The Mini TightRope™ Repair Kit is interided as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Mini TightRope™ Repair Kit is intended to provide fixation during the healing process following:

Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
Tarasometatarsal (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.

Device Description

The Mini TightRope™ Repair Kit is designed as two differently sized metal buttons and FiberWire™ suture. The buttons are pre-threaded with FiberWire suture, looped twice through the buttoriholes. A pull-through FiberWire suture is looped through one button.

AI/ML Overview

Acceptance Criteria and Study for Mini TightRope™ Repair Kit

The provided document (K061925) is a 510(k) summary for a medical device called the Mini TightRope™ Repair Kit. It outlines the intended use and establishes substantial equivalence to predicate devices, rather than performing a de novo study with specific performance acceptance criteria and a detailed study validating those criteria.

Therefore, the typical structure for a study demonstrating acceptance criteria for device performance, especially in the context of AI/software or diagnostic devices, is not present in this document. This K-number filing is for a physical orthopedic implant/fixation device, and substantial equivalence is shown by demonstrating similar features, intended use, and safety/effectiveness profile to already approved devices.

However, I can extract the implied 'acceptance criteria' in the context of a 510(k) submission, which is primarily demonstrating substantial equivalence to predicate devices. The "study" in this case refers to the arguments and justifications made within the 510(k) submission itself to support this claim.

Implied Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence)

Acceptance Criteria (Implied by 510(k) Process)	Reported Device Performance (as presented in K061925)
Similar Intended Use	The Mini TightRope™ Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specific Indications: 1. Syndesmotic trauma (e.g., DRUL disruptions) 2. Tarsometatarsal (TMT) injury (e.g., Lisfranc injury) 3. Hallux Valgus reconstruction (reduction of 1st-2nd metatarsal intermetatarsal angle).
Similar Technological Characteristics/Design	The device consists of two differently sized metal buttons and FiberWire™ suture. The buttons are pre-threaded with FiberWire suture, looped twice through the buttonholes. A pull-through FiberWire suture is looped through one button.
Similar Materials	Metal buttons and FiberWire™ suture (implied to be similar or equivalent to predicate device materials in terms of biocompatibility and mechanical properties, though not explicitly detailed in this summary).
Similar Principles of Operation	Provides fixation during the healing process. Operates on the principle of a "button/suture" system for bone fixation.
No New Questions of Safety & Effectiveness	Arthrex states: "Any design differences between the Arthrex Mini TightRope™ Repair Kit when compared to predicate devices... are considered minor and do not raise any questions concerning safety and effectiveness. Any differences have been found to have no apparent effect on the performance, function, or intended use of the device."

Study Details (as inferred from a 510(k) submission focused on substantial equivalence):

Given the nature of a 510(k) for a physical implant, the concept of a "test set," "ground truth," "MRMC," or "standalone algorithm performance" as typically applied to AI/software or diagnostic devices is not applicable here. The "study" is the comparison made to predicate devices.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the traditional sense for this type of device submission. There isn't an "image dataset" or "patient cohort" test set for algorithm validation. The "test" is a comparison to established predicate devices.
- Data Provenance: The "data" here refers to the known performance, safety, and regulatory history of the predicate devices:
  - K041189: TRIM-IT Family (Arthrex, Inc.)
  - K052776: TightRope AC Device (Arthrex, Inc.)
  - K043248: TightRope Syndesmosis Device (Arthrex, Inc.)
    These are existing, legally marketed devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of AI/diagnostic devices, refers to a definitive diagnosis or outcome. For this mechanical device, "ground truth" is established through engineering principles, mechanical testing (often referenced in full 510(k) submissions, but not detailed here), and the clinical history of the predicate devices. Experts involved would be product engineers, regulatory specialists, and potentially clinical consultants, but not in the context of creating a labeled test set.
Adjudication method for the test set:
- Not applicable. There is no ambiguous "test set result" requiring adjudication. The comparison is based on objective device characteristics and intended uses.
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 physical orthopedic fixation device, not an AI or diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical orthopedic fixation device, not an algorithm.
The type of ground truth used:
- The "ground truth" is implicitly the established safety and effectiveness of the predicate devices based on their prior regulatory clearance, clinical use, and documented performance (e.g., mechanical strength, biocompatibility, historical clinical outcomes).
The sample size for the training set:
- Not applicable. There is no computational "training set" for an algorithm.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K061925 page
1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Mini TightRope™ Repair Kit

0C1 3 1 2006

NAME OF SPONSOR:

Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945

510(K) CONTACT:

Sally Foust, RAC Regulatory Affairs Project Manager Telephone: (239) 643-5553 ext. 1251 FAX: (239) 598-5539

TRADE NAME:

Mini TightRope™ Repair Kit

COMMON NAME:

Button/Suture

DEVICE PRODUCT CODE/CLASSIFICATION:

HTN: Single/multiple component metallic bone fixation appliances and accessories: 21 CFR 888.3030

PREDICATE DEVICES

K041189: TRIM-IT Family (Arthrex, Inc.) K052776: TightRope AC Device (Arthrex, Inc.) K043248: TightRope Syndesmosis Device (Arthrex, Inc.)

DEVICE DESCRIPTION AND INTENDED USE

The Mini TightRope™ Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

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page 2 of 2

Specifically, the Arthrex Mini TightRope Repair Kit is intended to provide fixation during the healing process following:

1. Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
1. Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
1. Hallux Valgus reconstruction (correction) by providing for the reduction of 155 metatarsal - 200 metatarsal intermetatarsal angle.

SUBSTANTIALLY EQUIVALENCE

Arthrex has determined that the Mini TightRope™ Repair Kit is substantially equivalent to the predicate devices where basic features and intended uses are the same. Any design differences between the Arthrex Mini TightRope™ Repair Kit when compared to predicate devices used in the standard medical practice for the treatment of DRUL disruptions in syndesmotic trauma, TMT (Lisfranc) injuries, and reduction for the 1st metatarsal - 2nd metatarsal intermetatarsal angle following Hallux Valgus reconstruction (correction) are considered minor and do not raise any questions concerning safety and effectiveness. Any differences have been found to have no apparent effect on the performance, function, or intended use of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrex, Inc. % Ms. Sally Foust, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108

0C7 3 1 2006

Re: K061925

Trade/Device Name: Mini TightRope™ Repair Kit 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: September 27, 2006 Received: September 28, 2006

Dear Ms. Foust:

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 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.

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Page 2 - Ms. Sally Foust, RAC

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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

for Pehns
Mark N. Malkerson

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):

K061925

Device Name Mini TightRope™ Repair Kit

Indications for Use:

Specifically, the Arthrex Mini TightRope™ Repair Kit is intended to provide fixation during the healing process following:

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

Prescription Use _X
(Per 21 CFR 801 Subpart D)	A

AND/C)R 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)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

Ko 61925

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.