The subject device, TwinFix® Interfragmentary Compression Screw System is Indicated for fractures or arthrodesis of carpais and metacarpals, radial styloid fractures, metatarsal fractures and ostectornies of the forefoot and intra-articular arthrodesis in the wrist.

The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is intended to be used for fractures or arthrodesis of carpals and metacarpals, radial head and radial styloid fractures, metatarsal fractures and osteotomies of the forefoot and intra-articular arthrodesis in the wrist.

Device Description

The Stryker Leibinger, TwinFix® Interfragmentary Compression Screw System is indicated for the treatment of fractures, psueudo-arthrosis, degenerative alterations and corrective osteotomies alming to a functionally stable osteosysntheis such as, but not limited to: scaphoid fractures, fractures of other carpal bones, scaphoid pseudo-arthrosis, intercarpal arthrodesis of finger end and metacarpal joints and fractures of ulna head and radius head. The TwinFix® is a double cancellous bone thread screw system that is designed for in situ dynamic adjustable interfragmentary compression purposes. It has a self-tapping screw tip design with varying lengths. It may be placed using an open approach with the use of a target bow device for placement of screws or through percutaneous screw placement using K-virre as a guide to minimize the incision.

AI/ML Overview

The provided text describes a 510(k) summary for the TwinFix® Interfragmentary Compression Screw System, which is a medical device for bone fixation. However, it does not contain any information regarding acceptance criteria, device performance metrics, or a study that proves the device meets specific acceptance criteria.

The document primarily focuses on:

Device Identification: Proprietary name, common name, regulatory class, submitter, manufacturer, contact person.
Intended Use: Specific indications for which the device is designed (e.g., fractures of carpals, metacarpals, radial styloid, metatarsals, osteotomies of the forefoot, intra-articular arthrodesis in the wrist).
Device Description: A brief overview of the screw system, its design (double cancellous bone thread screw, self-tapping), and placement methods (open approach with target bow, percutaneous with K-wire).
Substantial Equivalence: A statement that the device is "identical to K961498, Resch Arthroscopic and Percutaneous Screw Fixation System in all respects of fixations of small bones." This is a key part of the 510(k) process, demonstrating that the new device is as safe and effective as a legally marketed predicate device.
FDA Clearance Letter: Correspondence from the FDA stating that the device has been found substantially equivalent to predicate devices and can be marketed.

Since the document is a 510(k) summary and not a clinical study report or a detailed design validation document, it does not include the granular information requested about acceptance criteria and empirical performance testing. 510(k) submissions typically rely on established performance of predicate devices and bench testing to demonstrate substantial equivalence, rather than new, extensive clinical studies for performance metrics like those for AI/ML devices.

Therefore, for your specific questions:

A table of acceptance criteria and the reported device performance: This information is not available in the provided text.
Sample sized used for the test set and the data provenance: Not applicable, as no performance study is described with a test set. The substantial equivalence is based on the predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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, as this is a mechanical bone fixation device, not an AI/ML diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided excerpt describes the regulatory clearance of a medical device based on substantial equivalence, not a detailed performance study with explicit acceptance criteria and results.

Summary

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K∅13775
PG 1 OF 2

Jan 8 2002

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: TwinFix® Interfragmentary Compression Screw System

Proprietary Name:	TwinFix® Interfragmentary Compression Screw System
Common Name:	Small Bone Screw SystemSingle/Multiple Component Metallic Bone FixationApplication and Accessories 888.3030Target Bow InstrumentationOrthopedic manual surgical instrument21 CFR 888.4540 Class I exempt
Proposed Regulatory Class:	Class II
Device Classification:	87 HRS87 LXH
Submitter:	Stryker Leibinger4100 East Milham AvenueKalamazoo, MI 49001800-253-7370
Submitter's Registration #:	1811755
Manufacturer's Registration #:	8010177
Contact Person:	Robin L. RoweRegulatory Affairs RepresentativeTelephone: 877-534-2464 x3295Fax: 616-324-5458
Summary Preparation Date:	November 01, 2001

510(K) Summary of Safety and Effectiveness TwinFix® Interfragmentary Compression Screw System 1

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013775

Intended Use

See Appendix C for equivalency.

Device Description

Substantial Equivalence

The TwinFix® Interfragmentary Compression Screw is Identical to K961498, Resch Arthroscopic and Percutaneous Screw Fixation System in all respects of fixations of small bones. A table of eguivalency is provided in Appendix C.

Robin L Rowe

Regulatory Affairs Representative December 20, 2001

510(K) Summary of Safety and Effectiveness TwinBix® Interfragmentary Compression Screw System 2

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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 8 2002

Stryker Leibinger Robin L. Rowe Regulatory Affairs Representative 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K013775

Trade Name: Twinfix Interfragmentary Compression Screw System Regulation Number: 888.3030 Regulation Name: Compression Screw with accessories Regulatory Class: II Product Code: HRS Dated: December 7, 2001 Received: December 11, 2001

Dear Ms. Rowe:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 注 Ms. Robin Rowe

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 promated 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,

Celia M. Witten, Ph.D., M.D.
Director

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

Enclosure

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KO13775

510(k) Number (if known):

Page 1 of 1

Device Name: TwinFix® Interfragmentary Compression Screw System

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)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off) Division of General. Pastorative and Neurolegican Bookes

510(k) Number K013775

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.