B-GENIN and R-GENIN are indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Device Description

B-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen and demineralized bone matrix (DBM) powder. The device is an implant where new bone can grow.

R-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen, demineralized bone matrix (DBM) and hydroxyapatite-tricalcium phosphate granules. The device is an implant where new bone can grow.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the typical sense of performance metrics (like sensitivity, specificity, accuracy, etc.) for a diagnostic device or a pass/fail threshold for a therapeutic device.

Instead, the document is a 510(k) Summary Statement for two medical devices, B-GENIN and R-GENIN, which are resorbable calcium salt bone void fillers. The "study" mentioned is not a clinical trial with acceptance criteria for device performance, but rather a set of tests to establish substantial equivalence to predicate devices and confirm certain material properties and safety aspects.

Here's a breakdown of the available information based on your requested categories, acknowledging that much of what you asked for is not explicitly present in this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence (B-GENIN)	Similar intended use, technological characteristics to Osteofill (K043420)	Utilize ground human cortical demineralized bone with animal carrier. Same intended use, sterile, single-patient, putty-like consistency and handling.
Substantial Equivalence (R-GENIN)	Similar intended use, technological characteristics to Allomatrix (K041168)	Utilize ground human cortical demineralized bone with synthetic calcium-based salts. Same intended use, sterile, single-patient.
Viral Inactivation	Demonstrated suitable viral inactivation potential.	Processing methods evaluated against a panel of viruses (HIV-1, HAV, HCV model, PPV, PRV) demonstrated suitable viral inactivation. Terminally sterilized by gamma radiation.
Osteoconductive Potential (DBM component)	Histopathological evidence of new bone formation.	Each batch of DBM tested using an athymic nudemouse model. Scored on a five-point linear scale (0-4) for bone formation at 28 days. (Note: "The osteoinduction assay results using this assay should not be interpreted to predict clinical performance in human subject.")
Biological Sterility	Sterile	Terminally sterilized by gamma sterilization.

2. Sample Size Used for the Test Set and Data Provenance

Viral Inactivation: The document mentions "a select panel of viruses." No specific sample size (number of viruses tested, repeats of tests) is provided, nor is the provenance of the viral strains. This is a lab-based, in vitro study.
Osteoconductive Potential: Uses an "athymic nudemouse model." No specific sample size (number of mice or DBM samples per batch) is provided. This is an in vivo animal model study. Data provenance is implied as being from the manufacturer's internal testing as part of "batch testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. The tests described are laboratory and animal studies, not human clinical studies requiring expert review of outcomes for "ground truth" establishment in the context of diagnostic or classification tasks. The histopathological evaluation in the nudemouse model would be performed by trained personnel (e.g., veterinary pathologists), but their number and qualifications are not specified.

4. Adjudication Method for the Test Set

Not applicable. The described "tests" are primarily laboratory and animal studies evaluating material properties and biological activity, not clinical studies with outcomes requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document describes a 510(k) submission, which focuses on substantial equivalence to existing predicate devices. It does not include a comparative effectiveness study, especially not one involving human readers and AI for an orthopedic bone void filler.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not a software/AI device. The "device" is a physical bone void filler.

7. Type of Ground Truth Used

Viral Inactivation: Laboratory assay results demonstrating viral reduction.
Osteoconductive Potential: Histopathological evidence of new bone formation in a nudemouse model. This is an animal model endpoint/biological readout. The document explicitly states this assay "should not be interpreted to predict clinical performance in human subject."
Substantial Equivalence: Comparison of material properties, intended use, and general characteristics to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The concept of a "training set" for an algorithm does not apply here.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for an algorithm. The "truth" for this device's safety and effectiveness relies on material characterization, viral inactivation studies, and animal model results, along with the established safety profiles of the predicate devices.

Summary

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X091912

BERKELEY ADVANCED BIOMATERIALS, INC.

901 Grayson Street, Suite 101, Berkeley, CA 94710, USA Tel: (510) 883 0500; Fax: (510) 883 0511 Email : info@hydroxyapatite.com http://www.hydroxyapatite.com

JUN 2 3 2010

510(K) Summary Statement

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 the device.

Submitted By:	Berkeley Advanced Biomaterials, Inc.
Date:	17 June 2009
Contact Person:	François Génin, Ph.D.
Position:	Chief Executive Officer
Contact Information:	Phone: 510-883-0500; Fax: 510-883-0511
Proprietary Name:	B-GENIN, R-GENIN
Regulation Name:	Resorbable Calcium Salt Bone Void Filler
Regulation Number:	888.3045
Classification:	Class II
Device Code/ Panel Code:	Orthopedics/87/MQV, MBP

DEVICE INFORMATION

A. INTENDED USE

B. DEVICE DESCRIPTION

B-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen and demineralized bone matrix (DBM) powder. The device is an implant where new bone can grow.

C. PREDICATE DEVICE

Osteofill (K043420) for B-GENIN and Allomatrix (K041168) for R-GENIN.

D. TECHNOLOGICAL CHARACTERISTICS

B-GENIN is substantially equivalent to Ostetofill (K043420). Both devices utilize ground human cortical demineralized bone combine with a carrier from animal origin. The devices have the same intended use, are provided sterile and for single patient only. Both devices are formulated so as to provide a putty-like product with similar consistency and handling characteristics.

R-GENIN is substantially equivalent to Allomatrix (K041168). Both devices utilize ground human cortical demineralized bone combined with synthetic calcium-based salts. The devices have the same intended use, are provided sterile and for single patient only.

E. PERFORMANCE DATA

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Product safety and effectiveness is supported by the substantial equivalence information, the materials data and the in vivo and in vitro test results provided in this Premarket Notification.

F. VIRAL INACTIVATION

The processing methods were evaluated for their viral inactivation potential. A select panel of viruses representing various virus types, shapes and genomes were evaluated. The panel included human immunodeficiency virus (HIV-1), hepatitis A virus, hepatitis C virus (bovine viral diarrhea as model), porcine parvovirus, and pseudorabies virus. The tests demonstrated suitable viral inactivation potential of the processing methods. The product is also terminally sterilized by gamma sterilization to also ensure its biological sterility.

G. OSTEOCONDUCTIVE POTENTIAL:

Each batch of DBM used in production is tested for osteoinductive potential using an athymic nudemouse model. The test involves an evaluation for histopathological evidence of new bone formation after intramuscular implantation of the test article. The process consistency is confirmed with this athymic nude-mouse model that utilizes a five-point linear scale (0,1,2,3,4) to score bone formation at 28 days*. The osteoinduction assay results using this assay should not be interpreted to predict clinical performance in human subject.

Edwards, J. T., Diegmann M. N., Scurborough, N. L.: Osteoinduction of human demineralized bone: characterization in a rat model, Clin. Orthopaedics, Vol. 357, pp. 219-28 (1998).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Berkeley Advanced Biomaterials, Inc. % François Génin, Ph.D. Chief Executive Officer 901 Grayson Street, Suite 101 Berkeley, California 94710

JUN 2 3 2010

Re: K091912

Trade/Device Name: B-GENIN and R-GENIN . Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV, MBP Dated: June 15, 2010 Received: June 16, 2010

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 includions 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 In microco in microadic 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 registmation, ince nece devices, good manufacturing practice, labeling, and prohibitions against misbrandi, ifsulf adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not maylers)

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 not 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); medical device reporting (reporting of medical

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Page 2 - François Génin, Ph.D.

device-related adverse events) (21 CFR 803); 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 100-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH0ffices/ucm11.5809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance Also, please note the regulation entitled, "Misbranding by reference to premarket notfication" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

yours,

Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K091912

Device Name: B-GENIN and R-GENIN

Indications for Use:

B-GENIN and R-GENIN are indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evalration (ODE)

(Division Sign-Off)
Division of Suryal, Orthopedic,
and Restorative Devices

Page 1 of 1

510(k) Number K04

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.