Augmentation or reconstructive treatment of the alveolar ridge.
Filling of infrabony periodontal defects.
Filling of defects after root resection, apicoectomy, and cystectomy.
Filling of extraction sockets to enhance preservation of the alveolar ridge.
Elevation of the maxillary sinus floor.
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Device Description

OSferion D is a white porous material composed of Beta-tricalcium phosphate(ß-TCP). It is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. The ceramic material complied with US standard specification ASTM F 1088-04. The OSferion D product range consists of two product types with porosities of 75% and of three granule sizes (G0:0.15~~0.8mm,G1:0.5~~1.5mm,G2:1.0~3.0mm).

AI/ML Overview

This document is a 510(k) summary for the device OSferion D, a synthetic bone void filler. It describes the device, its indications for use, and compares it to predicate devices to establish substantial equivalence.

Based on the provided text, a conventional study demonstrating quantitative performance metrics against specific acceptance criteria for OSferion D is not present. The document focuses on establishing substantial equivalence to predicate devices, which is a regulatory pathway that does not typically involve a new clinical study with acceptance criteria and a detailed performance report in the same way a PMA or a de novo submission might.

Therefore, I cannot fulfill all parts of your request as the information is not provided in the input document.

Here's an assessment based on the available information:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices based on indications for use, materials, and design, rather than presenting a study against specific performance acceptance criteria for the new device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable/Not provided. The document does not describe a clinical performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not provided. No test set or ground truth establishment process is described.

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

Not applicable/Not provided. No test set or adjudication process is described.

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 device is a bone void filler, not an AI-powered diagnostic device. An MRMC study is not relevant here.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable/Not provided. No "ground truth" for a performance study is mentioned as no such study is described. The "ground truth" for substantial equivalence is the safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable/Not provided. No training set is mentioned as this is not an AI/ML device.

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

Not applicable/Not provided. No training set or ground truth establishment is mentioned.

Summary of Device and its Equivalence Claim:

The document for OSferion D states:

Acceptance Criteria (Implied by 510(k) pathway): Substantial equivalence to predicate devices in "indication for use, and in specifications of the material." The core acceptance criterion for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device and does not raise new questions of safety or effectiveness.
Study Proving Acceptance Criteria: The "study" is the 510(k) premarket notification process itself. The submission compared OSferion D to several predicate devices (Cerasorb® DENTAL, BioResorb® Macro Pore, OSferion, Vitoss® Scaffold Synthetic Cancellous Bone Void Filler) and found it to be substantially equivalent.
Reported Device Performance: The document doesn't provide quantitative performance data for OSferion D from a specific study. Instead, it asserts its performance is substantially equivalent to the predicate devices, which have established safety and effectiveness.
- Technological Characteristics Comparison: "OSferion D is substantially equivalent to the predicate devices in indication for use, and in specifications of the material."
- Conclusion: "When compared to the predicate device, this subject device "OSferion D" does not incorporate any significant changes in intended use, instruction for use, material, or design that could effect the safety or effectiveness of the device."

In essence, the document is a regulatory submission demonstrating equivalence, not a standalone performance study with detailed acceptance criteria and results.

Summary

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|Ko8156|

510(k) SUMMARY

JUL 2 8 2008

OSferion D

May 30, 2008

1 General Information

트 Owner/Operator: OLYMPUS TERUMO BIOMATERIALS CORP. 34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182, Japan Establishment Registration No: 3006617492
l Official Correspondent: Stacy Abbatiello Kluesner, RAC Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley PA18034-0610 Phone: (484) 896-5405 Facsimile: (484) 896-7128 Email: Stacy.Kluesner@olympus.com Establishment Registration No: 2429304
Manufacturer: OLYMPUS TERUMO BIOMATERIALS CORP. (Sterilization site) Hinode Factory 34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182. Japan Establishment Registration No: 3006617492

2 Device Identification

Device Trade Name:	OSferion D
Common Name:	Bone void filler, Synthetic
Regulation Number:	21 CFR 872.3930
Regulation Name:	Bone grafting material, synthetic
Regulatory Class:	II
Product Code:	LYC
Classification panel	Dental

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3 Predicate Device/Reference Device Information

	Predicate Device		Reference Device
DeviceName:	Cerasorb®DENTAL	BioResorb®Macro Pore	OSferion	Vitoss® ScaffoldSynthetic CancellousBone Void Filler
CommonName:	Bone Void Filler,Synthetic	Bone Void Filler,Synthetic	Bone void filler	Bone void filler
Manufacturer:	Curasan AG	Oraltronics DentalImplantTechnologyGmbH	OLYMPUSTERUMOBIOMATERIALSCORP.	ORTHOVITA, INC.
510(k) No.	K051443	K050260	K080065	K032409

র্ব Device Description

5 Indications for Use

It is intended to fill, augment, or reconstructive periodontal or bony defects of the oral and maxillofacial region.

Augmentation or reconstructive treatment of the alveolar ridge. .
Filling of infrabony periodontal defects. .
Filling of defects after root resection, apicoectomy, and cystectomy. .
. Filling of extraction sockets to enhance preservation of the alveolar ridge.
. Elevation of the maxillary sinus floor.

Filling of periodontal defects in conjunction with products intended for Guided Tissue • Regeneration (GTR) and Guided Bone Regeneration (GBR).

Filling of peri-implant defects in conjunction with products intended for Guided Bone . Regeneration(GBR).

Comparison of Technological Characteristics હ

OSferion D is substantially equivalent to the predicate devices in indication for use, and in specifications of the material.

Information provided in this submission supports the safety and effectiveness of OSferion D compared to the predicate device.

7 Conclusion

When compared to the predicate device, this subject device "OSferion D" does not incorporate any significant changes in intended use, instruction for use, material, or design that could effect the safety or effectiveness of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Terumo Biomaterials Corporation C/O Ms. Stacy Abbatiello Kluesner, RAC Regulatory Affairs & Quality Assurance Olympus America, Incorporated 3500 Corporate Parkway P.O. Box 610 Center Valley, Pennsylvania 18034-0610

JUL 2 8 2008

Re: K081561 Trade/Device Name: OSferion D Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: June 2, 2008 Received: June 13, 2008

Dear Ms. Kluesner:

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 - Ms. Kluesner

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

VK Hommeler fender my for CL

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

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081561

Indications for Use Statement

510(k) Number (if known) :

Device Name : OSferion D

Indications for Use :

It is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

. Augmentation or reconstructive treatment of the alveolar ridge.
. Filling of infrabony periodontal defects.
Filling of defects after root resection, apicoectomy, and cystectomy. ▶
Filling of extraction sockets to enhance preservation of the alveolar ridge. .
Elevation of the maxillary sinus floor.
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR),
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

ucon Ranne

Page 1 of _ 1

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

510(k) Number: C081561

: 00012

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.