OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Device Description

OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stablity of the bony structure. OSferion is used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The OSferion range consists of two product types with porosities of 75% and 60%. Osferion (porosity:75%) tends to have less compression strength than Osferion (porosity:60%.) Products are supplied in blocks, cylinders, granules and wedges.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called OSferion, a bone void filler. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

However, the document does not contain information related to a study that establishes acceptance criteria for performance, device performance metrics, sample sizes for test or training sets, ground truth establishment, expert involvement, or any multi-reader multi-case (MRMC) comparative effectiveness studies.

The document concludes that "When compared to the predicate device, this particular device "OSferion" does not incorporate changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This implies that the acceptance criteria are met by demonstrating substantial equivalence to a legally marketed predicate device, rather than through a direct performance study with predefined metrics.

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

Here's what can be inferred or explicitly stated based on the text for the questions that can be answered:

A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. The document establishes substantial equivalence to predicate devices (chronOS and Vitoss) rather than reporting specific performance metrics against pre-defined acceptance criteria for OSferion itself. The "performance" is considered equivalent if the device shares the same intended use, materials (with some variation in porosity), and operates safely and effectively, as confirmed by regulatory review.
Sample sized 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 submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of specifications and clinical literature, not on a new clinical trial with a "test set" in the context of device performance metrics.
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. Ground truth establishment, in this context, is not mentioned as part of the 510(k) submission process described. The "ground truth" for regulatory clearance is the accepted safety and effectiveness of the predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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 void filler, not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This is not an algorithm-based device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided in the context of performance testing for this specific device. The "ground truth" for the 510(k) process is the established safety and effectiveness of the legally marketed predicate devices. The submission relied on "clinical literature provided in this submission supports the safety and efficacy of OSferion," which would presumably draw upon outcomes data or clinical observations related to similar materials.
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.
How the ground truth for the training set was established
- Not applicable / Not provided.

Summary of what the document implies about meeting acceptance criteria:

The acceptance criteria for OSferion, as presented in this 510(k) summary, are met by demonstrating substantial equivalence to existing predicate devices (chronOS and Vitoss). This means the device is deemed safe and effective if it shares the same:

Intended Use: Filling bony voids or gaps of the skeletal system that are not intrinsic to stability.
Patient Population: Individuals with bone voids or gaps caused by surgery or trauma.
Anatomical Location: Extremities, spine, and pelvis.
Labeling: Similar intended use, contraindications, warnings, precautions, and adverse events.
Basic Material Composition: β-Tricalcium phosphate.
Biocompatibility: Established.
Mechanical Strength Characteristics: Does not impart mechanical strength to the surgical site.
Sterility: Sterile, single use.

The document highlights that OSferion is "basically identical to the predicate devices in the indication for use, and is similar in specifications except for the porosity of the material." The "clinical literature provided in this submission supports the safety and efficacy of OSferion" as a basis for meeting these criteria.

Summary

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KO61499

JAN 26 2007

510(k) SUMMARY

OSferion

Regulatory Affairs & Quality Assurance

Email:Laura.storms-tyler@olympus.com Establishment Registration No: 2429304

34-3 Hirai, Hinode-machi, Nishitama-gun,

Establishment Registration No: Form 2891 to be submitted to FDA upon 510(k) clearance.

Olympus Biomaterial Corporation Hinode Factory

Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058, USA

Phone: 631-844-5688 FAX: 631-844-5554

Tokyo 190-0182. Japan

January 25, 2007

1 General Information

E Applicant: Olympus Biomaterial Corporation 34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182, Japan Establishment Registration No: Form 2891 to : be submitted to FDA upon 510(k) clearance. 배 Official Correspondent: Official Correspondent: Laura Storms-Tyler Executive Director
■ Manufacturer: (Sterilization site)

2 Device Identification

Device Trade Name:
Common Name:
Regulation Number:

Regulatory Class:

Classification Panel:

Regulation Name: Resorbable calcium salt bone void filler device
OSferion

Bone void filler

21 CFR 888.3045

ll
Product Code: MQV
Orthopedic

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3 Predicate Device Information

Device Name:	chronOS	Vitoss
Common Name:	Bone void filler	Bone void filler
Manufacturer:	Synthes	Orthovita
510(k) No.	K013072	K994337

4 Device Description

The OSferion range consists of two product types with porosities of 75% and 60%. Osferion (porosity:75%) tends to have less compression strength than Osferion (porosity:60%.) Products are supplied in blocks, cylinders, granules and wedges.

5 Indications for Use

Comparison of Technological Characteristics e

OSferion is basically identical to the predicate devices in the indication fir use, and is similar in specifications except for the porosity of the material.

Comparison between the subject and predicate devices is shown in Table1. The clinical literature provided in this submission supports the safety and efficacy of OSferion.

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Table 1. Comparison of Specifications Subject Device: OSferion Predicate Device: chronOS

Specifications	Sublect Devic		edicate Device
Indication/Intendeduse	Bone void filler, synthetic	Bone void filler, synthetic	Bone void filler, synthetic
Patient population	Individuals with bone voidsor gaps, caused by surgeryor trauma.	Individuals with bonevoids or gaps, caused bysurgery or trauma.	Individuals with bone voidsor gaps, caused by surgeryor trauma.
Anatomical location	Bony voids or gaps of theskeletal system, i.e., theextremities, spine andpelvis	Bony voids or gaps of theskeletal system, i.e., theextremities, spine andpelvis	Bony voids or gaps of theskeletal system, i.e., theextremities, spine and pelvis
Labeling	Same intended use,contradictions, warnings,precautions and adverseevents as predicate	See enclosure	See enclosure
Structure of thematerial	Interconnective porosity	Trabecular strucuturesimilar to cancellous bone	Interconnective porosity
Chemicalcomposition ofmaterial	B - Tricalciumphosphate(CaCO3)	ß - Tricalciumphosphate(CaCO3)	ß - Tricalciumphosphate(CaCO 3)
Porosity of material	60%,75%	90%	55%
Sterility	Sterile (High pressureSteam)Single use only	Sterile (gamma radiation)Single use only	Sterile (gamma radiation)Single use only
Biocompatibility	Established	Established	Established
Mechanical strength	Does not impartmechanical strength tosurgical site	Does not impartmechanical strength tosurgical site	Does not impart mechanicalstrength to surgical site

7 Conclusion

When compared to the predicate device, this particular device "OSferion" does not incorporate v men obtipant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 its wings spread, and three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus America, Inc. % Ms. Laura Storms-Tyler 3500 Corporate Parkway P.O. Box 610 Center Valley, Pennsylvania 18034-0610

JAN 2 6 2007

Re: K061499

Trade/Device Name: OSferion Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device. Regulatory Class: Class II Product Code: MQV Dated: December 13, 2006 Received: December 26, 2006

Dear Ms. Storms-Tyler:

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. Iisting 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.

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.

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Page 2 – Ms. Laura Storms-Tyler

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 (240) 276-0120 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours. Mark N. Melk

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): Device Name: OSferion Indications for Use:

Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

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)

icurrence of CDRH, Office of Device Evaluation (ODE) 10-101 Division of General, Restorative, and Neurological Devices

Experie : Minys Page

Page 1 of _ 1

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.