinus base elevation respectively
- · Filling alveolar defects after tooth extraction for jaw ridge support
- · Filling extraction defects to create an implant site
- · Filling of two or multi-walled infrabony pockets, and bifurcation and trifurcation defects
- · Defects after operative removal of retained teeth or corrective osteotomes
CERASORB® Plus is a sterile, synthetic, porous and biocompatible ceramic matrix roundish and polygonal crushed shaped morsels. This modification consists of purephase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and complies with the ASTM F 1088-04. The devices, when applied to a bony defect, create a network of large, smoothly interconnected pores providing different porosities (CERASORB® Plus mixture of granules with porosity of 35% and of 65%).
CERASORB® Plus is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. Due to their synthetic nature CERASORB® Plus does not pose any risk of potential allergic reactions and are neither locally nor systemically toxic.
In contact with vital bone the CERASORB® Plus granules, morsels or granulate is reabsorbed and gradually replaced by new bone.
CERASORB® Plus is provided in double sterile packages (sterilization via gamma irradiation) and are for single-use only.
The use of Beta-Tricalcium Phosphate in vivo is well known and has been studied and evaluated in numerous animal and human studies over the vears. These studies indicate overall excellent performance, biocompatibility, resorption and bone regeneration with CERASORB® derived thereof the performance of CERASORB® Plus in the areas of its intended use and have proven that the material is non-toxic, biocompatible, resorbable while in contact with vital bone over time is replaced by new bone at the defect size.
The provided document is a 510(k) summary for CERASORB® Plus, a bone void filler. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format typically expected for medical device performance evaluation.
Instead, the submission relies on the concept of substantial equivalence to predicate devices (CERASORB® DENTAL and CERASORB® M DENTAL) which have already established safety and effectiveness. The “study” proving the device meets criteria is primarily the comparison to these predicate devices and the existing knowledge on Beta-Tricalcium Phosphate (В-ТСР).
Here's an attempt to extract and synthesize the information based on your request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria (e.g., minimum tensile strength, specific resorption rate) are not explicitly stated within the provided text, they cannot be presented in a table. The primary "acceptance criteria" appear to be:
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Material Composition & Purity: Pure-phase Beta-Tricalcium Phosphate (В-ТСР) with high purity, compliant with ASTM F 1088-04. | CERASORB® Plus consists of "pure-phase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and complies with the ASTM F 1088-04." |
| Biocompatibility: Non-toxic, not allergenic. | "Due to their synthetic nature CERASORB® Plus does not pose any risk of potential allergic reactions and are neither locally nor systemically toxic." The use of Beta-Tricalcium Phosphate in vivo is "non-toxic, biocompatible." |
| Resorbability & Bone Regeneration (Osteoconductivity): Resorbed over time and replaced by new vital bone. | "In contact with vital bone the CERASORB® Plus granules... is reabsorbed and gradually replaced by new bone." "The material is... osteoconductive and resorbable." |
| Effectiveness for Intended Uses: Performs well for specific dental/maxillofacial defects. (Implicit: equivalent to predicate devices already proven effective). | "These studies indicate overall excellent performance, biocompatibility, resorption and bone regeneration with CERASORB® derived thereof the performance of CERASORB® Plus in the areas of its intended use." |
| Manufacturing Quality: Ensures batch-to-batch conformity and reproducibility. | "CERASORB® Plus is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility." |
| Sterility: Provided sterile. | "Provided in double sterile packages (sterilization via gamma irradiation)." |
Study Proving Acceptance Criteria:
The primary "study" or basis for proving these criteria is the claim of substantial equivalence to previously cleared/approved predicate devices (CERASORB® DENTAL PMA800035/ K051443 and CERASORB® M DENTAL K051443) and the established scientific understanding and historical use of Beta-Tricalcium Phosphate.
The document states: "The use of Beta-Tricalcium Phosphate in vivo is well known and has been studied and evaluated in numerous animal and human studies over the years. These studies indicate overall excellent performance, biocompatibility, resorption and bone regeneration with CERASORB® derived thereof the performance of CERASORB® Plus in the areas of its intended use and have proven that the material is non-toxic, biocompatible, resorbable while in contact with vital bone over time is replaced by new bone at the defect size."
2. Sample Size Used for the Test Set and Data Provenance
- The document does not describe a specific "test set" or clinical study with a defined sample size for CERASORB® Plus.
- Instead, it leverages existing literature and studies on Beta-Tricalcium Phosphate and the predicate devices. The "data provenance" mentioned is the general body of "numerous animal and human studies over the years" related to В-ТСР and the predicate devices, implying retrospective analysis of existing data. No specific country of origin is mentioned for these historical studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not provided as there isn't a new clinical study described for CERASORB® Plus with a ground truth established by a panel of experts.
- The "ground truth" for the safety and efficacy of Beta-Tricalcium Phosphate is implicitly established by the collective scientific and medical community's acceptance of the material through "numerous animal and human studies."
4. Adjudication Method for the Test Set
- An adjudication method is not applicable as there is no specific new test set or clinical study described in this 510(k) summary for CERASORB® Plus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is typically for evaluating diagnostic imaging systems or AI tools. CERASORB® Plus is a physical bone void filler.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not applicable. This device is a physical bone graft material, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" is based on scientific consensus and established clinical outcomes from "numerous animal and human studies" on Beta-Tricalcium Phosphate, as well as the regulatory clearance/approval of predicate devices. This falls under the category of outcomes data and expert consensus derived from years of research and clinical use of the material.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of an AI/algorithm for this physical medical device. The "training" for the understanding of the material's properties comes from the body of scientific literature and studies mentioned.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/algorithm, this question is not relevant to the provided submission. The scientific understanding of Beta-Tricalcium Phosphate's properties (its "ground truth") was established incrementally over time through experimental research, animal studies, and human clinical observations.
§ 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.