This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries. The Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT.

Device Description

The Sterling IF Screw Eyelet is manufactured from bovine bone processed with the BioCleanse® Tissue Sterilization Process. The Sterling IF Screw Eyelet is 25mm long by 8mm wide with an oval eyelet. The subject Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT cleared via K060253.

AI/ML Overview

This document describes the Sterling® IF Screw Eyelet, a soft tissue graft fixation device. However, the provided text does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices, not on performance criteria or specific studies.

Therefore, I cannot provide the requested information in the format specified. The information about the Sterling® IF Screw Eyelet is limited to:

Proprietary Name: Sterling® IF Screw Eyelet
Common Name: soft tissue graft fixation device
Product Code: HWC. Orthopedics Panel
Regulation Number: 21 CFR 888.3040 for Smooth or threaded metallic bone fixation fastener.
Description: Manufactured from bovine bone, processed with BioCleanse® Tissue Sterilization Process. 25mm long by 8mm wide with an oval eyelet. To be used with Sterling Interference Screw HT.
Intended Use: Graft fixation (e.g., ligament and tendon) in cruciate ligament reconstruction surgeries.
Substantial Equivalence: To LinX HT (design/function) and Sterling Interference Screw ST and Sterling Interference Screw HT (materials/function).
Material Source: Closed herd in the U.S.A.
Viral Inactivation Study: Worst-case representation of BioCleanse® process showed a reduction of a panel of viruses to below detectable limits.

To address each point of your request directly based on the provided text:

A table of acceptance criteria and the reported device performance: Not provided in the text.
Sample size used for the test set and the data provenance: Not provided in the text. (The mention of a viral inactivation study doesn't specify a "test set" in the context of device performance, nor does it provide sample size or provenance for general device acceptance.)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the text.
Adjudication method: Not provided in the text.
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 and not provided in the text. (This is not an AI-assisted device for diagnostic imaging or similar applications.)
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable and not provided in the text.
The type of ground truth used: Not provided in the text. (The viral inactivation study implies laboratory assay results for "ground truth" on viral reduction, but this is not about overall device performance acceptance criteria.)
The sample size for the training set: Not provided in the text.
How the ground truth for the training set was established: Not provided in the text.

Summary

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Regeneration Technologies, Inc. K063584 STERLING® IF Screw Evelet

510(K) Summarv

MAY - 9 2007

Date: May 4, 2007 Submitted by: Lisa Simpson Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 x4326 Fax: 386-462-1627

Proprietary Name: Sterling® IF Screw Eyelet

Common Name: soft tissue graft fixation device

Product Code: HWC. Orthopedics Panel

Code Section: 21 CFR 888.3040

Substantial Equivalence:

The Sterling IF Screw Eyelet is substantially equivalent to the LinX HT in design and function, and substantially equivalent to the Sterling Interference Screw ST and Sterling Interference Screw HT in materials and function.

Description:

Intended Use:

Summary of Technological Characteristics:

The Sterling IF Screw Eyelet, Sterling Interference Screw ST and Sterling Interference Screw HT are composed of the same materials processed in the same manner. The source of bovine bone used in the manufacture of the Sterling IF Screw Eyelet is a closed herd located in the U.S.A. A viral inactivation study using a worst-case representation of the BioCleanse® Tissue Sterilization Process, used in the manufacture of the Sterling IF Screw Eyelet, has shown a reduction of a panel of viruses to below detectable limits.

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Public Health Service

OF HEALTH & HUMAN SERVICES · USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Regeneration Technologies, Inc. % Ms. Lisa Simpson Director of Regulatory Affairs 11621 Research Circle Alachua, Florida 32616-2650

MAY - 9 2007

Re: K063584

Trade/Device Name: Sterling® IF Screw Eyelet Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, JDR Dated: April 20, 2007 Received: April 23, 2007

Dear Ms. Simpson:

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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Lisa Simpson

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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbari bucherp

Mark N. Melkerson 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): K063584

Device Name: Sterling® IF Screw Eyelet

Indications for Use:

Over-The-Counter Use 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)

Laubare Buckup
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K063584

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.