The STERLING® Interference Screw HT is intended for use in an arthroscopic or open ACL and/or PCL reconstruction by a trained medical professional.
The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendonbone graft; fixation during posterior cruciate ligament reconstruction utilizing a bone-tendon-bone graft.

Device Description

The STERLING® Interference Screw HT is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw HT is threaded and has an external squared-drive.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the STERLING® Interference Screw HT, a bone fixation screw made from processed bovine cortical bone. This document focuses on demonstrating substantial equivalence to a predicate device and includes details about an animal study and a viral inactivation study.

However, the information required for a comprehensive acceptance criteria and study description, particularly in the context of device performance metrics and evaluation methodology (like sample sizes, ground truth establishment, expert qualifications, and MRMC studies often associated with AI/software devices), is not present in the provided text.

The primary acceptance criteria and performance data available are related to comparability of remodeling in an animal model and viral inactivation efficiency. There are no reported device performance values in terms of statistical metrics (sensitivity, specificity, accuracy, etc.) because this is a physical medical device (a screw), not a diagnostic algorithm or AI.

Here's a breakdown of what can be extracted and what is missing based on your request:

Acceptance Criteria and Study for STERLING® Interference Screw HT

Given that the device is a physical bone fixation screw, the "acceptance criteria" and "device performance" in this context refer to biological and safety aspects rather than diagnostic or AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Biological Performance	Comparable remodeling to allograft	Shown to remodel comparably to allograft
Safety (Viral Inactivation)	Reduction of panel of viruses to below detectable limits, with greater than six log reduction	Achieved greater than a six log reduction of a panel of viruses to below detectable limits

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

Animal Model: The text states "in an animal model" but does not specify the sample size (number of animals or implants) or the species used for the remodeling study.
Viral Inactivation Study: The text refers to "a viral inactivation study" but does not specify the sample size (number of tests or replicates) or the specific viruses in the "panel of viruses."
Data Provenance: The animal study and viral inactivation study are likely prospective studies conducted specifically for this submission. The text doesn't specify the country of origin for the studies, but the device is manufactured from bovine bone from a "closed herd located in the U.S.A."

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 text. For a physical device like a screw, "ground truth" would typically refer to histopathological analysis for remodeling or detailed laboratory assays for viral inactivation. The expertise would lie with veterinary pathologists, microbiologists, and other laboratory scientists.

4. Adjudication Method for the Test Set

This information is not provided in the text. Methods like 2+1 or 3+1 adjudication are typically relevant for human-interpreted data (e.g., radiology reads), which is not the case here.

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, an MRMC comparative effectiveness study was not done. This type of study is specific to AI/software devices that assist human readers in diagnostic tasks. The STERLING® Interference Screw HT is a physical medical device.

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

No, a standalone performance study in the context of an algorithm's performance was not done. This is not applicable to a physical medical device.

7. The Type of Ground Truth Used

Biological Performance (Remodeling): Implied ground truth would be histology and biological markers assessed in the animal model.
Safety (Viral Inactivation): Ground truth would be established through laboratory viral assays determining the presence and quantity of infectious viral particles.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of a physical device or an AI algorithm.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the reasons stated above.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (a bone screw) by comparing its material, design, and function to a predicate device, and by presenting evidence of its biological remodeling capacity and viral inactivation safety through an animal study and a viral study, respectively. It does not contain information related to AI or diagnostic performance metrics, expert evaluation, or ground truth establishment in the way these terms are typically used for AI-based devices.

Summary

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K052405 page 142

NOV 1 6 2005

510(K) Summary

Date: August 31, 2005

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

Proprietary Name: STERLING® Interference Screw HT

Common Name: Screw, fixation, bone

Classification: HWC, orthopedics panel

Code Section: 21 CFR 888.3040

Substantial Equivalence:

The STERLING® Interference Screw HT is equivalent to the STERLING® Interference Screw ST in materials, design, and function.

Description:

Intended Use:

The STERLING® Interference Screw HT is intended for use in an arthroscopic or open ACL and/or PCL reconstruction by a trained medical professional.

Summary of Technological Characteristics:

The STERLING® Interference Screw HT and the STERLING® Interference Screw ST have equivalent materials, design and function. The STERLING® Interference Screw HT is constructed of bovine bone and is equivalent in materials to another 510(k)-cleared product, the STERLING® Interference Screw ST. The source of bovine bone used in the manufacture of STERLING® Interference Screw HT is a closed herd located in the U.S.A.

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The STERLING® Interference Screw HT has been shown to remodel comparably to allograft in an animal model. A viral inactivation study using a worstory to
representation of the BioCleanse® process, used in the manifacture of STERLING® Interference Screw HT, has shown greater than a six log reduction of a panel of viruses to below detectable limits.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a river or stream. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2005

Ms. Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle P.O. Box 2650 Alachua, Florida 32615

K052405 Trade/Device Name: Sterling® Interference Screw HT Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 31, 2005 Received: September 13, 2005

Dear Ms. Hartill:

Re:

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 may be obtained 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,

C.C. McMullen

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

Enclosure

_ 注

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Regeneration Technologies, Inc. STERLING® Interference Screw HT 510(k) Pre-market Notification

Indications for Use

510(k) Number (if known): K052405

Device Name:

STERLING® Interference Screw HT

Indications for Use: The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendonbone graft; fixation during posterior cruciate ligament reconstruction utilizing a bone-tendon-bone graft.

Over-The-Counter Use No Prescription 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)

KJS 2405

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

519(k) Number上のメイン

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.