TheriFil™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and 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). TheriFil™ parts create an interlocking network within the defect site that resorbs during healing and is replaced by bone.

Device Description

The TheriFil™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate, a commonly found mineral in bone. The porosity and geometric features of B-tricalcium phosphate create an interlocking network within the defect site that resorbs during healing and is replaced by native bone.

AI/ML Overview

Here's an analysis of the provided text regarding the TheriFil™ Bone Void Filler, focusing on the acceptance criteria and the study that proves the device meets those criteria:

The provided document is a 510(k) summary for the TheriFil™ Bone Void Filler, seeking substantial equivalence to predicate devices (Orthovita's Vitoss™ and Wright Medical's WMT-TCP Bone Graft Substitute). It establishes substantial equivalence by comparing technological characteristics and performance in a preclinical animal model.

Here's the breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for clinical performance. Instead, it demonstrates substantial equivalence to a predicate device based on similar technological characteristics and equivalent performance in a preclinical animal model. The "acceptance criteria" can be inferred to be that the TheriFil™ device performs equivalently to the predicate device in the assessed parameters.

Characteristic	Acceptance Criteria (Implied: Equivalent to Vitoss™)	Reported Device Performance (TheriFil™)
Porosity	~80%	~60%
Pore Area (µm²) - Mean	$2700 \pm 2200$	$3000 \pm 1200$
Pore Area (µm²) - Min	40	40
Pore Area (µm²) - Max	$5.7x10^5 + 3.3x10^5$	$3.5x10^5 + 2.1x10^5$
Pore Diameter (µm) - Mean	$56 \pm 19$	$60 \pm 12$
Pore Diameter (µm) - Min	7	7
Pore Diameter (µm) - Max	$810 \pm 270$	$640 \pm 220$
True Density (grams/mL)	$1.527 \pm 0.002$	$1.530 \pm 0.001$
Bulk Packing Density (grams/mL)	$0.22 \pm 0.02$	$0.53 \pm 0.02$
Packing Porosity (%)	$85.8 \pm 1.0$	$65.7 \pm 1.4$
Pre-clinical performance (tissue reaction, bone ingrowth, residual material, mechanical testing)	Similar to Vitoss™	Similar to Vitoss™

Note: While some physical characteristics show differences (e.g., porosity, bulk packing density, packing porosity), the overall conclusion is that the technological characteristics are "the same or similar" and preclinical performance is "equivalent." The specific numerical bounds for "similar" or "equivalent" are not defined as strict acceptance criteria in this document.

2. Sample size used for the test set and the data provenance

Physical/Chemical Characteristics (Table 1):
- Sample Size: "n = 30" for SEM images used to estimate porosity and pore area/diameter. For true density, bulk packing density, and packing porosity, sample sizes are not explicitly stated as 'n=30', but derived from methods described in Attachments 13A and 13B.
- Data Provenance: The document does not specify the country of origin. It is a submission to the FDA in the USA. The data would be considered retrospective in the context of this 510(k) submission, as it's data collected to support the submission.
Pre-clinical Performance Testing:
- Sample Size: Not explicitly stated, but performed "in a canine animal model." The number of animals or implants is not provided.
- Data Provenance: Conducted in a canine animal model. Implied to be retrospective for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document does not describe the use of human experts to establish "ground truth" for the test set in the way one might for diagnostic imaging devices. The "ground truth" for the physical characteristics is established by direct measurement (e.g., SEM, pycnometer). For the preclinical animal model, the assessment of tissue reaction, bone ingrowth, residual material, and mechanical testing would typically be performed by veterinary pathologists, researchers, or mechanical engineers with expertise in these areas, but the document does not specify their number or qualifications.

4. Adjudication method for the test set

Not applicable. The data presented are objective measurements and preclinical study results, not subject to human interpretation requiring adjudication in the context of this document.

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

Not applicable. This is a medical device (bone void filler), not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

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

For physical/chemical characteristics: The ground truth is based on direct physical and chemical measurements (e.g., microscopy for porosity, pycnometry for density).
For preclinical performance: The ground truth is based on histopathological evaluation (tissue reaction, bone ingrowth, residual material) and mechanical testing in a canine animal model.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a "training set." The development of the TheriFil™ device and the selection of its material properties would have been based on scientific understanding of bone biology and material science, but this doesn't constitute a "training set" in the context of an algorithm.

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

Not applicable, as there is no "training set" in the machine learning sense. The material properties were designed and characterized based on scientific principles and existing knowledge of what constitutes an effective bone void filler, with "ground truth" in this context being established by scientific understanding and experimental validation of material properties and biological response.

Summary

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JUL 2 4 2003

K 03/090

Attachment - 6

510(k) Summary

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THERICS, INC. 115 CAMPUS DRIVE RINCETON, NJ 0854 ELEPHONE: 609-514-7200 609-514-7219 FAX: E-MAIL: therics@therics.com

Image /page/1/Picture/1 description: The image contains the word "THERICS" in a stylized font. To the left of the word is a pattern of black dots arranged in a grid-like fashion. Above the word, there is some handwritten text that appears to be "K03/040". There is also the number "03" on the left side of the image.

JUL 2 4 2003

510(k) SUMMARY

Therics' TheriFil™ Bone Void Filler

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

Submitter's Name:

Umberto V. Parrotta

609.514.7237 or 609.514.7200 (main) Telephone: Facsimile: 609.514.7219 Contact Person: Umberto V. Parrotta

Date Prepared:March 31, 2003

Name of Device and Name/Address of Sponsor

TRADE/PROPRIETARY NAME OF DEVICE:

TheriFil™ 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 Devices

Orthovita's Vitoss™ Wright Medical's WMT-TCP Bone Graft Substitute

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THERICS, INC. 15 CAMPUS DRIVE RINCETON, NJ 08540 TELEPHONE: 609-514-7200 609-514-7219 FAX' E-MAIL: therics@therics.com

Image /page/2/Picture/1 description: The image shows the word "THERICS" next to a square made up of circles. The circles are arranged in a grid pattern, with the circles on the left side of the square being lighter and the circles on the right side of the square being darker. The word "THERICS" is written in a sans-serif font and is slightly offset to the right of the square. The image is black and white.

Intended Use / Indications for Use

Technological Characteristics and Substantial Equivalence

A summary of the physical and chemical characteristics of both TheriFilTM and Vitoss™ is below in Table 1.

Characteristic		TheriFilTM	VitossTM
Porosity		~60%	~80%
Pore Area (µm2)	Mean	$3000 \pm 1200$	$2700 \pm 2200$
	Min*	40	40
	Max	$3.5x10^5 + 2.1x10^5$	$5.7x10^5 + 3.3x10^5$
Pore diameter (µm)	Mean	$60 \pm 12$	$56 \pm 19$
	Min*	7	7
	Max	$640 \pm 220$	$810 \pm 270$
True Density (grams/mL)		$1.530 \pm 0.001$	$1.527 \pm 0.002$
Bulk Packing Density (grams/mL)		$0.53 \pm 0.02$	$0.22 \pm 0.02$
Packing Porosity (%)		$65.7 \pm 1.4$	$85.8 \pm 1.0$

Table 1. Physical characteristics of the TheriFil™ and Vitoss™ bone void fillers.

Percent porosity and pore area (um") were estimated using SEM images (n = 30) and are described in Attachment 134, Porosity Characterization. Data are shown as ave + stdev. The pore diameter was estimated from the pore area by assuming circular shaped pores. *All finite (< 40 um') pore structures were excluded from the analysis and therefore the minimum pore area is represented by 40um² and the pore diameter by 7um. The true density was measured using a pycnometer. Methods describing bulk packing porosity and described in Attachment - 13B, Implant Packing Characterization.

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Image /page/3/Picture/1 description: The image shows the word "THERICS" in a stylized font, with a pattern of black circles to the left of the word. The circles are arranged in a grid-like pattern, with the density of the circles decreasing from left to right. The word "THERICS" is in a sans-serif font, and the letters are slightly distorted, giving them a textured appearance. The overall effect is modern and technological.

Pre-clinical performance testing conducted on TheriFil™ and Vitoss™ in a canine animal model according to indication yielded similar results based on tissue reaction, bone ingrowth, residual material, and mechanical testing.

The TheriFil™ implants have the same intended use and indications, the same or similar principals of operation and technological characteristics, and equivalent performance in an appropriate animal model. Therefore, Theric's TheriFil™ Bone Void Filler is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with wavy lines below them.

Public Health Service

JUL 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Umberto V. Parrotta, Jr. 115 Campus Drive Therics, Inc. Princeton, NJ 08540

Re: K031040

Trade Name: TheriFil Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: March 31, 2003 Received: April 1, 2003

Dear Mr. Parrotta:

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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Page 2 – Mr. Umberto V. Parrotta, Jr.

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 vours,

Sincerely yours,

Mark N Millenson

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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CONFIDENTIAL

Attachment - 12

Indications for Use Form

510(k) Number (if known): K031040.

Device Name:

TheriFil™ Bone Void Filler

Indications for Use:

TheriFil™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and 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). TheriFil™ parts create an interlocking 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)
	(Division Sign-on)
	Division of Ge Restorative and Neurological Devices
510(k) Number	K031040
Prescription Use (Per 21 C.F.R. 801.109)✓	OR	Over-The-Counter Use

(Optional Format 1-2-96)

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.