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

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KO33110

DEC 1 0 2003

SECTION 14: SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

SUBMITTER INFORMATION 14.1

The Clinician's Preference LLC a. Company Name: 25188 Gennesse Trail Rd, Suite 150 b. Company Address: Golden, CO 80401 (303) 526-1041 Company Phone: ﻥ (303) 526-0695 Company Facsimile: Michael Czuchna d. Contact Person: Manager, RA and QA/QC
September 27, 2003 e. Date Summary Prepared:

DEVICE IDENTIFICATION 14.2

a.	Trade/Proprietary Name:	C-GRAFTTM
b.	Classification Name:	Bone filling and augmentationmaterial unclassified
c.	Product Code:	LYC

ﺮ ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ،

IDENTIFICATION OF PRECATE DEVICES 14.3 510(k) No. Date Cleared Device Company 03/28/1995 Interpore® 200 Granular K950165 Interpore Coralline Hydroxylapatite International OsteoGraf® / N-700 06/26/1998 K981214 CeraMed Dental K023799 02/05/2003 FRIOS® ALGIPORE® Friadent GMBH

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DEVICE DESCRIPTION 14.4

14.5 SUBSTANTIAL EQUIVALENCE

C-GRAFT™ is substantially equivalent to Friadent GMBH FRIOS® ALGIPORE® in terms of material composition, chemical analysis, functionality and intended use. C-GRAFT™ is also substantially cquivalent to Interporc International Interpore® 200 Granular Coralline Hydroxylapatite and CcraMed Dental OsteoGraf® / N-700 in terms of material, functionality, and intended use.

INTENDED USE 14.6

C-GRAFT™ is indicated for:

Treatment of intrabony defects; .
Augmentation of bony defects of alveolar ridge; .
Filling of extraction sites; and .
Sinus elevation grafting. .

TECHNOLOGICAL CHARACTERISTICS 14.7

C-GRAFT™ is equivalent to FRIOS® ALGIPORE® in terms of chemical composition. Tests were completed on the two materials to determine the chcmical and mineralogical compositions using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and X-ray Diffraction. Results of the tests show that the materials are equivalent in composition and meet the ASTM standard

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specifications for the composition of hydroxylapatite for surgical implants (ASTM F 1185-88).

14.8 CONCLUSIONS

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Review's Checklist is provided with this submission. Performance evaluations of C-GRAFT™ testing reports when compared to those of FRIOS® ALGIPORE® show that the two materials are equivalent both chemically and mineralogically. Comparisons of C-GRAFT™ to the predicate devices show the device to be substantially cquivalent.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of a stylized eagle with its wings spread, with three wavy lines below it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2003

The Clinician's Preference LLC Mr. Charles L. Morin Regulatory counsel Morin & Associates 388 Market Street, Suite 500 San Francisco, California 94111

Re: K033110

Trade/Device Name: C-GRAFTTM Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LYC Dated: September 27, 2003 Received: September 30, 2003

Dear Mr. Morin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Morin

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clus

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

510(k) Number:

Device Name:

C-GRAFT™

长033110

Indications for Use:

C-GRAFT™ is indicated for:

Augmentation of bony defects of the alveolar ridge 트
미 Sinus elevation grafting
Treatment of intrabony periodontal defects 도
트 Extraction socket grafting

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEED)

Concurrence of CDRH, office of Device Evaluation (ODE)

Prescription Use	/	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

Signature

(Division Sign-Off)

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

510(k) Number	K033110
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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.