OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite. the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.

AI/ML Overview

The provided 510(k) summary for OsteoGraf/N-300 does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The document is a premarket notification for a medical device submitted to the FDA. It primarily focuses on:

Device identification: Submitter, device name, classification, and predicate device.
Device description: Composition, size, and nature of OsteoGraf/N-300.
Intended Use: Specific dental and oral surgery applications.
Comparison to predicate device: Stating that OsteoGraf/N-300 is 100% anorganic hydroxylapatite, its chemical composition, and conformance to ASTM standards.
FDA determination: A letter from the FDA stating that the device is substantially equivalent to a previously marketed device, allowing it to be marketed.

This type of submission, especially for a device from 1998, often relies on a demonstration of substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria. The equivalence argument is made based on material composition and intended use.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the provided text.

Here's a breakdown of what cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: Not present.
Sample size used for the test set and the data provenance: Not present; no test set or study data described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present; no ground truth or expert panel described for a study.
Adjudication method: Not present.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is a bone-grafting material, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: Not present.
The sample size for the training set: Not present; no training set described.
How the ground truth for the training set was established: Not present.

The 510(k) summary provided is not a clinical study report and thus does not contain the detailed performance data, patient cohort information, or expert evaluation methods that would be required to answer these questions.

Summary

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JUL 2 1998

510(k) SUMMARY

March 31, 1998

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

1. Submitter: CeraMed Dental, L.L.C. 12860 West Cedar Drive, Suite 110 Lakewood. CO 80228 (303) 985-0800
1. Device Name: OsteoGraf/N-300 Hydroxylapatite Classification Name: Endosseous implant for bone filling and/or augmentation
1. Predicate Device: Bio-Oss
1. Device Description: OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite. the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.

5. Intended Use:

The intended use of OsteoGraf/N-300 is for:

Treatment of infrabony periodontal defects. .
Augmentation of bony defects of the alveolar ridge. ●
Filling of extraction sites.
Sinus elevation grafting ●

Q. Comparison of Product Characteristics:

OsteoGraf/N-300 consists of 100% anorganic hydroxylapatite, Ca.o(PO2), OHz.

X-ray diffraction and infrared analysis (FTIR) show OsteoGraf/N-300 to be 100% hydroxylapatite. OsteoGraf/N-300 conforms to the requirements of ASTM standard #F1581, Composition of Anorganic Bone for Surgical Implants.

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in providing health and human services to the United States.

2 1998 .UL

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mark Bowerman Manager, Quality Assurance/Regulatory Affairs CeraMed Dental L.L.C. 12860 West Cedar Drive Lakewood, Colorado 80228

Re : K981182 Trade Name: OsteoGraf®/N-300 Requlatory Class: Unclassified Product Code: LYC Dated: March 31, 1998 April 1, 1998 Received:

Dear Mr. Bowerman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Bowerman

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general premarket notification" (21 CFR 807.97). information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timothy A Ulatows Directo Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K981182 510(k) Number (if known):

OsteoGraf/N-300 Device Name:

Indications For Use:

The intended use of OsteoGraf/N-300 1s for:

Treatment of infrabony periodontal defects. -
Augmentation of bony defects of the alveolar ridge .. -
Filling of extraction sites.
Sinus elevation grafting. ﺴﻪ

(PLEASE DO NOT VIRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Conc irrence of CDRH, Office of Device Evaluation (ODE)

Gerald Shipps
(Division Sign-Off)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 27 510(k) Number .

Prescription Use
(Per 21 CFR 801.109) √

Over-The-Counter Use_

(Optional Formal 1-2-96)

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.