The Smith & Nephew Titanium Interference Screws are available in various geometric configurations. The Smith & Nephew Titanium Interference Screws arc made with titanium alloy material. The range in diameters and lengths, combined with the variations in geometric configurations, provide the surgeon with a wide variety of sizes/configurations to choose from. Screws are available in both cannulated and non-cannulated styles. The screws may be purchased either sterile or non-sterile, to be sterilized by the end user.

AI/ML Overview

The provided text describes a 510(k) summary for Smith & Nephew Titanium Interference Screws. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data for acceptance criteria directly.

Here's an analysis of the provided text in relation to your requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds as one might expect from a rigorously designed clinical or performance study for a novel device. Instead, it relies on demonstrating substantial equivalence to predicate devices. The primary performance assertion is for mechanical properties.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical properties (insertion torque and pullout force) comparable to predicate devices.	Comparison of the results of the insertion torque testing and pullout force demonstrated that there were no statistically significant differences between the Smith & Nephew Titanium Interference Screw and the predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "insertion torque testing and pullout force" but does not specify the sample size used for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective nature). These tests appear to be bench or pre-clinical engineering tests rather than clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the provided document pertains to mechanical performance testing of an orthopedic implant rather than diagnostic accuracy or clinical interpretation studies involving expert human readers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reason as above. There is no mention of adjudication as it's not a diagnostic or clinical interpretation study.

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 is not applicable. This document describes an orthopedic implant (screws) and its mechanical performance compared to predicate devices. It does not involve AI or human reader performance.

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

This is not applicable, as the device is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical performance data (insertion torque and pullout force), the "ground truth" would be the measured values obtained from the specific testing methodologies (e.g., force gauges, torque meters) performed in a lab setting. The comparison is made against the performance of predicate devices, implying those predicate devices' performance serves as a benchmark for acceptable mechanical characteristics.

8. The sample size for the training set

This is not applicable. This is a 510(k) for an orthopedic implant, not a machine learning model, so there is no concept of a "training set" in this context.

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

This is not applicable for the same reason as above.

Summary

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SECTION IV

040331
page 1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMA

As required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Smith & Nephew Titanium Interference Screws

Date Prepared: February 6, 2004

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 130 Forbes Blvd., Mansfield, MA 02048

B. Company Contact

Denise Lima Regulatory Affairs Specialist Ph: (508)337-4036 Fax: (508)261-3620

C. Device Name

Trade Name:	Smith & Nephew Titanium Interference Screws
Common Name:	Screw, Fixation, Bone
Classification Name:	Smooth or threaded metallic bone fixation fastener

D. Predicate Devices

The Smith & Nephew Titanium Interference Screws are substantially equivalcnt in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: K895711 and K900132, Acufex Interference Screws; K932027, Oregon (Dyonics) Fixation System; K921481, Cannuflex Interference Screws.

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040331
page 2 of 2

Description of Device E.

Intended Use F.

The Smith & Nephew Interference Screws are used for fixation of ligaments and tendons in patients requiring ligament and tendon repair.

G. Comparison of Technological Characteristics

Although there are some dimensional variations between the Smith & Nephew Titanium Interference Screw and the predicate devices, there are no new issues raised concerning safety or efficacy of the device.

H. Summary Performance Data

Comparison of the results of the insertion torque testing and pullout force demonstrated that there were no statistically significant differences between the Smith & Nephew Titanium Interference Screw and the predicate devices.

Denise Lima 2/6/04
Denise Lima

Regulatory Affairs Specialist

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three wavy lines forming the body and head. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2004

Ms. Denise Lima Regulatory Affairs Specialist II Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover. Massachusetts 01810

Re: K040331

Trade/Device Name: Smith & Nephew Titanium Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 10, 2004 Received: February 12, 2004

Dear Ms. Lima:

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. Denise Lima

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 (301) 594-4659. 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 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.

Mair McMillan

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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Indications for Use

510(k) Number (if known):

510(k) Number (if known): K040231

Device Name: Smith & Nephew Titanium Screws

Indications For Use:

The Smith & Nephew Interference Screws are used for fixation of ligaments and tendons in patients requiring ligament or tendon repair.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Mark A. Millman

livision Division of General, Restorative. and Neurological Devices

510(k) Number K 040531

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.