The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:

Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and,
Hallux Valgus reconstruction (correction) by providing for the reduction of 1st Metatarsal – 2nd metatarsal intermetatarsal angle.

The Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the thumb metacarpal by providing stabilization between the base of the first and second metacarpals when the trapezium has been excised due to osteoarthritis. The Mini TightRope and Mini TightRope FT are also indicated for use as adjuncts 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 Mini TightRope devices are designed in two basic configurations: two metal buttons and a pre-threaded FiberWire suture and; one metal button, one bioabsorbable suture anchor.

AI/ML Overview

The provided text describes the Arthrex Mini TightRope devices and their intended use, but it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically associated with AI/ML device evaluations.

Instead, this document is a 510(k) premarket notification for a medical device (Mini TightRope) seeking clearance for an expanded indication. The evaluation for this type of device relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than meeting quantitative performance metrics against a defined acceptance criterion through a study as would be seen for an AI/ML diagnostic or prognostic tool.

Therefore, many of the specific points requested (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are not applicable to this type of traditional medical device submission based on the provided text.

Based on the provided text, here's what can be extracted and inferred:

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

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance
Predicate Device Similarity: Basic design features and intended uses are the same as the predicate (Mini TightRope, K090107).	The Arthrex Mini TightRope family of devices is substantially equivalent to the predicate devices, in which the basic design features and intended uses are the same.
Mechanical Strength (Shear & Tensile): Adequate for the desired proposed indication of Hematoma Distraction Arthroplasty (HDA).	The submitted mechanical testing data demonstrates that the shear and tensile strength of the predicate devices are adequate for the desired proposed indication.
Clinical Efficacy (Literature Review): Supports the use for HDA.	The submitted clinical literature review demonstrates the same.
Safety and Effectiveness: No new questions concerning safety and effectiveness compared to the predicate device for the new indication.	The modifications to the indications for use of the predicate devices are considered minor and do not raise questions concerning safety and effectiveness.

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

Not Applicable. This submission is based on demonstrating substantial equivalence to a predicate device and mechanical testing, not a clinical study on a patient test set in the conventional sense for AI/ML. The "mechanical testing data" would refer to laboratory tests on the device itself.
Data Provenance: The document does not specify the origin of the mechanical testing data.

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):

Not Applicable. No ground truth establishment for a patient "test set" is described for this device as it's a mechanical device, not an AI/ML diagnostic.

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

Not Applicable. No human adjudication for a test set is described.

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:

Not Applicable. This is a mechanical surgical implant, not an AI/ML imaging or diagnostic device that assists human readers.

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

Not Applicable. This is a mechanical surgical implant, not an AI/ML algorithm.

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

The "ground truth" for this device's performance is established through mechanical testing data (shear and tensile strength) and clinical literature review to support its adequacy for providing stabilization as an "adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty."

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/ML device.

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

Not Applicable. There is no "training set" and associated ground truth establishment for this type of device.

Summary

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Date Summary Prepared	29 JANUARY 2014
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Nancy HoftRegulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71113Fax: 239/598.5508Email: nancy.hoft@arthrex.com
Trade Name	Mini TightRope
Common Name	Button / Anchor / Suture
Product Code,Classification Name, CFR	HTN – Single/multiple component metallic bone fixation appliances and accessories -888.3030
Predicate Device	Mini TightRope, K090107
Purpose of Submission	This traditional 510(k) premarket notification is submitted to introduce to the clearedArthrex Mini TightRope devices, K090107:• A second Carpal Metacarpal (CMC) joint indication of HematomaDistraction Arthroplasty (HDA).
Device Description	The Mini TightRope devices are designed in two basic configurations: two metalbuttons and a pre-threaded FiberWire suture and; one metal button, onebioabsorbable suture anchor.
Intended Use	The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracturerepair involving metaphyseal and periarticular small bone fragments where screws arenot indicated, and as adjuncts in external and intramedullary fixation systems involvingplates and rods, with fracture braces and casting.Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended toprovide fixation during the healing process following:1. Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament(DRUL) disruptions;2. Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separationsdue to a Lisfranc injury (Midfoot Reconstruction); and,3. Hallux Valgus reconstruction (correction) by providing for the reduction of 1stMetatarsal – 2nd metatarsal intermetatarsal angle.The Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation ofbone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distributionbridges, or for distributing suture tension over areas of ligament or tendon repair.Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are indicated forCarpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of thethumb metacarpal by providing stabilization between the base of the first and secondmetacarpals when the trapezium has been excised due to osteoarthritis. The MiniTightRope and Mini TightRope FT are also indicated for use as adjuncts in thesuspension of the thumb metacarpal during the healing process of hematomadistraction arthroplasty by providing stabilization at the base of the first and secondmetacarpal when the trapezium has been excised due to osteoarthritis.
Substantial EquivalenceSummary	The Arthrex Mini TightRope family of devices is substantially equivalent to thepredicate devices, in which the basic design features and intended uses are the same.

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predicates are considered minor and do not raise questions concerning safety and effectiveness.

The Mini-TightRope family of devices, when used as adjuncts in the suspension of the thumb metacarpal during the healing process, provides adequate stabilization for hematoma distraction arthroplasty (HDA) at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis. The submitted mechanical testing data demonstrates that the shear and tensile strength of the predicate devices are adequate for the desired proposed indication. The submitted clinical literature review demonstrates the same.

Based on the proposed indication for use, technological characteristics, and the summary of data submitted, Arthrex, inc., has determined that the Arthrex Mini TightRope family of devices is substantially equivalent to the currently marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract human figure.

Public Health Service

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

January 30, 2014

Arthrex, Incorporated Ms. Nancy Hoft Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108

Re: K133275

Trade/Device Name: Mini TightRopes 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: November 6, 2013 Received: November 12, 2013

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

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Page 2 - Ms. Nancy Hoft

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 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" (21 CFR 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. Wigqins

for

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

Enclosure

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TRADITIONAL 510k: Arthrex Min1 TightRopes, 18 OCT 2013

K133275

2.4 INDICATIONS FOR USE

Indications for Use

510(k) Number (if known):

Device Name: Mini TightRopes

Indications For Use:

Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:

Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) 1) disruptions;
1. Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and,
Hallux Valgus reconstruction (correction) by providing for the reduction of 1st 3) Metatarsal - 2nd metatarsal intermetatarsal angle.

The Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation of bone-tobone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the thumb metacarpal by providing stabilization between the base of the first and second metacarpals when the trapezium has been excised due to osteoarthritis. The Mini TightRope and Mini Tight Rope FT are also indicated for use as adjuncts 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.

Prescription Use _ AND/OR Over-The-Counter Use _ (Per 21 CFR 801 Subpart D) (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)

PAGE 1 of 1

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

Page 13 of 242

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.