BioPlus 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 BioPlus 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. BioPlus is biocompatible and resorbs in the body as bone ingrowth occurs.

Device Description

BioPlus 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. BioPlus is supplied sterile for single patient use only. BioPlus 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 is a 510(k) summary for a medical device (BioPlus Bone Void Filler) and related FDA correspondence. It does not include information about specific acceptance criteria or a study that proves the device meets those criteria in the way described in the request (e.g., performance metrics like sensitivity, specificity, or human-AI comparison).

The submission relies on demonstrating substantial equivalence to a predicate device (Bi-Ostetic™ - K023703) rather than proving performance against specific quantitative acceptance criteria through a standalone study with performance metrics.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided input. The document focuses on regulatory equivalence rather than a clinical performance study with specific quantifiable results.

Here's a breakdown of why the requested information cannot be extracted:

Acceptance Criteria & Reported Performance: The document states that "The safety and effectiveness of BioPlus are adequately supported by the substantial equivalence information, materials data, and test results provided in the full document." However, it does not detail specific performance metrics (e.g., regarding bone ingrowth rate, void filling efficacy, or resorption time) or define quantitative acceptance criteria for those metrics. The "test results" mentioned are likely biocompatibility tests, material characterization, and potentially animal studies (though not detailed here), rather than a clinical trial with statistical performance endpoints.
Study Design Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): These are all elements of a clinical performance study. Since the submission relies on substantial equivalence and mentions "materials data, and test results" without detailing a clinical study with human or animal subjects that establishes specific performance against acceptance criteria, these details are absent.
Training Set Information: This is relevant for AI/ML devices. BioPlus is a physical bone void filler, not an AI/ML diagnostic or therapeutic device. Thus, there is no training set in the context of machine learning.

Summary

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K042636

DEC 1 4 2004

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 BioPlus Bone Void Filler.

Submitted By:	Berkeley Advanced Biomaterials Inc.
Date:	09-20-04
Contact Person:	François Génin, Ph.D.
Phone: 510-883-0500; Fax: 510-883-0511
Proprietary Name:	BioPlus
Common Name:	Bone Void Filler
Classification Name and Reference:	Class II
Device Product Code and Panel Code:	Orthopedics/87/MQV

DEVICE INFORMATION

A. INTENDED USES/INDICATIONS

B. DEVICE DESCRIPTION

C. SUBSTANTIAL EQUIVALENCE INFORMATION

BioPlus is substantially equivalent to legally marketed, predicate device Bi-Ostetic™ (K023703). 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 BioPlus 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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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2004

François Génin, Ph.D. Chief Executive Officer Berkeley Advanced Biomaterials, Inc. 1933 Davis Street Suite 307 San Leandro, California 94577

Re: K042636

Trade Name: BioPlus Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: November 19, 2004 Received: November 23, 2004

Dear Dr. Génin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prof to May 20, 1978, are examance with the provisions of the Federal Food, Drug, do noos that have been that do not require approval of a premarket approval application (PMA). and Cosmeter For (. 10) was the device, subject to the general controls provisions of the Act. The r ou may, diererere, mains 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 may or subject to Sacer as Sateral 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 r loase of actived that i Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I oderal 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 Orth 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) I mis letter will unow you to organ maing of substantial equivalence of your device to a legally premaired 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 If you desire specific advice 101 Jour as 101) 276-0120. Also, please note the regulation entitled, Contact the Office of County of County of Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination of Jour 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 vours,

Sincerely, yours,

Mark A. Millman

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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Indications for Use

510(k) Number (if known): K_04z 636

Device Name: BioPlus

Indications For Use:

BioPlus is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical Dior ras is an obtoberient are intended to be used to fill voids and gaps that are not intrinsic to or corner 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 The granules or blocks provide void filling material that acts as a temporary support medium. Diol tas Lianares or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. BioPlus is biocompatible and resorbs in the body as bone ingrowth occurs.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millican

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

Page 1 of 1

510(k) Number K042636

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.