The Smith & Nephew GTS Sleeve and GTS Tapered Screw consist of two (2) components, the sleeve and screw. The sleeve manages, protects, and separates the graft tendon bundle and creates a central path for concentric placement of the tapered screw, which forces a larger surface area of the tendons against the tibial tunnel wall within a surgically created tunnel.

AI/ML Overview

Here's an analysis of the provided information, focusing on acceptance criteria and a study to prove device performance:

Based on the provided text, the device in question is "The Smith & Nephew GTS Sleeve and GTS Tapered Screw". This document is a 510(k) Summary of Safety and Effectiveness, which is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a clinical or stand-alone performance study in the way a newer, non-equivalent device might.

Therefore, many of the requested points regarding sample sizes, ground truth, expert opinions, and MRMC studies are not explicitly detailed in this type of submission. The performance here is assessed by comparing technological characteristics and "in vitro performance testing" to establish equivalence.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" is not explicitly defined in terms of specific performance metrics (e.g., tensile strength, fixation force) with corresponding pass/fail thresholds in this summary. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance data supports this equivalence.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Summary)
1. Same Intended Use: The device must be indicated for the same use as the predicate devices.	Met: "The Smith & Nephew GTS Sleeve and GTS Screw are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction." This matches the implied intended use of the predicate devices.
2. Similar Technological Characteristics: The device should share similar design features, materials, and operational principles with the predicate device. This includes:	Met: - Multi-channeled, single construct: Both the GTS Sleeve/Screw and the Intrafix™ Tibial Sheath and Tapered Screw employ this design. - Central screw placement: Both designs allow for this. - Tapered screw for fixation: Both use a tapered screw to create final fixation. - Bioresorbable components: The GTS Tapered Screw is bioresorbable, similar to predicate devices (K032224 and K992396 BioRCT® Screws). - Similar Geometries and Range of Sizes: Implied to be similar to the predicate. - Single patient use & EO sterilized: Both share these characteristics.
3. Safety and Effectiveness: The device must be as safe and effective as the predicate device. This is supported by: - In vitro performance testing: To demonstrate functional equivalence and appropriate mechanical properties. - Material biocompatibility: To ensure the materials used are safe for implantation. - Sterilization validation: To confirm the device can be effectively sterilized without compromising safety or performance. - Clinical performance (implied): While not a separate clinical study, the substantial equivalence implies that if the predicate is safe and effective, and the new device is sufficiently similar, it also meets these criteria.	Met: "The in vitro performance testing, material biocompatibility and sterilization validation demonstrate the device is safe, effective for its intended use, and supports a decision of substantial equivalence." (Specific results of these tests are not detailed in this summary.)

Study Details from the Provided Text:

The provided text describes a 510(k) Premarket Notification process, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study to establish novel acceptance criteria and meet them.

A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" are implied by the requirements for substantial equivalence. "Reported device performance" is a summary statement of having met these criteria through various tests.
Sample size used for the test set and the data provenance:
- Not specified in the provided text. The text mentions "in vitro performance testing," "material biocompatibility," and "sterilization validation." These typically involve testing a specific number of device samples or material specimens according to relevant standards, but no specific sample sizes are given.
- Data Provenance: The document is dated March 1, 2004, from Smith & Nephew, Inc., Endoscopy Division, located in Andover, MA, USA. The testing would have been conducted to support this submission, likely within the manufacturer's R&D or quality assurance facilities, possibly in the USA. It would be considered prospective for the purpose of this submission, meaning the tests were performed to gather data for this specific regulatory filing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. Clinical expert consensus for ground truth is typically relevant for diagnostic devices or observational studies. This submission focuses on a mechanical fixation device and its equivalence to predicates through in vitro (bench) testing, material analysis, and sterilization.
Adjudication method for the test set:
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human assessment (e.g., image interpretation). This submission details in vitro testing.
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. This device is a mechanical bone fixation device, not an AI-assisted diagnostic or decision support tool, and the submission does not describe a clinical comparative effectiveness study involving "human readers" or "AI."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the in vitro performance testing, the "ground truth" would be established by engineering standards and specifications (e.g., ASTM or ISO standards for mechanical properties like pull-out strength, torque resistance, fatigue life, or material biocompatibility standards). The results of these tests are compared against pre-defined engineering requirements or directly against the predicate device's known performance characteristics (if publicly available or previously established).
The sample size for the training set:
- Not applicable. There is no "training set" in the context of this 510(k) submission for a mechanical device. Training sets are relevant for machine learning algorithms.
How the ground truth for the training set was established:
- Not applicable. See point 8.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the implied acceptance criteria (substantial equivalence) consists of bench testing (in vitro performance testing), material biocompatibility testing, and sterilization validation. The specific details of these tests (e.g., exact protocols, number of samples for each test, detailed results) are not provided in this 510(k) summary but would be present in the full 510(k) submission document. The summary broadly states that these tests demonstrate safety and effectiveness for its intended use, supporting the decision of substantial equivalence to the identified predicate devices (Intrafix™ Tibial Sheath and Tapered Screw, and Smith & Nephew BioRCT® Screws K032224 & K992396).

Summary

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K040542 pg. 1 of 2

AUG 1 9 2004

We are smith&nepher

Endoscopy Division Smith & Nephew, Inc 150 Minuteman Road Andover, MA 01810

1978-749-1371 F 978-149-1443 www.smith-nephew.com

SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

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

The Smith & Nephew GTS Sleeve and GTS Tapered Screw Date Prepared: 1 March 2004

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

B. Company Contact

Marion W. Gordon, RAC Regulatory Affairs Specialist Fax: 978-749-1443 Phone: 978-749-1371

C. Device Name

Trade Name:	The Smith & Nephew GTS Sleeve and GTS Tapered Screw
Common Name:	Fixation, bone, screw
Classification Name:	Smooth or metallic bone fixation fastenerper 21 CFR § 888.3040

D. Predicate Devices

The Smith & Nephew GTS Sleeve and GTS Tapered Screw are substantially equivalent to Intrafix™ Tibial Sheath and Intrafix™ Tibial Tapered Screw, manufactured by Innovasive Devices, Inc. (acquired by Johnson & Johnson, November 1999) and found substantially equivalent on 28 January 1999 under K983560. In addition, the proposed GTS Tapered Screw is substantially equivalent to Smith & Nephew, Inc. K032224 (SE 08/05/03) and K992396 (SE 01/12/00) BioRCT® Screws.

E. Description of Device

GTS Page 032 of 076

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pge 2/2

We are smith&nephow

SECTION IV cont.

F. Intended Use

The Smith & Nephew GTS Sleeve and GTS Screw are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

G. Comparison of Technological Characteristics

Comparison of Technological GTS Sleeve and GTS Tapered Screw and the I he proposed Shillth & Nephew OTB Bloove and Ore of Screw share the same indications for Intrallx ... Tiolal Sheath and mittallis - rapers - Both employ a multi channeled, single construct device (one channel for central screw placement) to manage, protect and construct device (one channel for ochara sthe ... The tapered screw creates the final fixation within a created tibial tunnel. The bioresorbable GTS Tapered Screw and nonwithin a created troial tunnol. The similar geometries and range of sizes. Each device is packaged as single patient use and EO sterilized.

H. Summary Performance Data

Suith & Nephew GTS Sleeve and GTS Tapered Screw utilize design features and Shifth & Nephow OFD breat are redicate device. The in vitro performance testing, material biocompatibility and sterilization validation demonstrate the device is safe, matorial of over intended, and supports a decision of substantial equivalence.

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2004

Ms. Debra Connors Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K040542

Trade/Device Name: GTS Sleeve and GTS Tapered Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 9, 2004 Received: June 10, 2004

Dear Ms. Connors:

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 for work in 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.

{3}------------------------------------------------

Page 2 - Ms. Debra Connors

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) 594-4639. 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 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 Wilkerson
for
Julie M. Witten, Ph.D., M.D.

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

K040542

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Smith & Nephew GTS Sleeve and GTS Tapered Screw are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

fo Mark A. Mellema
Division Sign Off

Division Sion ... Division of General, Restorative, and Neurological Devices

510(k) Number K040542

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

110 Over-The-Counter Use (Per 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __

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.