FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

C-GRAFT™ is a bone filling and augmentation matcrial indicated for use in dental applications. C-GRAFT™ is an inorganic, biocompatible calcium phosphate material derived from calcium-encrusted red sea algae. The algae are processed in order to develop an apatite material that is analogous to bone apatite. C-GRAFT™ is provided sterile in pre-filled vials and has a granule size range from 300-1000 microns.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a bone filling and augmentation material named C-GRAFT™. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance against specific acceptance criteria through clinical studies in the same way an AI/ML device would.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this 510(k) submission. The "study" here is a set of laboratory tests proving chemical and mineralogical equivalence.

Here's the information that can be extracted and a clear indication of what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence Determination)	Reported Device Performance (C-GRAFT™ vs. Predicate)
Material composition equivalent to predicate devices (FRIOS® ALGIPORE®, Interpore® 200 Granular Coralline Hydroxylapatite, OsteoGraf® / N-700).	C-GRAFT™ is equivalent to FRIOS® ALGIPORE® in terms of chemical composition based on ICP-MS and X-ray Diffraction. The materials meet ASTM F 1185-88 for hydroxylapatite in surgical implants.
Chemical analysis equivalent to predicate devices.	C-GRAFT™ is equivalent to FRIOS® ALGIPORE® in terms of chemical composition based on ICP-MS and X-ray Diffraction.
Mineralogical composition equivalent to predicate devices.	C-GRAFT™ is equivalent to FRIOS® ALGIPORE® in terms of mineralogical composition based on X-ray Diffraction.
Functionality equivalent to predicate devices.	Comparisons to predicate devices show substantial equivalence in functionality. (Specific test details not provided, but inferred from the overall claim of equivalence).
Intended use equivalent to predicate devices.	C-GRAFT™ has an intended use equivalent to the predicate devices (treatment of intrabony defects, augmentation of bony defects of alveolar ridge, filling of extraction sites, and sinus elevation grafting).

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. The "test set" here refers to the samples of C-GRAFT™ and its predicate (FRIOS® ALGIPORE®) used for chemical and mineralogical analysis. The specific number of samples tested for ICP-MS and X-ray Diffraction is not mentioned, but these are material property tests, not a clinical test set in the conventional sense.
Data Provenance: Not applicable. These were laboratory tests on the device materials, not data derived from patients or a specific country.

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 chemical and mineralogical composition is established via standardized analytical methods (ICP-MS, X-ray Diffraction) against established material standards (e.g., ASTM F 1185-88), not by expert consensus in the clinical sense.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of clinical data. This submission relies on objective laboratory test results.

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 a material-based device, not an AI/ML device, and no MRMC study was performed or required.

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

Not applicable. This is a material-based device, not an AI/ML device.

7. The type of ground truth used

The "ground truth" for the material's properties (chemical and mineralogical composition) was based on objective laboratory analytical methods (Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and X-ray Diffraction) compared against ASTM standard specifications for hydroxylapatite for surgical implants (ASTM F 1185-88). The predicate device (FRIOS® ALGIPORE®) also served as a comparative reference.

8. The sample size for the training set

Not applicable. This is a material-based device, not an AI/ML device, and therefore does not have a "training set" in that context.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

Summary

Regulation Number and Section

§ 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.