The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist and hand. Examples of such procedures include: Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs. Foot and Ankle: Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions. Elbow, Wrist and Hand: Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment. Knee: Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.

Device Description

The Smith & Nephew TwinFix Ti Quick T is a sterile single use anchor system which is designed to anchor suture to bone for the reattachment of soft tissue.

AI/ML Overview

The provided text is a 510(k) summary for the Smith & Nephew TwinFix Ti Quick T, a suture anchor device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI would.

Therefore, the information requested about acceptance criteria, device performance, study design, sample sizes, expert involvement, and ground truth establishment, is not present in this document because it describes a regulatory submission for a medical device that achieves clearance through substantial equivalence, not through a performance study against predefined acceptance criteria for AI or diagnostic accuracy.

Here's an explanation of why the requested information cannot be extracted from this specific document:

Type of Device: The Smith & Nephew TwinFix Ti Quick T is a suture anchor, a physical medical device. It is not an AI/ML algorithm or a diagnostic tool that produces outputs like classifications, segmentations, or risk scores that would be evaluated against diagnostic performance metrics (e.g., sensitivity, specificity, AUC).
Regulatory Pathway: The document describes a 510(k) premarket notification. This pathway typically demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics (material, design, intended use, sterilization, etc.), rather than conducting large-scale clinical performance studies with acceptance criteria in the way AI/diagnostic devices do.
Absence of Performance Data: The 510(k) summary explicitly states its purpose is to show "substantial equivalence in design, function, and intended use" to the predicate device K020159. It does not include any sections detailing:
- Specific acceptance criteria (e.g., "sensitivity must be > 90%").
- Reported device performance metrics (e.g., "achieved 92% sensitivity").
- Any form of clinical study or data analysis against a ground truth.
- Details about test sets, training sets, expert adjudication, or MRMC studies.

In summary, the provided document does not contain the information required to populate the requested table and answer the study-related questions for an AI/diagnostic algorithm because it pertains to a different type of medical device and regulatory clearance pathway.

Summary

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K02302/

SECTION V

OCT 0 4 2002

510(k) Summary

Smith & Nephew TwinFix Ti Quick T

Date Prepared: September 6, 2002

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

A. Submitter

Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810 508.261.3658

B. Company Contact

William McCallum Regulatory Specialist

C. Device Name

Trade Name:	Smith & Nephew TwinFix Ti Quick T
Common Name:	Suture AnchorSuture, Nonabsorbable, Polyester
Classification Name:	Screw, Fixation, Bone (HWC)

D. Predicate Device

Smith & Nephew TwinFix Ti Quick T, K020159

E. Description of Device

The Smith & Nephew TwinFix Ti Quick T is a sterile single use anchor system which is designed to anchor suture to bone for the reattachment of soft tissue.

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Page 2 of 2

F. Intended Use

Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs. Foot and Ankle:

Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon

repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions. Elbow, Wrist and Hand:

Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.

Knee:

Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.

G. Comparison of Technological Characteristics

The Smith & Nephew TwinFix Ti Quick T is substantially equivalent in design, function, and intended use to the following predicate device:

Smith & Nephew TwinFix Ti Quick T, K020159, March 26, 2002

i'll be there

William McCallum Regulatory Specialist

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized lines forming the body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

OCT 04 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William McCallum Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 130 Forbes Blvd. Mansfield, MA 02048

Re: K023021

Trade/Device Name: TwinFix™ Ti Quick-T Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 10, 2002 Received: September 11, 2002

Dear Mr. McCallum:

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 - Mr. William McCallum

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 vours.

Mark A. Millman

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

Enclosure

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510(k) Number:

Device Name: Smith & Nephew TwinFix Ti Quick T

Indications for Use :

· The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist and hand. Examples of such procedures include:

Shoulder:

Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions.

Elbow, Wrist and Hand:

Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, temnis elbow repair, and biceps tendon reattachment.

Knee:

(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (DE) Mark N Mille
(Division Sign-Off
Division of Gener Restorative
Neurological Devices

K023021

Labels	Values
510(k) Number
Over-the-Counter	No

Prescription Use (Per 21 CFR 801.109) OR

(Optional Format 1-2-96)

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.