The Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device is intended as an adjunct in fracture repair providing fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions or fixation of ankle syndesmosis due to anterior inferior tibiofibular ligament and/or posterior inferior tibiofibular ligament disruptions.

Device Description

The Smith & Nephew Ultraslide Device allows for endoscopic fixation following a syndesmotic trauma as Coracoclavicular Separations or Ankle Syndesmotic Disruptions. The device consists of three components; two machined titanium ENDOBUTTON fixation devices on a continuous Polyester suture loop. It is prethreaded with a traction suture that is used for positioning of the fixation button. Although non-absorbable, the Ultraslide device does not require removal,

AI/ML Overview

Here's an analysis of the provided text regarding the Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence in design, indications, and fundamental scientific technology to predicate devices.	"The Smith & Nephew Ultraslide Device is substantially equivalent in design and function to the currently marketed Arthrex Tightrope™."
No statistically significant differences in cyclical displacement values compared to predicate devices.	"Statistical comparison of the test data of the cyclical displacement values... demonstrates that there are no statistically significant differences between the Smith & Nephew Ultraslide Device and the predicate devices."
No statistically significant differences in tensile strength compared to predicate devices.	"...tensile strength demonstrates that there are no statistically significant differences between the Smith & Nephew Ultraslide Device and the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample size used for the test set in terms of the number of devices or experimental replicates. It only refers to "test data."

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for mechanical medical devices, it is highly likely that the "test data" refers to prospective in-vitro mechanical testing conducted under controlled laboratory conditions, rather than human subject data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable to this type of submission. The "ground truth" for the performance of a mechanical device like this is established through objective physical measurements (e.g., tensile strength, displacement) in a laboratory setting, not through expert consensus or interpretation of clinical images.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, not in basic mechanical performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant to diagnostic imaging devices or algorithms where human readers interpret results, and the AI's impact on their performance is being evaluated. The Ultraslide device is a surgical implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was done, but it was a standalone device performance study (mechanical testing) rather than an algorithm-only standalone study. The performance of the Ultraslide device was evaluated independently, and then statistically compared to predicate devices. There is no "algorithm" in this context as it's a physical device.

7. Type of Ground Truth Used

The ground truth used was objective physical measurements (e.g., cyclical displacement values, tensile strength) obtained through standardized mechanical testing protocols in a laboratory setting. These measurements directly reflect the inherent physical properties and performance of the device.

8. Sample Size for the Training Set

This information is not applicable. The Ultraslide Device is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above. There is no training set for a mechanical medical device.

Summary

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Endoscopy Sinth ? Hernew by 150 Minon nom Band Arthoven, MA. (1) 810

SECTION IV

2000 000 078 140 140 1118 www.tmth.nephose.com

K082095-R
We are

OCT 2 1 2002

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.

Traditional 510(k) Submission of Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device

Date Prepared: July 22, 2008

A. Submitter's Name:

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

B. Company Contact

Kathy Reddig Regulatory Affairs Specialist II 978-749-1321 (Phone) 978-749-1443 (Fax) kathy.reddig@smith-nephew.com

C. Device Name

Trade Name:	Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device
Common Name:	Non-Absorbable Suture /Button Retention Device
Classification Name:	Single / multiple component metallic bone fixation appliances and accessories

D. Predicate Devices

The Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device is substantially equivalent in design, indications and fundamental scientific technology to the following legally marketed devices in commercial distribution: Arthrex Tightrope™ Acromioclavicular (AC) Device (cleared via K052776) and the Arthrex Tightrope™ Syndesmosis Device (cleared via K043248).

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E. Description of Device

F. Intended Use

The Smith & Nephew Ultraslide Device is intended as an adjunct in fracture repair providing fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions or fixation of ankle syndesmosis due to anterior inferior tibiofibular ligament and/or posterior inferior tibiofibular ligament disruptions.

G. Comparison of Technological Characteristics

The Smith & Nephew Ultraslide Device is substantially equivalent in design and function to the currently marketed Arthrex Tightrope™. The proposed and the predicate devices both have the same indications and the same fundamental scientific technology.

H. Summary Performance Data

Statistical comparison of the test data of the cyclical displacement values and tensile strength demonstrates that there are no statistically significant differences between the Smith & Nephew Ultraslide Device and the predicate devices.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's role in public health and welfare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. Endoscopy Division % Ms. Kathy Reddig Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810

OCT 2 1 2008

Re: K082095

Trade/Device Name: Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTN Dated: July 22, 2008 Received: July 24, 2008

Dear Ms. Reddig:

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

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Page 2 - Ms. Kathy Reddig

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Miller

Mark N. Melkerson 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):

K08 2095

Device Name: Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device

Indications For Use:

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

Over-The-Counter Use No

er 21 CFR 801 Subpart D)

(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)
Mark A. Millerson

(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of Neurological Devices

510(k) Number

Page 18 of 58

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.