STERLING® Cancellous Chips and STERLING® Cancellous Cubes are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

Device Description

STERLING® Cancellous Chips and STERLING® Cancellous Cubes are manufactured from bovine bone processed with the BioCleanse" Tissue Sterilization Process. STERLING® Cancellous Chips and STERLING® Cancellous Cubes are provided in 1-10mm sizes, with 15-90cc per package.

AI/ML Overview

This document, a 510(k) summary for the STERLING® Cancellous Chips and STERLING® Cancellous Cubes, does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

This submission is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device (PolyGrafi™ BGS). The information provided focuses on the device's description, intended use, and a summary of technological characteristics, rather than a detailed performance study with acceptance criteria.

However, based on the provided text, I can extract what is mentioned:

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

This document does not present a formal table of acceptance criteria nor specific quantitative performance metrics. Instead, it makes two qualitative claims about performance:

Acceptance Criteria (Implied)	Reported Device Performance
Remodel comparably to allograft	"STERLING® Cancellous Chips and STERLING® Cancellous Cubes have been shown to remodel comparably to allograft in an animal model."
Viral inactivation efficacy	"A viral inactivation study...has shown a greater than six log reduction of a panel of viruses."

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

Animal Model for Remodeling: The document mentions an "animal model" but provides no information on the sample size used, the specific type of animals, the country of origin, or whether the study was retrospective or prospective.
Viral Inactivation Study: The document mentions a "viral inactivation study" but provides no information on the sample size (e.g., number of replicates, types of viruses), the country of origin for the data, or its retrospective/prospective nature.

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 in the document for either the animal model or the viral inactivation study. The concept of "ground truth" as typically defined in AI/diagnostic studies (e.g., expert consensus on images or pathology confirmation) is not applicable here, as these are material science and biological efficacy studies.

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

This information is not applicable to the types of studies mentioned (animal model for remodeling, viral inactivation study), which typically involve laboratory measurements and histological/virological analyses rather than interpretation by multiple human readers.

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 is not applicable. The device is a bone void filler, not an AI diagnostic tool. Therefore, an MRMC study is irrelevant.

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

This is not applicable. The device is a physical medical device, not an algorithm.

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

Animal Model for Remodeling: The "ground truth" would likely be based on histological analysis and potentially imaging (e.g., X-ray, micro-CT) of bone formation and integration in the animal model, compared to allograft.
Viral Inactivation Study: The "ground truth" would be based on quantitative virological assays to measure the reduction in viral titer after exposure to the BioCleanse® process.

8. The sample size for the training set:

This is not applicable. The document describes a physical medical device and its processing, not an algorithm that requires a training set.

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

This is not applicable for the reasons stated in point 8.

Summary

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. . . 11621 Research Circle ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Alachua, FL 32616-2650 USA

Tel 386.418.8888 Toll Free 877.343.683 Fax 386.418.0342 www.rtix.com

AUG 1 5 2005

510(K) Summary

K051615 Date: August 5, 2005

Submitted by: Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 x4382 Fax: 386-462-3821

Proprictary Name: STERLING® Cancellous Chips STERLING® Cancellous Cubes

Common Name: Filler, bone void, calcium compound

Classification: MQV, Orthopedics Panel

Code Section: 21 CFR 888.3045

Substantial Equivalence:

STERLING" Cancellous Chips and STERLING" Cancellous Cubes are substantially equivalent to PolyGrafi™ BGS in design and function, and are composed of bovine bone processed in the same manner as the STERLING* Interference Screw ST.

Description:

STERLING® Cancellous Chips and STERLING* Cancellous Cubes are manufactured from bovine bone processed with the BioCleanse" Tissue Sterilization Process. STERLING® Cancellous Chips and STERLING® Cancellous Cubes are provided in 1-10mm sizes, with 15-90cc per package.

Intended Use:

STERLING* Cancellous Chips and STERLING* Cancellous Cubes are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created

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osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

Summary of Technological Characteristics:

STERLING® Cancellous Chips, STERLING® Cancellous Cubes, and PolyGraft™ BGS have substantially equivalent design and function, but are composed of different materials. The STERLING® Cancellous Chips and STERLING* Cancellous Cubes are constructed of bovine bone processed in the same manner as the STERLING* Interference Screw ST. The source of bovine bone used in the manufacture of STERLING® Cancellous Chips and STERLING® Cancellous Cubes is a closed herd located in the U.S.A.

STERLING® Cancellous Chips and STERLING* Cancellous Cubes have been shown to remodel comparably to allograft in an animal model. A viral inactivation study using a worst-case representation of the BioCleanse® process, used in the manufacture of STERLING® Cancellous Chips and STERLING® Cancellous Cubes, has shown a greater than six log reduction of a panel of viruses.

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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 wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

AUG 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle Alachua, Florida 32615

Re: K051615

Trade/Device Name: STERLING® Cancellous Chips STERLING® Cancellous Cubes Regulation Number: 21 CFR 888.3045 Regulation Name: Reabsorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 5, 2005 Received: August 8, 2005

Dear Ms. Hartill:

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 - Ms. Carrie Hartill

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 A. Milken

Mark 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): STERLING® Cancellous Chips Device Name: STERLING® Cancellous Cubes Indications for Use: STERLING® Cancellous Chips and STERLING® Cancellous Cubes are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

Prescription Use Over-The-Counter Use x AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Mark A. Millman

ivision Sign-Off) Triston of General, Restorative Id Neurological

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.