Cem-Ostetic™ is an osteoconductive bone substitute formulated as cancellous, cortical or cortico-cancellous granules, blocks as well as injectable putty that are 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 granules or blocks may be pressed into the void or into the surgical site by hand. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. Cem-Ostetic™ provides a void filler that can augment hardware to support bone fragments during the surgical procedure and acts as a temporary support medium. This void filler is not yet 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-shaped ready-for-use formulation of cancellous, cortical or cortico-cancellous blocks or granules. The granules or blocks are supplied sterile for single patient use only.

AI/ML Overview

This document is a 510(k) summary for the Cem-Ostetic™ Bone Void Filler. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study related to specific acceptance criteria for performance. Therefore, most of the requested information regarding acceptance criteria and performance study details cannot be extracted from this document.

Here's an analysis based on the provided text:

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

The document does not provide a table of acceptance criteria or specific quantitative performance metrics for the Cem-Ostetic™ granules and blocks. Its primary claim is substantial equivalence to an existing device (Cem-Ostetic™ putty).

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. The document does not describe a clinical performance study with a test set of data.

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. The document does not describe a clinical performance study requiring expert ground truth establishment.

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

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

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 is a medical device for bone void filling, not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm.

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

Not applicable. The device's "safety and effectiveness" are supported by "substantial equivalence information, materials data, and test results" but no specific ground truth type for a performance study is mentioned. The focus is on material properties and comparison to a predicate device.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device.

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

Not applicable. There is no mention of a "training set."

Summary of what is provided in the document related to "acceptance criteria" and "study":

The document states that the safety and effectiveness of Cem-Ostetic™ granules and blocks are supported by:

Substantial equivalence information: Primarily demonstrating that the new granules and blocks are fundamentally similar to the already marketed Cem-Ostetic™ putty.
Materials data: This would typically involve laboratory testing of the physical and chemical properties of the material to ensure it meets specifications. Specific acceptance criteria for these material properties are not detailed in this summary, but would have been part of the full 510(k) submission.
Test results: Similar to materials data, these would be lab-based tests demonstrating biocompatibility, radio-opacity, and potentially mechanical properties relevant to its intended temporary support. Again, specific acceptance criteria and results are not provided in this summary.

The "study" referenced is the process of demonstrating substantial equivalence to a predicate device (Cem-Ostetic™ putty), rather than a clinical performance study with specific patient outcomes or diagnostic accuracy metrics. The key aspects of this "study" are:

Identical Indications-for-Use: Both the new device and the predicate are intended to fill voids and gaps not intrinsic to bone stability in extremities, spine, pelvis, or cranium.
Identical Contraindications, Warnings, Precautions, and Potential Adverse Events: This suggests a shared safety profile.
Very Similar Technical Characteristics: This implies that the material composition, physical form (even if different shapes like granules vs. putty), and other properties are comparable and do not raise new safety or effectiveness concerns.

Summary

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BERKELEY ADVANCED BIOMATERIALS, INC.

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

FEB 2 0 2003

Image /page/0/Picture/3 description: The image shows a black and white drawing of a UFO. The UFO has a dome-shaped top and a wide, flat bottom. The bottom of the UFO has a pointed edge. The drawing is simple and does not have a lot of detail.

KO30266

ISO9001:94/EN4600

510(K) Summary

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

Submitted By:	Berkeley Advanced Biomaterials, Inc.
Date:	15 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 (Granules and Blocks)
Classification Name and Reference	Unclassified
Device Product Code and Panel Code	Orthopedics/87/MQV

DEVICE INFORMATION

A. INTENDED USES/INDICATIONS

B. DEVICE DESCRIPTION

C. SUBSTANTIAL EQUIVALENCE INFORMATION

Cem-Ostetic TM granules and blocks are substantially equivalent to the legally marketed, predicate device Cem-Ostetic™ putty. The products have identical indications-for-use and identical contraindications. They also have the same warnings, precautions and potential adverse events. The technical characteristics of Cem-Ostetic™ are very similar to that of the predicate device. The safety and effectiveness of Cem-Osteric™ granules and blocks are adequately supported by the substantial equivalence information, materials data, and test results provided in the 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 Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a head and torso. The figure is facing to the right and appears to be in motion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2003

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

Re: K030266

Trade/Device Name: Cem-Ostetic"™ Regulatory Class: Unclassified Product Code: MQV Dated: January 21, 2003 Received: January 27, 2003

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,

sincerely yours,

Mark A. Milliken

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):

Device Name: Cem-Ostetic™ bone void filler

Indications for Use:

VO 30266

The granules or blocks may be pressed into the void or into the surgical site by hand. The putty may be shaped and pressed into the void by hand or inserted into a syringe and intected into the surgical site. Cem-Ostetic™ provides a void filler that can augment hardware to support bone fragments during the surgical procedure and acts as a temporary support medium. This void filler is not yet 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Mark N. Mulleus

Division Sign-Off) Division of General, Restorative and 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.