The Arthrex FastThread Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; specifically,

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair, MPFL Repair/Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist

Device Description

The Arthrex FastThread Interference Screw is a cannulated, fully threaded, bioabsorbable interference screw, manufactured from PLDLA, Biphasic Calcium Phosphate and hydroxyapatite (HA). The screws measure 6-12 mm in diameter and 20-30 mm in length.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device, the Arthrex FastThread Interference Screw. It outlines the device's indications for use, its comparison to predicate devices, and the performance data submitted for its clearance.

However, the information provided does not contain details about acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods for an AI/ML-based medical device study.

Instead, this document describes the regulatory submission for a physical, implantable medical device (an interference screw) and its mechanical and biological performance data. The "Performance Data" section specifically states:

"Mechanical testing demonstrated that the pull-out strength of the proposed Arthrex FastThread Interference Screw met the acceptance criterion established by K201749 for MPFL repair/reconstruction."
"Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications."

This indicates that the acceptance criteria and study proving the device meets them are related to the physical properties and safety of the implantable screw, not to the performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding AI/ML device performance from this document. The questions posed in your prompt (e.g., "Number of experts used to establish the ground truth", "Adjudication method", "MRMC comparative effectiveness study", "Standalone performance", "Training set ground truth") are relevant to the evaluation of AI/ML software as a medical device, which is not what this document describes.

Summary

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November 18, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Arthrex Inc. Jessica L. Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108

Re: K202535

Trade/Device Name: Arthrex FastThread Interference Screw Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: October 22, 2020 Received: October 26, 2020

Dear Ms. Singelais:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202535

Device Name Arthrex FastThread Interference Screw

Indications for Use (Describe)

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared	October 22, 2020
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Jessica L. SingelaisRegulatory Affairs Specialist1-239-598-4302, ext. 73091Jessica.singelais@arthrex.com
Name of Device	Arthrex FastThread Interference Screw
Common Name	Fastener, Fixation, Biodegradable, Soft TissueScrew, fixation, bone
Product Code	MAI, HWC
Classification Name	888.3030 Single/multiple component metallic bone fixation appliances andaccessories888.3040 Smooth or threaded metallic bone fixation fastener
Regulatory Class	II
Predicate Device	K180662: Arthrex FastThread Interference Screw
Reference Device	K201749: Arthrex SwiveLock Suture AnchorK173240: Arthrex PushLock
Purpose of Submission	This Special 510(k) premarket notification is submitted to expand indications forthe Arthrex FastThread Interference Screw cleared under K180662 to includeMPFL Repair/Reconstruction.
Device Description	The Arthrex FastThread Interference Screw is a cannulated, fully threaded,bioabsorbable interference screw, manufactured from PLDLA, Biphasic CalciumPhosphate and hydroxyapatite (HA). The screws measure 6-12 mm in diameterand 20-30 mm in length.
ComparisonSummary ofTechnologicalCharacteristics andModificationsProposed	The proposed and predicate devices (K180662) have the same technologicalcharacteristics (device design, sterilization and biocompatibility). Therefore,sterilization and biocompatibility data can be leveraged from the previousclearance. The proposed device modification consists of the addition of the MPFLRepair/Reconstruction indication and an extended shelf life. The shelf-life hasbeen extended using the same methods and protocol reviewed and accepted byFDA in K173240.
Indications for Use	The Arthrex FastThread Interference Screw is substantially equivalent to thepredicate device in which the design features and intended uses are thesame. Any differences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness.The Arthrex FastThread Interference Screws are intended to be used for fixationof tissue, including ligament or tendon to bone, or a bone/tendon to bone.Interference fixation is appropriate for surgeries of the knee, shoulder, elbow,ankle, foot, and hand/wrist where the sizes offered are patient appropriate;specifically,Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift orCapsulolabral ReconstructionFoot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament
	Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendontransfers in the foot and ankle
	Knee : Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair,Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior ObliqueLigament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair,MPFL Repair/Reconstruction
	Elbow : Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction
	Hand/Wrist : Scapholunate Ligament Reconstruction, Ulnar Collateral LigamentReconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal jointarthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructionsand repairs, tendon transfer in the hand/wrist
Performance Data	Mechanical testing demonstrated that the pull-out strength of the proposedArthrex FastThread Interference Screw met the acceptance criterion establishedby K201749 for MPFL repair/reconstruction.
	Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications.
Conclusion	Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate device.

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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.