TheriGraft™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriGraft™ putty creates a network within the defect site that resorbs during healing and is replaced by bone.

Device Description

The TheriGraft™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate granules (0.1 - 0.4 mm diameter) in a poloxamer based carrier.

AI/ML Overview

The provided text describes a 510(k) summary for TheriGraft™ TCP Putty Bone Void Filler, focusing on its substantial equivalence to a predicate device, Orthovita's Vitoss™. The study conducted is a pre-clinical animal study comparing the new device to the predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list "acceptance criteria" with specific numerical targets. Instead, it presents a comparison table (Table 1) that assesses the substantial equivalence of the new device (TheriGraft™) to the predicate device (Vitoss™) across various characteristics and attributes. The "reported device performance" is summarized as "similar results" in pre-clinical testing, leading to a determination of substantial equivalence (SE).

Characteristics or Attributes	Acceptance Criteria (Implied: Similarity to Predicate)	Reported Device Performance (TheriGraft™)
Indications for Use	Same as Vitoss™	Same
Intended Use	Same as Vitoss™	Same
Labeling	Same as Vitoss™	SE (Substantially Equivalent)
Target Population	Same as Vitoss™	Same
Design	Similar internal structures to Vitoss™	Similar internal structures
Materials	Same as Vitoss™	Same
Performance	Demonstrate performance characteristics (comparable to predicate)	Pre-clinical study demonstrated performance characteristics, "similar results" to Vitoss™
Sterility	Same as Vitoss™ (Gamma irradiation)	Same
Biocompatibility	Tested according to ISO 10993 (similar to predicate's compliance)	Product tested according to ISO 10993 (Unknown for Vitoss™ but implies compliance)
Chemical Safety	Tested according to ISO 10993 (similar to predicate's compliance)	Product tested according to ISO 10993 (Unknown for Vitoss™ but implies compliance)
Anatomical Sites	Same as Vitoss™	Same
Where Used	Same as Vitoss™	Same
Design Control	Verification & Validation (similar to predicate's compliance)	Design Controls: Verification & Validation (Unknown for Vitoss™ but implies compliance)

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

Sample Size: The document mentions a "canine animal model" but does not specify the number of animals used in the pre-clinical performance testing.
Data Provenance: The study was a "pre-clinical performance testing conducted on TheriGraft™ and Vitoss™ in a canine animal model." This indicates it was a prospective animal study. The country of origin of the data is not specified, but the submitting company is based in Princeton, NJ, USA.

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

This information is not provided in the document. The study was an animal model comparing the new device to a predicate device, and the evaluation criteria (tissue reaction, bone ingrowth, residual material, mechanical testing) would likely be assessed by veterinary pathologists or researchers with expertise in bone healing and material science. However, no details on the number or qualifications of experts are given.

4. Adjudication Method for the Test Set:

This information is not explicitly stated. "Adjudication method" is typically relevant in clinical studies where expert consensus is needed for ambiguous cases. In this pre-clinical animal study, the outcomes (tissue reaction, bone ingrowth, residual material, and mechanical testing) would likely be measured objectively or by a single expert/team following a predefined protocol.

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:

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI assistance on human reader performance, which is not applicable to a pre-clinical animal study of a bone void filler material.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

No. This is not an AI/algorithm-based device. It is a physical bone void filler. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used:

The ground truth was established through pre-clinical animal model outcomes, specifically:

Tissue reaction: Histological analysis of surrounding tissues.
Bone ingrowth: Histological and potentially imaging analysis of new bone formation.
Residual material: Assessment of the remaining implanted material.
Mechanical testing: Evaluation of the strength and integrity of the healed bone.

These are objective biological and biomechanical measures derived from the animal model.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The device is a physical bone void filler, not an AI model that requires a training set. The study describes pre-clinical testing, not algorithm development.

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

This information is not applicable/not provided as there is no training set for an AI model. For the pre-clinical study, the outcomes listed in point 7 served as the ground truth.

Summary

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THERICS, LLC. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 609-514-0255 FAX: E-MAIL: therics(@therics.com

JAN 3 ] 2006

THERICS HEFERENG SPREFIALISTS

510(k) SUMMARY

Therics' TheriGraft™ Bone Void Filler

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Submitter's Name:

Sunil Saini

609.514.7200 x7262 or 609.514.7200 (main) Telephone: Facsimile: 609.514.0255 Contact Person: Sunil Saini

Date Prepared: November 1, 2005

Name of Device and Name/Address of Sponsor

TRADE/PROPRIETARY NAME OF DEVICE:

TheriGraft™ TCP Putty Bone Void Filler

ADDRESS:

115 Campus Drive Princeton, New Jersey 08540

Common or Usual Name:

Bone Void Filler. Synthetic Bone Void Filler. Synthetic Cancellous Bone Void Filler. Bone Graft Substitute. Synthetic Bone Substitute. Synthetic Cancellous Bone Substitute.

Classification Name

Bone Void Filler

Predicate Device

Orthovita's Vitoss™

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THERICS, L.L.C. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 FAX: FAX: --------------------------------------------------------------------------------------------------------------------------------------------------------------------609-514-0255 E-MAIL: therics@therics.com

Image /page/1/Figure/1 description: The image shows the logo for THERICS. The logo features a stylized letter "T" made of plus signs. Below the "T" is the word "THERICS" in a stylized font, and below that are the words "ENGINEERING SPECIALISTS" in a smaller font.

Intended Use / Indications for Use

TheriGraft™ TCP Putty Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriGraft™ putty creates a network within the defect site that resorbs during healing and is replaced by bone.

Technological Characteristics and Substantial Equivalence

The TheriGraft™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate granules (0.1 - 0.4 mm diameter) in a poloxamer based carrier.

Pre-clinical performance testing conducted on TheriGraft™ and Vitoss™ in a canine animal model according to indication yielded similar results based on tissue reation, bone ingrowth, residual material, and mechanical testing. TheriGraft™ bone void filler has the same intended use and indications, the same or similar principles of overation and technological characteristics, and equivalent performance in an appropriate animal model. Therefore, TheriGraff™ Bone Void Filler is substantially equivalent to the predicate device (see Table 1).

Attachment - 6 Page 3 of 4

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THERICS, LLC. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 FAX: 609-514-0255 E-MAIL: therics@therics.com

Image /page/2/Picture/1 description: The image shows the logo for "THERICS". The logo consists of a stylized letter "T" made up of plus signs, with the word "THERICS" written in a blocky, sans-serif font below it. Underneath the company name are the words "TISSUE ENGINEERING SPECIALISTS" in a smaller, sans-serif font. The logo is simple and modern, with a focus on the company's name and area of expertise.

Characteristicsor Attributes	TheriGraft™(NEW)	Vitoss ™K994337	Comments
Indications for Use	Indicated for use in fillingthe gaps or voids of osseousdefects surgically created orresulting from trauma.TheriGraft™ may be usedwith autogenous bonemarrow	Indicated for use in fillingthe gaps or voids of osseousdefects surgically created orresulting from trauma.Vitoss may be used withautogenous bone marrow	Same
Intended Use	Intended for treatment ofosseous defects not intrinsicto the stability of the bonestructure. The product isintended for use in defects ofthe skeletal system (i.e., theextremities, spine andpelvis).	Intended for treatment ofosseous defects not intrinsicto the stability of the bonestructure. The product isintended for use in defectsof the skeletal system (i.e.,the extremities, spine andpelvis).	Same.
Labeling	See Indications for Use andIntended Use.	See Indications for Use andIntended Use.	SE.
Target Population	Patients with osseous defectssurgically created orresulting from trauma.	Patients with osseousdefects surgically created orresulting from trauma.	Same.
Design	Porous trabecular structuressimilar to cancellous bone.Approximately 0.1 – 0.4 mmgranules.	Porous trabecular structuressimilar to cancellous bone.1 – 4 mm granules.	Similar internal structures forTheriGraft & Vitoss.Granule dimensions aredifferent.
Materials	Calcium salt; β-tricalciumphosphate mineral phase inpoloxamer carrier.	Calcium salt; β-tricalciumphosphate mineral phase.	Same.
Performance	Pre-clinical study todemonstrate performancecharacteristics.	Pre-clinical study todemonstrate performancecharacteristics.	SE.
Sterility	Gamma irradiation.	Gamma irradiation.	Same.
Biocompatibility	Product tested according toISO 10993, BiologicalEvaluation of MedicalDevices.	Unknown.	Same.
Chemical Safety	Product tested according toISO 10993, BiologicalEvaluation of MedicalDevices.	Unknown.	Same.
Anatomical Sites	Osseous defects not intrinsicto the stability of the bonestructure.	Osseous defects not intrinsicto the stability of the bonestructure.	Same.
Where Used:Hospital, home,ambulance, etc.	Hospital or Health CarePractitioner’s surgical suite.	Hospital or Health CarePractitioner’s surgical suite.	Same.
Design Control	Design Controls:Verification & Validation	Unknown.	SE.

Table 1: TheriGraft™ & Vitoss™ SE and Comparison Chart

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Image /page/3/Picture/0 description: The image shows a logo for a company called "THERICS'." The logo features a stylized letter "T" formed by a series of plus signs. Below the company name, there is some text that is difficult to read due to the image quality, but it appears to say "TISSUE ENGINEERING SPECIALISTS."

CONFIDENTIAL

Attachment - 12

Indications for Use Form

510(k) Number (if known): Not assigned at this time

Device Name:

TheriGraft™ TCP Putty Bone Void Filler

Indications for Use:

TheriGraft™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e., the extremities, spine and pelvis). TheriGrafTM parts create a network within the defect site that resorbs during healing and is replaced by bone

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C.F.R. 801.109)

Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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Image /page/4/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2006

Sunil Saini, Ph.D. Director, Biomaterials THERICS, LLC. 115 Campus Drive Princeton, New Jersey 08540

Re: K053228

Trade/Device Name: TheriGraft™ TCP Putty 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 16, 2005 Received: November 21, 2005

Dear Dr. Saini:

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 sct 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 -- Sunil Saini, Ph.D.

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,

sincerely yours,

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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Indications for Use

510(k) Number (if known): Ko5 3228

Device Name:_Therigraft™ TCP Putty Bone Void Filler

Indications For Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

KOS3228

Page 1 of 1

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.