TricOs A Resorbable Bone Substitute is indicated for use as a bone void filler for voids and 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 A Resorbable Bone Substitute is intended to fill, augment, or reconstruct bony defects of the oral and maxillofacial region. Following placement in bony voids or gaps, TricOs A Resorbable Bone Substitute is resorbed while providing support for the in-growth of bone during the healing process. TricOs A Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.

Device Description

TricOs A Resorbable Bone Substitute consists of an inorganic calcium phosphate scaffold that is mixed with a heterologous human fibrin matrix prior to application. The fibrin matrix acts as a binder for the calcium phosphate scaffold, imparting favorable handling characteristics to the product to facilitate the surgical procedure, and acting as a three-dimensional matrix that supports the in-growth of bone.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "TricOs A Resorbable Bone Substitute." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving the device meets them in the way a new, high-risk device might.

Here's an analysis based on the provided text, addressing your questions where possible:

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria (e.g., specific percentages for success, adverse event rates, or precise mechanical properties) for the TricOs A Resorbable Bone Substitute as a distinct set of performance targets. Instead, the core of the submission is to demonstrate that TricOs A is substantially equivalent to its predicate device, TricOs T, with regard to technological characteristics, performance, and intended use.

The "performance" described is in comparison to the predicate, and is generally qualitative, focusing on its function as a bone void filler and its ability to support bone in-growth and resorption.

Acceptance Criteria (Implied)	Reported Device Performance
Material & Component Specifications: Similar to predicate device.	"The TricOs T and TricOs A device material and component specifications are similar." "The device components continue to meet the same material testing standards and sterilization processing standards."
Performance as a Bone Void Filler (Skeletal System): Verified through animal studies and functional/biocompatibility testing (similar to predicate).	"Device performance as a bone void filler of the skeleton system has been verified in animal studies using a rabbit femoral condyles model and through functional and biocompatibility testing."
Performance as a Bone Void Filler (Oral and Maxillofacial Region): Addressed by comparative testing in animal models and functional/biocompatibility testing (similar to predicate).	"Device performance as a bone void filler in the oral and maxillofacial region has been addressed by comparative testing in a sinus lift animal model study and through functional and biocompatibility testing."
Safety and Effectiveness: As safe and effective as the predicate device.	"Testing demonstrates that the proposed device is as safe and effective as the predicate device."
Resorption & Bone Growth Support: Resorbs while supporting in-growth of bone.	"Following placement in bony voids or gaps, TricOs A Resorbable Bone Substitute is resorbed while providing support for the in-growth of bone during the healing process." (This is stated in the Indication for Use and implies the device is expected to perform this function.)
Handling Characteristics: Favorable to facilitate surgical procedure.	"The fibrin matrix acts as a binder for the calcium phosphate scaffold, imparting favorable handling characteristics to the product to facilitate the surgical procedure..." (This relates to the device's design, not a performance metric that's 'proven' in a study described here, but rather a characteristic of the combined product.)

Detailed Study Information:

The document describes non-clinical studies to support substantial equivalence. It does not describe a clinical study in humans or a multi-reader multi-case (MRMC) comparative effectiveness study, as it's not a diagnostic AI device.

Sample size used for the test set and the data provenance:
- Test Set (Animal Studies):
  - Skeletal System: A "rabbit femoral condyles model" was used. The specific number of rabbits or defect sites is not specified in the provided text.
  - Oral and Maxillofacial Region: A "sinus lift animal model study" was used. The specific number of animals or sites is not specified in the provided text.
- Data Provenance: Animal studies. The country of origin of the data is not specified. The studies are assumed to be prospective as part of the device evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For animal studies, the "ground truth" would typically be based on histological analysis, imaging, and possibly biomechanical testing performed by veterinary pathologists, researchers, or specialists in orthopedics/maxillofacial surgery.
Adjudication method for the test set:
- This information is not provided.
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:
- No. This device is a bone void filler, not an AI-powered diagnostic tool. Therefore, an MRMC study is not applicable and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (bone substitute), not a software algorithm.
The type of ground truth used:
- For the animal studies, the "ground truth" likely involved:
  - Histology: Microscopic examination of tissue sections to assess bone formation, integration, and resorption of the material.
  - Imaging: X-rays, micro-CT scans, or other imaging modalities to assess bone density, defect filling, and integration.
  - Functional/Biocompatibility Testing: Assays to confirm non-toxicity and biological compatibility.
The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set" in the computational sense. The "training" for such a device involves product development, formulation, and manufacturing process optimization, not data-driven algorithmic training.
How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" in the context of AI/ML for this device. The "ground truth" for the predicate device's prior clearance and the current device's development would be based on established scientific and regulatory standards for biocompatibility, material properties, and performance in animal models.

Summary

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5. 510(K) SUMMARY			12081721
DATE:	June 16, 2008		AUG - 6 2008
OWNER:	Baxter Healthcare Corporation
	One Deerfield ParkwayDeerfield, IL 60015
CONTACT PERSON:	Barbara Barbeau
	Senior Director, Global Regulatory Affairs
	1620 Waukegan Road, MPGR-AL
	McGaw Park, IL 60085
	Telephone: 847-270-4174
	Fax: 847-785-5116
	Email: Barbara_Barbeau@baxter.com
DEVICE NAME:	Trade Name:	Tricos A¹ Resorbable BoneSubstitute
	Common Name	Bone Void Filler
	Classification Name:		Bone Grafting Material
	Class:	Class II
	Product Code:	LYC, NUN
PREDICATE DEVICES:	Previously cleared 510(k)s forBaxter Healthcare Corporation, Tricos TResorbable Bone Substitute product.
	Previous 510(k)	Indication	Clearance Date
	K051722	Bone void filling ofthe skeletal system	November 18, 2005
	K073571	Bone void filling of	April 8, 2008

the oral and

maxillofacial region

. .

1 TricOs A is a trademark of Baxter Healthcare Corporation

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DEVICE DESCRIPTION:

STATEMENT OF INTENDED USE:

TECHNOLOGICAL CHARACTERISTICS:

TricOs A Resorbable Bone Substitute for oral and maxillofacial region is substantially equivalent to Baxter's current legally marketed TricOs T Resorbable Bone Substitute cleared by 510(k) K073571 with regard to technological characteristics, performance, and intended use.

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ASSESSMENT OF NONCLINICAL DATA:

Baxter Heathcare conducted a risk assessment according to the requirements of ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices. The TricOs T and TricOs A device material and component specifications are similar. The device components continue to meet the same material testing standards and sterilization processing standards. Device performance as a bone void filler of the skeleton system has been verified in animal studies using a rabbit femoral condyles model and through functional and biocompatibility testing. Device performance as a bone void filler in the oral and maxillofacial region has been addressed by comparative testing in a sinus lift animal model study and through functional and biocompatibility testing.

CONCLUSIONS:

The proposed TricOs A Resorbable Bone Substitute has been verified against established standards and guidelines for its intended use. Testing demonstrates that the proposed device is as safe and effective as the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Barbara K. Barbeau Senior Director, Global Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road MP GR-AL McGaw Park, Illinois 60085

AUG - 6 2008

Re: K081721

Trade/Device Name: TricOs A"" Resorbable Bone Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Codes: LYC, NUN Dated: June 16, 2008 Received: June 18, 2008

Dear Ms. Barbeau:

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.

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Page 2 - Ms. Barbeau

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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) 276-0115. 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,

Wamuel-Land, mr for //

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K081721 New special 510(k)

Devicc Name:

TricOs A Resorbable Bone Substitute

Indication(s) for Use:

TricOs A Resorbable Bone Substitute is indicated for use as a bone void filler for voids and 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 A Resorbable Bone Substitute is intended to fill, augment, or reconstruct bony defects of the oral and maxillofacial region. Following placement in bony voids or gaps, TricOs A Resorbable Bone Substitute is resorbed while providing support for the ingrowth of bone during the healing process. TricOs A Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.

Susan Evans

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081721

Prescription Use: ☑	Over-the-Counter Use: ☐
21 CFR 801 Subpart D	21 CFR Subpart C

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 TricOs A is a trademark of Baxter Healthcare Corporation

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.