The Stryker Cross-Pinned Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendontibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.

Device Description

The Stryker Cross-Pinned Interference Screw consists of an implant and associated instruments for installation of the implant. The implant consists of two components: an interference screw and a cross pin. The interference screw has a transverse hole in it for receipt of the cross pin. The cross pin is available for optional use by the user, in the event that adjunctive fixation is deemed appropriate. A drill guide provides alignment for drilling a hole coincident with the hole in interference screw and for receiving the cross pin. Both implants will be provided sterile for single-use applications (ASTM 4169). These devices will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10 *. The devices are biocompatible per ISO-10993 and G95-1. The material of construction is Ti-6AI-4 V ELI per ASTM F136.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Stryker Cross-Pinned Interference Screw System, submitted to the FDA. This document focuses on demonstrating substantial equivalence to a predicate device, rather than outlining a detailed study with acceptance criteria in the manner typically seen for new diagnostic algorithms or AI devices.

Therefore, the following information is extracted or inferred from the text, recognizing that it is not a study design for evaluating algorithm performance, but rather a submission for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Intended Use	"intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patellar tendon-tibial bone graft complex, the semitendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft."	The device is described as having the same intended use as the predicate device.
Safety and Efficacy	"equivalent in intended use, safety, and efficacy to the predicate device."	"The cadaver testing showed a significant strength increase of both the yield load and the ultimate load." "Does not raise new issues when compared to the currently marketed predicate device." "It is considered substantially equivalent to the Stryker Wedge Interference Screw System."
Sterilization	"sterile for single-use applications (ASTM 4169)", "sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10⁻⁶".	Device will be provided sterile, sterilized by Gamma irradiation or Ethylene oxide, and validated to SAL of 10⁻⁶.
Biocompatibility	"biocompatible per ISO-10993 and G95-1".	Device is biocompatible per ISO-10993 and G95-1.
Material of Construction	Not explicitly stated as an "acceptance criterion" but a characteristic expected for the device.	Ti-6AI-4 V ELI per ASTM F136.

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

Test Set Sample Size: The text mentions "cadaver testing," but does not explicitly state the sample size (e.g., number of cadavers, number of screws tested).
Data Provenance: The cadaver testing is presumably laboratory-based testing, not clinical data from a specific country. The study is prospective in the sense that the testing was conducted specifically to evaluate this new device's performance against the predicate.

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

This information is not applicable to this submission. The "ground truth" for a physical device like an interference screw is its mechanical performance (yield load, ultimate load), not an expert interpretation of data.

4. Adjudication method for the test set

This information is not applicable. Mechanical testing results (yield load, ultimate load) are quantitative measurements, not subject to expert adjudication.

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 information is not applicable. This is a physical medical device, not an AI or diagnostic tool that requires human reader studies.

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

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

7. The type of ground truth used

The "ground truth" for the performance evaluation in this context is the mechanical load data (yield load and ultimate load) obtained from cadaveric testing. This is objective, quantitative physical measurement data.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable. This is a physical medical device, not an AI model.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

Device Name

Classification Name:

Smooth or Threaded Metallic Bone Fixation Fasteners: 21 CFR §888.3040, Class II Threaded Fixation Pin (87 JDW) Stryker Cross-Pinned Interference Screw

Common and Usual Name: Proprietary Name:

Predicate Device

Stryker Wedge Interference Screw (#K972233) currently marketed by Stryker Endoscopy (Santa Clara, CA).

Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.

The Stryker Cross-Pinned Interference Screw is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patellar tendon-tibial bone graft complex, the semitendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The interference screw fixation technique is a common method in orthopedic surgery, and has been well published in professional journals such as Arthroscopy: The Journal of Arthroscopic and Related Surgery.

Both implants will be provided sterile for single-use applications (ASTM 4169). These devices will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10 *. The devices are biocompatible per ISO-10993 and G95-1. The Stryker Cross-Pinned Interference Screw is equivalent in intended use, safety, and efficacy to the predicate device. The cadaver testing showed a significant strength increase of both the yield load and the ultimate load. The material of construction is Ti-6AI-4 V ELI per ASTM F136.

The Stryker Cross-Pinned Interference Screw System does not raise new issues when compared to the currently marketed predicate device. Therefore, it is considered substantially equivalent to the Stryker Wedge Interference Screw System.

Contact:

Date: July 10, 2001

Alisa Miller Quality Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, CA 95051 (408) 567-9100 x.2259

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2001

Ms. Alisa Miller Quality Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051

Re: K012270

Trade/Device Name: Stryker Cross-Pinned Interference Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JDW Dated: July 10, 2001 Received: July 19, 2001

Dear Ms. Miller:

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. Alisa Miller

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Mark N Milkersen

Celia M. Witten. Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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June 22, 2001

510(k) Number if known: K012270

INDICATION FOR USE:

(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 CFR 801.109) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Mark N. Mulhausen

Restorative and Neurological Devices 012270

510(k) Number_

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.