Bi-Ostetic™ is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) 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 Bi-Ostetic™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.

Device Description

Bi-Ostetic™ is a sterile osteoconductive bone void filler. It consists of a formulation of calcium based compounds. This synthetic bone graft comes in the shape of granules or blocks. Bi-Ostetic™ is supplied sterile for single patient use only. Bi-Ostetic™ is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications for use. The implant is bioresorbable and radio-opaque.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the Bi-OsteticTM device meets those criteria. The document is a 510(k) summary statement and subsequent FDA clearance letter, which focuses on the device's substantial equivalence to previously marketed devices.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study results.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document states that the safety and effectiveness of Bi-Ostetic™ are "adequately supported by the substantial equivalence information, materials data, and test results provided in the full document submitted within the scope of this Premarket Notification." However, these "test results" are not detailed in the provided excerpt.

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.bydroxyapatite.com

Image /page/0/Picture/2 description: The image shows a black and white logo. The logo is composed of a triangle shape with a rounded shape on top. Inside the triangle are two shapes that look like the letters 'GG'.

1023702

ISO9001:94/EN4600

5 1 0 ( K ) Summary Statement for Bi-Ostetic]M

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 use of Bi-Ostetic TM Bone Void Filler.

Submitted By:	Berkeley Advanced Biomaterials, Inc.
Date:	30 October 2002
Contact Person:	François Génin, Ph.D.
Position:	President and CEO
Contact Information	Phone: 510-883-1644;
	Fax: 510-883-1315
Proprietary Name:	Bi-OsteticTM
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

Bi-OsteticTM is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) 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.

B. DEVICE DESCRIPTION

Bi-Ostetio™ is a sterife osteoconductive bone void filler. It consists of a formulation of calcium based compounds. This synthetic bone graft comes in the shape of granules or blocks. Bi-Ostetic™ is supplied sterile for single patient use only. Bi-Ostetic™ is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications for use. The implant is bioresorbable and radio-opaque.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

Bi-Ostetic™ is substantially equivalent to legally marketed, predicate devices Medtronic Mastergraft™ Resorbable Ceramic (K020986) and Interpore Cross International ProOsteon 500R (K990131). The products have identical indications-for-use, identical or very similar composition, and equivalent contraindications. They also have similar warnings, precautions and potential adverse events. The safety and effectiveness of Bi-Ostetic™ are adequately supported by the substantial equivalence information, materials data, and test results provided in the full document submitted within the scope of this Premarket Notification.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2003

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

Re: K023703

Trade/Device Name: Bi-OsteticTM Regulatory Class: Unclassified Product Code: MOV Dated: October 30, 2002 Received: November 4, 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. Isting 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) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millerson

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: K023703

Device Name: Bi-Ostetic™ bone void filler

Indications for Use:

The granules or blocks may be pressed into the void or into the surgical site by hand. The Bi-Ostetic™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic™ is brocompatible 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)

fr. Mark A. Milliken
(Division Sign-Off)

Restorative

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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.