Cem-Ostetic™ is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Cem-Ostetic™ paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic.™ is biocompatible and resorbs in the body as bone ingrowth occurs.

Device Description

Cem-Ostetic™ consists of a pre-measured formulation of distilled water and calcium-based compounds in a container that can be used to prepare a putty. Cem-Ostetic™ forms a paste when mixed with sterile distilled water. When 4 centimeter cubes (cc) of water are mixed with 10 cc of powder, the paste becomes hard after 5 minutes. Both powder and water are supplied pre-measured in separate containers. To prepare the putty, the water is first poured into the jar containing the powder and mixed with it for 60 seconds. For the next two minutes, the putty can be shaped into an implant or inserted into a syringe and injected into the surgical site (i.e., bony voids or gaps of skeletal system). The putty will harden on average within 5 minutes of contact between powder and water. The Cem-Ostetic™ powder and the water are supplied sterile for single patient use only.

AI/ML Overview

This document describes a 510(k) submission for the Cem-Ostetic™ Bone Void Filler. This is a medical device and not an AI/ML powered device. As such, the information requested, such as acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment, are not applicable in the context of this traditional medical device submission.

The provided text focuses on demonstrating substantial equivalence to predicate devices, which is the regulatory pathway for many non-AI medical devices. Key aspects of this submission are:

1. Acceptance Criteria and Reported Device Performance:

Not applicable in the context of an AI/ML device. For Cem-Ostetic™, the acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices (OsteoSet BVF Kit and Osteoplast) based on identical indications for use, contraindications, warnings, precautions, potential adverse events, and similar technical characteristics. The safety and effectiveness are supported by the provided substantial equivalence information, materials data, and test results.

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

Not applicable for a medical device of this nature. This device isn't evaluated on a "test set" of data in the same way an AI model would be. Its performance is assessed through material properties testing and comparison to predicate devices, not data analysis of a specific "test set."

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

Not applicable. The "ground truth" for this device typically involves material science testing (e.g., setting time, mechanical strength, biocompatibility), which is evaluated by engineers and scientists, not clinical experts establishing a diagnosis from a test set.

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

Not applicable.

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-assisted diagnostic tool for human readers.

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

Not applicable.

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

For this type of traditional medical device, ground truth is established through:

Material Science Testing: Evaluating properties like setting time, compressive strength, radio-opacity, and biocompatibility according to recognized standards.
Biocompatibility Studies: In-vitro and/or in-vivo testing to ensure the material does not elicit adverse biological responses.
Clinical Experience/Literature Review: Leveraging existing data and knowledge about the predicate devices and the behavior of similar materials in the body.

8. The sample size for the training set:

Not applicable. This device does not use machine learning, so there is no "training set."

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

Not applicable.

Summary

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BE RKELEY ADVANCED BIOMATERIALS, INC.

1933 Davis Street, Suite 307, . San Leandro, CA 94577, USA Tel: 510) 883 1644: Fax: (510) 883 1315 Ema l: info@hydroxyapatite.com http://www.livdroxyapatite.com

Image /page/0/Picture/3 description: The image shows the date 0 9 2003 and the number 1022622. There is a logo in the image that is difficult to make out. The text ISO9001 - ISO13485 is also present in the image.

510(K) Summary

In ¿ ccordance with the Food and Drug Admisnistration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CPR 807, this information serves as a Summary of Safety and Effectiveness for the use of the Cem-Ost tic TM Bone Void Filler.

Submitted By:	Berkeley Advanced Biomaterials, Inc.
Date:	5 January 2003
Contact Person:	François Génin, Ph.D.
Position:	President and CEO
Contact Information:	Phone: 510-883-1644;
	Fax: 510-883-1315
Proprietary Name:	Cem-Ostetic™
Common Name:	Bone Void Filler
Classification Name and Reference:	Unclassified
Device Product Code and Panel Code:	Orthopedics/87/MQV

DEVICE INFORMATION

A. INTENDED USES/INDICATIONS

Cera-Ostetic™ is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be locuted in the extremities, spine, pelvis, or cranium.

The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Cem-Ostetic™ paste set in situ or ex situ provides a voil filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ost tic ™ is biocompatible and resorbs in the body as bone ingrowth occurs.

B. DEVICE DESCRIPTION

Cen-Ostetic™ consists of a pre-measured formulation of distilled water and calciumbased compounds in a container that can be used to prepare a putty, Cent-Ostetic™ forms a p iste when mixed with sterile distilled water. When 4 centimeter cubes (cc) of water are mixed with 10 cc of powder, the paste becomes hard after 5 minutes. Both powder and water are supplied pre-measured in separate containers. To prepare the putty, the water is firs: poured into the jar containing the powder and mixed with it for 60 seconds. For the next two minutes, the putty can be shaped into an implant or inserted into a syringe and injo cted into the surgical site (i.e., bony voids or gaps of skeletal system). The putty will har len on average within 5 minutes of contact between powder and water. The Cem-Ostetic "M powder and the water are supplied sterile for single patient use only.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

Cenn-Ostetic™ is substantially equivalent to legally marketed, predicate devices OsteoSet BVF Kit and Osteoplast. The products have identical indications-for-use and identical cor traindications. They also have the same warnings, precautions and potential adverse events. The technical characteristics of Cem-OsteticTM are very similar to that of the predicate devices. The safety and effectiveness of Cem-Ostetic™ are adequately supported by the substantial equivalence information, materials data, and test results provided in the fill document submitted within the scope of this Premarket Notification.

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Image /page/1/Picture/1 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 wings and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 9 2003

François Génin, Ph.D. President and CEO Berkeley Advanced Biomaterials, Inc. 1933 Davis Street Suite 307 San Leandro, California 94577

Re: K022622

Trade/Device Name: Cem-Ostetic™ Regulatory Class: Unclassified Product Code: MQV Dated: November 22, 2002 Received: December 3, 2002

Dear Dr. Génin:

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.

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 - François Génin, Ph.D.

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) 594-4660. 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 premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

Mark N Matthews

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K022622

Device Name: Cem-Ostetic™ bone void filler

indications for Use:

Cem-Ostetic™ is an osteoconductive putty that is intended to be used to fill voids and raps that are not intringic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

The putty may be shaped and pressed into the void by hand or inserted into a syringe and njected into the surgical site. The Cem-Ostetic™ paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical orocedure. The set putty acts as a temporary support medium and is not intended to orovide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic.™ is biocompatible and resorbs in the body as bone ingrowth occurs.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Milliken

(Division Sign-Off) (Division Sign-Ord), Restorative Division of General DIVIsion of Neurological Devices

510(k) Number -

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.