(300 days)
calc-i-oss is indicated for the filling and/or augmentation of intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
calc-i-oss is a synthetic resorbable osteoconductive bone graft substitute composed of tricalcium phosphate. The device is intended for dental intraosseous, oral, and cranio-/maxillofactial bony defects.
This document describes the calc-i-oss device, an osteoconductive bone void filler and synthetic resorbable bone graft material. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific acceptance criteria through a standalone study in the traditional sense of a clinical trial.
Therefore, the "acceptance criteria" here refers to the characteristics and performance expected of the device to be considered substantially equivalent to the predicate. The "study" proving it meets these "acceptance criteria" is primarily a comparison to the predicate device and internal testing data to confirm the device's properties.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) submission, the "acceptance criteria" are implicitly derived from the characteristics of the predicate device (Cerasorb Dental) and general safety/performance expectations for this class of device. The "reported device performance" is the description of the calc-i-oss device itself.
| Acceptance Criteria (from Predicate/General Device Type) | Reported calc-i-oss Device Performance |
|---|---|
| Indications for Use: | Indicated for defects after removal of cysts, Augmentation of alveolar crest (possibly with autologous bone and membrane), Apicoectomy and extraction defects (with membranes), Filling of defects after surgical removal of retained teeth, Sinus floor elevations, Defects after removal of autologous bone. |
| Chemical Composition: | > 99% Phase-pure synthetic β-tricalcium phosphate. |
| Form: | High purity β-tricalcium phosphate porous spherical granules. |
| Particle Size and Range (μm): | Granulate size range from 315 – 1600 μm. |
| Porosity / Resorption: | Interconnecting porous material 58% for high level of resorption. (Refer to enclosed Solubility Report for more information on porosity as well as resorption). |
| Biocompatibility: | β-TCP is known to be highly biocompatible, resorbable, and osteoconductive. (See attached confidential test reports and technical data, and literature references). |
| Sterility: | SAL 99% phase-pure synthetic β-tricalcium phosphate), physical properties (round macrostructure, specific granulate size range, 58% interconnecting porosity). |
- Predicate Device Characteristics: The established safety and performance profile of the legally marketed Cerasorb Dental (P800035).
- Scientific Literature/Clinical Experience: The general understanding and widespread use of β-tricalcium phosphate as a biocompatible, resorbable, and osteoconductive material in dentistry.
- Bench Testing Data: "confidential test reports and technical data" that confirm the device's specified properties (e.g., sterilization efficacy, solubility/resorption characteristics, material characterization).
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of an AI/machine learning model for this biomaterial device submission.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for an AI/machine learning model.
§ 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.