TRICOS T by BAXTER HEALTHCARE CORP.

TricOs T is indicated for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs T is a bone void filler without initial mechanical properties, therefore rigid fixation techniques may often be recommended.

TricOs T is intended to be packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, TricOs T is resorbed and replaced with bone during the healing process.

Fibrin matrix without the HA/TCP granules is not indicated for use as a bone void filler.

Device Description

TricOs T is a resorbable bone substitute that is replaced over time by newly formed bone. TricOs T consists of an inorganic calcium phosphate scaffold (HA/TCP granules) combined with a heterologous human fibrin matrix. The fibrin matrix acts as a 3D matrix and enhances the handling of the product by making it moldable and allows it to hold its shape.

AI/ML Overview

This appears to be a 510(k) summary for a medical device called TricOs T Bone Void Filler, submitted to the FDA in 2005. It describes the device's intended use, technological characteristics, and claims substantial equivalence to predicate devices, but does not contain the information requested in your prompt regarding acceptance criteria and a study proving those criteria.

Specifically, the document states:

"Nonclinical tests: TricOs T has been tested in in vivo and in vitro studies that document safety and effectiveness equivalent to that of the predicate devices."
"Substantial Equivalence Information: The intended use, composition, biocompatibility and select performance properties of TricOs T are substantially equivalent to commercially available predicate bone void filler products. The product is adequately supported by the substantial equivalence information, materials data, and testing results provided or referenced to in the Premarket Notification."

However, the provided text does not include:

A table of acceptance criteria and reported device performance.
Sample sizes used for test sets or data provenance.
Number and qualifications of experts for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study details or effect size.
Standalone (algorithm-only) performance results.
Type of ground truth used (expert consensus, pathology, etc.).
Sample size for the training set.
How ground truth for the training set was established.

This document is a regulatory submission summary that asserts the device's safety and effectiveness based on nonclinical tests and substantial equivalence but does not provide the detailed study results, acceptance criteria, or ground truth methodology you're asking for. Such details would typically be found in the full premarket notification (510(k)) document, not just the summary.

Summary

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K051722

510(k) Summary	NOV 1 8 2005
Submitted by:	Baxter Healthcare Corp.One Baxter WayWestlake Village, CA 91362805-372-3000
Contact Person:	Brian Bishop, Sr. Manager, Global Regulatory AffairsBiologics
Date Prepared:	24 June 2005
Proprietary Name:	TricOs T
Common Name:	Bone Void Filler
Classification Name:	Resorbable Calcium Salt Bone Void Filler (21 CFR§888.3045)
Predicate Device:	MBCPBIOMATLANTE510(k) K032268Collagraft Strip Bone Graft MatrixNeuColl, Inc.510(k) K000122Allomatrix PuttyWright Medical Technology, Inc.510(k) K020895TCP PuttyStryker Biotech510(k) K041421JAX-tcpSmith & Nephew, Inc.510(k) K033552

Description of the Device: TricOs T is a resorbable bone substitute that is
replaced over time by newly formed bone. TricOs T consists of an inorganic calcium phosphate scaffold (HA/TCP granules) combined with a heterologous

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human fibrin matrix. The fibrin matrix acts as a 3D matrix and enhances the

handling of the product by making it moldable and allows it to hold its shape.

Kost 722

. U/L

Intended Use of the Device: TricOs T is indicated for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs T is a bone void filler without initial mechanical properties, therefore rigid fixation techniques may often be recommended.

Fibrin matrix without the HA/TCP granules is not indicated for use as a bone void filler.

Technological Characteristics: TricOs T has similar characteristics to the predicate devices listed above. The product characteristics and design and chemical safety are in conformance with the ASTM standard for hydroxyapatite for implantation, F1185.

Nonclinical tests: TricOs T has been tested in in vivo and in vitro studies that document safety and effectiveness equivalent to that of the predicate devices.

Substantial Equivalence Information: The intended use, composition, biocompatibility and select performance properties of TricOs T are substantially equivalent to commercially available predicate bone void filler products. The product is adequately supported by the substantial equivalence information, materials data, and testing results provided or referenced to in the Premarket Notification.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle. The logo is black and white.

NOV 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Brian L. Bishop, RAC Associate Director Global Regulatory Affairs, Biologics Baxter Healthcare Corporation One Baxter Way Westlake Village, California 91362

Re: K051722

Trade/Device Name: TricOs T Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: November 1, 2005 Received: November 2, 2005

Dear Mr. Bishop:

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. Iisting 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 - Brian L. Bishop, RAC

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 (240) 276-0120 . 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Jay Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indication for Use

510(k) Number:

Device Name:

TricOs T is indicated for use as a bone void filler for voids or gaps Indications For Use: that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs T is a bone void filler without initial mechanical properties, therefore rigid fixation techniques may often be recommended.

TricOs T. Bone Void Filler

Fibrin matrix without the HA/TCP granules is not indicated for use as a bone void filler.

Prescription Usc X (Per 21 CFR §801.109)

Over-The-Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(a) Number K051722

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.