This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP). This product presents an interconnected porous structure, similar to that of human cancellous bone. This product is available as irregular shaped particles of size 0.2~2.0 mm. It is supplied sterile by gamma irradiation.

AI/ML Overview

The provided document describes the OSTEON II device, a synthetic bone grafting material. It outlines the device's characteristics, indications for use, and performance data for biocompatibility and bench testing. However, it does not include specific acceptance criteria or a study designed to demonstrate that the device meets those criteria, especially in terms of diagnostic performance or clinical effectiveness.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (OSTEON) based on similar materials, indications for use, and design.

Here's an breakdown of the information that is available and what is missing based on your prompt:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Biocompatibility:
ISO Cytotoxicity	Met standards
ISO Pyrogenicity	Met standards
ISO Intracutaneous reactivity	Met standards
ISO Ames	Met standards
ISO Systemic toxicity	Met standards
ISO Sensitization	Met standards
ISO Implantation	Met standards
ISO Micro-nucleus	Met standards
Performance Bench Testing:
-Ca/P ratio	Met established specifications
-Crystalline Phase Compositions	Met established specifications
-Porosity	Met established specifications
-Water Solubility Test	Met established specifications
-Density	Met established specifications
-Crystallinity Value	Met established specifications

Missing: The document does not provide numerical acceptance criteria for any of these tests (e.g., "Cytotoxicity score must be < X"). It states that the tests were "completed" and "results show that the materials... are non-toxic and non-sensitizing" and "All test results demonstrate that the materials... met the established specifications." It doesn't define what those "established specifications" are, nor does it provide quantitative performance data for OSTEON II.

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

Not applicable/Not provided. This document does not describe a clinical study with a "test set" in the context of diagnostic device performance. The performance data presented are for laboratory-based biocompatibility and bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. This document does not pertain to an AI/diagnostic device that would require expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided.

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/Not provided. This device is a bone grafting material, not an AI-based diagnostic tool, so an MRMC study is not relevant.

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

Not applicable/Not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable/Not provided. For the biocompatibility and bench tests, the "ground truth" would be the established scientific methods and standards (e.g., ISO standards) that define what constitutes a passing result for cytotoxicity, pyrogenicity, material composition, etc.

8. The sample size for the training set:

Not applicable/Not provided. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable/Not provided.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The document details two types of studies used to support the substantial equivalence of OSTEON II:

Biocompatibility Testing:
- Purpose: To evaluate the biological safety of the proposed device's materials.
- Methodology: Followed the Blue Book memorandum G95-1 and ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing."
- Specific Tests Conducted: ISO Cytotoxicity, ISO Pyrogenicity, ISO Intracutaneous reactivity, ISO Ames, ISO Systemic toxicity, ISO Sensitization, ISO Implantation, ISO Micro-nucleus.
- Results: "The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use." (No quantitative results or specific acceptance criteria are provided, only a statement of conformance).
Performance Bench Testing:
- Purpose: To confirm the physical and chemical characteristics of the OSTEON II device.
- Specific Tests Conducted: -Ca/P ratio, -Crystalline Phase Compositions, -Porosity, -Water Solubility Test, -Density, -Crystallinity Value.
- Results: "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the OSTEON II met the established specifications necessary for consistent performance according to its intended use." (Again, no quantitative results or specific acceptance criteria are provided, only a statement of conformance to "established specifications").

Conclusion from the document: Based on these tests, the manufacturer concludes that OSTEON II is substantially equivalent to the predicate device OSTEON. The FDA's letter concurs with this determination for the stated indications for use.

Summary

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K112716

JAN 1 7 2012

CEMOZZ

510(k) Summary

12/26/2011

1. Company

	Submitter
Name	GENOSS Co., Ltd.
Address	1F Gyeonggi R&DB center, 906-5 Iui-dong, Suwon-si, Yeongtong-gu,Gyeonggi-do, 433-270, Korea
Phone/Fax	+82-31-888-5100/ +82-31-888-5105
Contact person	Sungwon Lee / QAswlee@genoss.com
Summary Date	September 14, 2011

2. Device Name

Proprietary name: OSTEON II Common name: . Bone grafting material Classification name: Bone grafting material, Synthetic

3. Predicated Device

K062834 OSTEON

4. Description

510(k) Summary

Page 1 of 3

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ભાગમાં આવેલા ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના

5. Indication for use

OSTEON II is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.

Periodontal/Infrabony defects
Ridge augmentation
Extraction sites (implant preparation/placement)
Sinus lifts
Cystic cavities

6. Technological Characteristics

OSTEON II has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of OSTEON II, OSTEON are as following

	Material	Device name
1	Hydroxyapatite(HA)	OSTEON	OSTEON II
2	Beta-tricalciumphosphate(β-TCP)	55~75wt%	25~45wt%
	Particles of size	25~45wt%	55~75wt%
		0.3~2.0 mm	0.2~2.0mm
	Indication for use	OSTEON (II) is intended for use as a bone graftingmaterial to fill, augment or reconstruct periodontal ororal/maxillofacial defects.- Periodontal/Infrabony defects- Ridge augmentation- Extraction sites (implant preparation/placement)- Sinus lifts- Cystic cavities	OSTEON (II) is intended for use as a bone graftingmaterial to fill, augment or reconstruct periodontal ororal/maxillofacial defects.- Periodontal/Infrabony defects- Ridge augmentation- Extraction sites (implant preparation/placement)- Sinus lifts- Cystic cavities
	Sterilization	Gamma Irradiation	Gamma Irradiation

510(k) Summary

Page 2 of 3

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GENOSS

7. Performance Data

Biocompatibility testing on the proposed OSTEON II has been completed. Requirements for biological evaluation of the proposed device were based on the Blue Book memorandum G95-1 issued on May 1, 1995, Use of International Standard ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing ." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed:

-ISO Cytotoxicity -ISO Pyrogencity -ISO Intracutaneous reactivity -ISO Ames

-ISO Systemic toxicity -ISO Sensitization · . -ISO Implantation -ISO Micro-nucleus

The proposed OSTEON II was evaluated using the following performance bench testing to confirm the performance characteristics:

-Ca/P ratio	-Crystalline Phase Compositions
-Porosity	-Water Solubility Test
-Density	-Crystallinity Value

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the OSTEON II met the established specifications necessary for consistent performance according to its intended use.

7. Conclusion

Based on the information provided in this premarket notification of GENOSS Co., Ltd. Concludes that OSTEON II is substantially equivalent to predicate devices

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Sungwon Lee Quality Assurance Assistant Manager Genoss Company, Limited 1F Gyeonggi R&DB Center 906-5 Iui-Dong Suwon-Si, Yeongtong-Gu, Gyeonggi-Do Republic of Korea 443-270

JAN 1 7 2012

Re: K112716

Trade/Device Name: OSTEON II Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: January 4, 2012 Received: January 5, 2012

Dear Mr. Lee:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Lee

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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CEMOZZ

Indication for use

	510(k) Number:
--	----------------

Device Name: OSTEON II

Indication for use:

OSTEON II is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects

Periodontal/Infrabony defects
Ridge augmentation
Extraction sites (implant preparation/placement)
Sinus lifts
Cystic cavities

イ Prescription Use __ (Part 21 CFR 801 Subpart D)

Indication for use

AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number: K112716

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.