The Arthrex CMC Mini TightRope, when used for fixation of bone-to-bone or soft-tissue-tobone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex CMC Mini TightRope is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

Device Description

The Arthrex CMC Mini TightRope consists of two oblong stainless steel buttons and a single strand of #2 FiberWire.

AI/ML Overview

The provided FDA 510(k) summary is for the Arthrex CMC Mini TightRope, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a comprehensive clinical study in the way a diagnostic AI device would.

Therefore, many of the requested categories related to AI device performance evaluation (such as test set sample size, expert ground truth, MRMC studies, training set details) are not applicable to this document or this type of medical device clearance.

However, I can extract the relevant information from the provided text as it pertains to the device's substantial equivalence.

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

The concept of "acceptance criteria" and "reported device performance" in the context of this 510(k) submission relates to demonstrating substantial equivalence to a predicate device, rather than meeting specific quantifiable performance metrics as one might see for a diagnostic tool. The acceptance is that the device is substantially equivalent to the predicate.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as stated in submission)
Intended Use: Device performs as intended for bone-to-bone or soft tissue-to-bone fixation, specifically for CMC joint arthroplasty as an adjunct in suspension of the thumb metacarpal during healing of hematoma distraction arthroplasty by providing stabilization when trapezium is excised due to osteoarthritis.	The Arthrex CMC Mini TightRope is substantially equivalent to the Arthrex Implant System, Mini TightRope (K133275). It performs the same intended use.
Technological Characteristics: Similar materials, design, and operating principles to the predicate.	Device consists of two oblong stainless steel buttons and a single strand of #2 FiberWire, similar to the predicate. Differences are considered minor and do not raise questions concerning safety and effectiveness.
Safety and Effectiveness: Does not raise new questions of safety and effectiveness compared to the predicate.	"Any differences between the CMC Mini TightRope and this predicate are considered minor and do not raise questions concerning safety and effectiveness."

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This is a 510(k) for a medical implant, not a diagnostic device evaluated with a test set of data. The "test" for this device is based on demonstrating substantial equivalence through comparison of design, materials, and intended use with a predicate device, often supported by bench testing (though not detailed here) rather than human subject data sets.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts/Qualifications: Not applicable. This submission does not involve clinical data requiring expert review for ground truth establishment.

4. Adjudication method for the test set

Adjudication Method: Not applicable. There is no test set or adjudication process described in this 510(k) summary.

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

MRMC Study/Effect Size: Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool.

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

Standalone Performance: Not applicable. This is a medical implant, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: Not applicable. This submission relies on demonstrating substantial equivalence to a predicate device, not on diagnostic accuracy against a ground truth.

8. The sample size for the training set

Sample Size: Not applicable. There is no training set for a medical implant in this context.

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

Ground Truth Establishment: Not applicable.

Summary

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Arthrex Special. 510(K): ARTHREX CMC MINI TIGHTROPE

MAR 1 0 2014

Date Summary Prepared	06 FEBRUARY 2014
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Nancy HoftRegulatory Affairs SpecialistArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643-5553, ext.71113Fax: 239/598-5508Email: Nancy.Hoft@arthrex.com
Trade Name	CMC Mini TightRope
Common Name	Button / Anchor / Suture
Product Code,Classification Name, CFR	HTN - Single/multiple component metallic bone fixation appliances andaccessories -888.3030
Predicate Device	Mini TightRope, K133275
Purpose of Submission	This special 510(k) premarket notification is submitted to obtain clearance for theCMC Mini TightRope line extension.
Device Description	The Arthrex CMC Mini TightRope consists of two oblong stainless steel buttonsand a single strand of #2 FiberWire.
Intended Use	The Arthrex CMC Mini TightRope, when used for fixation of bone-to-bone or softtissue-to-bone, is intended as a fixation post, distribution bridge, or fordistributing suture tension over areas of ligament or tendon repair. Specifically,the Arthrex CMC Mini TightRope is indicated for Carpal Metacarpal (CMC) jointarthroplasty as an adjunct in the suspension of the thumb metacarpal during thehealing process of hematoma distraction arthroplasty by providing stabilization atthe base of the first and second metacarpal when the trapezium has been exciseddue to osteoarthritis.
SubstantialEquivalence Summary	The Arthrex CMC Mini TightRope is substantially equivalent to the ArthrexImplant System, Mini TightRope. Any differences between the CMC MiniTightRope and this predicate are considered minor and do not raise questionsconcerning safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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March 10, 2014

Arthrex, Inc. Ms. Nancy Hoft Regulatory Affairs Specialist 1370 Creekside Blvd. Naples, Florida 34108-1945

Re: K140328

Trade/Device Name: CMC Mini TightRope Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: February 6, 2014 Received: February 10, 2014

Dear Ms. Hoft:

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 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

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Page 2 - Ms. Nancy Hoft

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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.

Sincerely yours,

Lori A. Wiggins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Arthrex SPECIAL 510(K): ARTHREX CMC MINI TIGHTROPE

2.5 INDICATIONS FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K140328

Device Name

CMC Mini TightRope

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Ø Prescription Use (Part 21 CFR 801 Subpart D)

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

Please do not write below this line - continue on a separate page if needed.

国际游戏 | again | 亚游官网 | 亚洲官网 | 亚 FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Casey Li Hanley P. niof Orthopedic Devices Divisio

FORM FDA 3881 (9/13)

on 2 1013 64 147

PAGE 10 OF 34

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.