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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.

2. Sample Size for the Test Set and Data Provenance

The provided text does not describe a specific clinical "test set" in the context of a prospective clinical study with human subjects. Instead, the evidence for substantial equivalence relies on:

• Material Characterization: "confidential test reports and technical data" (likely laboratory-based, mechanical, chemical, and biological testing as per ISO standards for biomaterials).
• Literature Review: "Numerous articles on safety and effectiveness are available concerning indications for use in dentistry and are noted in the literature" for β-TCP.
• Comparison to Predicate: Direct comparison of the new device's characteristics (composition, form, particle size, porosity, indications) to the legally marketed Cerasorb Dental.

Therefore, phrases like 'sample size for the test set' or 'data provenance (e.g. country of origin)' are not directly applicable to a traditional clinical study as detailed in this 510(k) summary. The "data" referenced is primarily pre-clinical/bench testing and comparison to an established predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This question is also not applicable to the presented 510(k) submission. There is no mention of a "test set" requiring expert consensus for ground truth, nor is there any description of expert qualifications for such a process. The "ground truth" for a 510(k) primarily relates to the established safety and effectiveness of the predicate device and the scientific validity of the pre-clinical tests performed on the new device.

4. Adjudication Method for the Test Set

Since no clinical "test set" involving human data and expert review is described, an adjudication method (such as 2+1 or 3+1) is not applicable to this submission.

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

This question is not applicable. The calc-i-oss device is a bone graft substitute material, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or described.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. The calc-i-oss device is a biomaterial, not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established through:

• Material Specifications: Chemical composition (>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.

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