The SLIC Screw Repair System is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.

Device Description

The SLIC Screw Repair System consists of a headless, cannulated two-piece screw assembly. The two-piece design incorporates the use of distal and proximal screw components to anatomically reduce two bones. The purpose of this Special 510(k) is to modify the material, interconnection geometry and available sizes of the SLIC Screw. All components are made of 22-13-5 stainless steel conforming to ASTM F1314. These modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

AI/ML Overview

The provided text describes a medical device called the "SLIC Screw Repair System" and its Special 510(k) submission to the FDA. The submission focuses on modifications to the device's material, interconnection geometry, and available sizes.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Insertion Testing	To ensure proper functionality during surgical insertion.	Results demonstrate that acceptance criteria were met.
Pull-Apart Testing	To evaluate the strength and integrity of the screw assembly under tensile load.	Results demonstrate that acceptance criteria were met.
Pull-Out Strength Testing	To assess the force required to remove the screw from bone.	Results demonstrate that acceptance criteria were met.

Note: The specific numerical acceptance criteria are not provided in the document. The statement "The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met" indicates that such criteria exist and were satisfied.

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

The document states that "Preclinical Testing" was performed. However, it does not provide details on the sample size used for the insertion testing, pull-apart testing, or pull-out strength testing.

The data provenance is preclinical testing directly on the device components, not human or animal data. It is therefore not applicable to country of origin or retrospective/prospective classification in the typical sense of clinical studies.

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

This information is not applicable as the testing described is preclinical mechanical testing of hardware, not interpretation of medical images or clinical outcomes that would require expert ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable as the testing described is preclinical mechanical testing performed by technical personnel, not clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable. The device described is a surgical implant (SLIC Screw Repair System), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. As mentioned above, this is a surgical implant, not an algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The "ground truth" for the preclinical tests would be the engineering specifications and performance thresholds defined in the "Design Control Activities Summary." The tests measure objective mechanical properties directly, not subjective interpretations or clinical outcomes.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical medical device, 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 information is not applicable for the same reason as point 8.

Summary

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KIII 608 (112)

AUG 2 9 2011

5. 510(k) Summary

Device Trade Name:	SLIC Screw Repair System
Manufacturer:	Acumed, LLC5885 NW Cornelius Pass RoadHillsboro, OR 97124
Contact:	Ms. Lino TsaiRegulatory SpecialistPhone: 503.627.9957
Prepared by:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	June 8, 2011
Classification:	21 CFR 888.3040, Smooth or threaded metallic bonefixation fastener
Class:	II
Product Code:	HWC

Indications For Use:

Device Description:

The purpose of this Special 510(k) is to modify the material, interconnection geometry and available sizes of the SLIC Screw. All components are made of 22-13-5 stainless steel conforming to ASTM F1314. These modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

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Predicate Device:

The modified SLIC Screw Repair System is substantially equivalent to the predicate ARC Surgical Bone Reduction System (K063244) with respect to indications, design, function, and materials.

Preclinical Testing:

The new components were subjected to insertion testing, pull-apart testing and pull-out strength testing. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.

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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 stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Acumed, LLC % Ms Lino Tsai Regulatory Specialist 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124

AUG 2 9 2011

Re: K111608

Trade/Device Name: SLIC Screw Repair System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bond fixation fastener Regulatory Class: II Product Code: HWC Dated: August 5, 2011 Received: August 8, 2011

Dear Ms. Tsai:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Lino Tsai

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson Director

Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use 4.

510(k) Number (if known): _

Device Name: SLIC Screw Repair System

Prescription Use ﮯ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M.Melleem

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111608

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.