Tri-Ostetic is an osteoconductive putty that is intended 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 Tri-Ostetic paste set in 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 Tri-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.

Device Description

Tri-Ostetic is a sterile osteoconductive bone void filler. Tri-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. Tri-Ostetic forms a paste when mixed with sterile distilled water. Both powder and water are supplied pre-measured in separate containers. 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). Tri-Ostetic powder and the water are supplied sterile for single patient use only. Tri-Ostetic is biocompatible, bioresorbable and radio-opaque. Tri-Ostetic resorbs in the human body as bone ingrowth occurs when applied according to its indications for use.

AI/ML Overview

This document is a 510(k) summary for the Tri-Ostetic Bone Void Filler, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types for specific studies) are not present in the provided text as the nature of a 510(k) submission for a device like this primarily involves demonstrating equivalence through material data and a comparison to an already approved device.

Here's a breakdown of what can be extracted and what information is missing based on the prompt:

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

This information is not provided in the document. 510(k) summaries for simple devices like bone void fillers typically focus on demonstrating substantial equivalence to a predicate device through material composition, intended use, and general safety/biocompatibility, rather than setting and reporting against specific numerical performance acceptance criteria for a new clinical study. The document states: "The safety and effectiveness of Tri-Ostetic are adequately supported by the substantial equivalence information, materials data, and test results provided in the document submitted within the scope of this Pre-Market Notification." However, these specific test results and their acceptance criteria are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. As explained above, the submission relies on substantial equivalence and material data, not a clinical trial with a "test set" in the context of diagnostic or AI device evaluation.

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)

This information is not provided. There is no mention of a test set requiring expert ground truth establishment.

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

This information is not provided. There is no mention of an adjudication process for 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

This type of study is not applicable and not mentioned. The device is a bone void filler, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

This is not applicable and not mentioned. The device is a physical bone void filler, not an algorithm.

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

As there is no "test set" described for performance evaluation, the concept of "ground truth" as typically applied to diagnostic or AI devices is not relevant or discussed in this 510(k) summary. The "truth" here relates to the inherent properties of the material and its equivalence to a predicate device.

8. The sample size for the training set

This information is not provided. A "training set" is not relevant to this type of device submission.

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

This information is not provided. Not relevant.

Summary of the Study and "Proof" for Substantial Equivalence:

The provided document describes a 510(k) submission for the Tri-Ostetic Bone Void Filler. The "study" that proves the device meets (implicitly, rather than explicitly stated) acceptance criteria is the demonstration of substantial equivalence to a legally marketed predicate device, Cem-Ostetic™.

The evidence for this substantial equivalence is based on:

Identical Indications-for-Use: Tri-Ostetic is used to fill voids and gaps in bone, in extremities, spine, pelvis, or cranium, augmenting hardware for temporary support, and it is radio-opaque, biocompatible, and bioresorbable. These are stated to be identical to Cem-Ostetic™.
Identical Contraindications, Warnings, Precautions, and Potential Adverse Events: Again, this indicates a high degree of similarity in safety profile and application to the predicate.
Very Similar Technical Characteristics: While not detailed, the submission asserts that the technical characteristics are "very similar" to the predicate device. This would typically involve comparisons of material composition (calcium-based compounds), physical properties (forms a paste, sets in situ), biocompatibility, and bioresorbability.
Materials Data and Test Results: The summary indicates that "materials data, and test results" were provided in the full Pre-Market Notification document to support the safety and effectiveness. These tests would likely include biocompatibility testing (e.g., cytotoxicity, sensitization, irritation, systemic toxicity), mechanical properties (though it's not for structural support), and possibly resorption rates, all compared against acceptable benchmarks or the predicate. The specifics of these tests and their results are not included in this summary.

In essence, the "acceptance criteria" are implicitly defined by the properties and performance of the predicate device, Cem-Ostetic™, and the "study" is the collection of data and analysis demonstrating that Tri-Ostetic™ is sufficiently similar in all relevant aspects.

Summary

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AUG 1 9 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 use of the Tri-Ostetic Bone Void Filler.

Submitted By:	Berkeley Advanced Biomaterials Inc.
Date:	07-06-04
Contact Person:	François Génin, Ph.D.Phone: 510-883-0500; Fax: 510-883-0511
Proprietary Name:	Tri-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

B. DEVICE DESCRIPTION

C. SUBSTANTIAL EQUIVALENCE INFORMATION

Tri-Ostetic is substantially equivalent to the legally marketed, predicate device Cem-Ostetic™. 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 Tri-Ostetic are very similar to that of the predicate device. The safety and effectiveness of Tri-Ostetic are adequately supported by the substantial equivalence information, materials data, and test results provided in the document submitted within the scope of this Pre-Market Notification.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2004

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

Re: K041889

Trade/Device Name: Tri-Ostetic Regulation Number: 21 CFR 888.3034 Regulation Name: Bone Void Filler Regulatory Class: II Product Code: MQV Dated: August 1, 2004 Received: August 3, 2004

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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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 A Milken

Celia M. Witten, PhD, MD 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): K041889

Device Name: Tri-Ostetic

Indications For Use:

Tri-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 Tri-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. Tri-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.

Prescription Use
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AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)
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O Mark A Milhurn

Restorative, and Neurological Devices

K041889

510(k) Number_

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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.