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

Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
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

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Arthrex Interference Screw." This type of document is for clearance of a device based on substantial equivalence to a predicate device, not for a de novo FDA approval which would typically involve clinical studies proving acceptance criteria for performance.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving a device meets them for an AI/ML or imaging-based medical device.

Here's why and what the document does provide:

Device Type: The "Arthrex Interference Screw" is a physical orthopedic implant (a fixation device for ligaments/tendons to bone), not an AI/ML, software, or imaging-based device.
Regulatory Pathway: A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, materials, and intended use, and may include bench testing, but typically does not require new clinical studies to establish performance acceptance criteria against human readers or a set ground truth in the way an AI/ML product would.
Lack of Specific Information: Consequently, the document does not mention:
- Acceptance criteria for an algorithm's performance (e.g., sensitivity, specificity, accuracy).
- Sample sizes for test sets or training sets.
- Data provenance (country, retrospective/prospective) for a study.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes, expert consensus) for algorithm validation.
- How ground truth was established for a training set.

What the document does describe is:

Intended Use: Fixation of tissue (ligament/tendon to bone and bone tendon bone) in various anatomical locations (knee, shoulder, elbow, ankle, foot, hand/wrist) for specific repairs and reconstructions.
Device Materials: PEEK, Titanium, or Bioabsorbable Polymer.
Predicate Device: Arthrex Interference Screw (K052607).
Substantial Equivalence Claim: The new device is substantially equivalent to the predicate, with any differences considered minor and not raising safety/effectiveness concerns.

In summary, to answer the prompt directly based on the provided text: The document does not describe acceptance criteria for an AI/ML device or a study proving such criteria are met.

Summary

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NOV 2 9 2006

VIII. 510(k) Summary of Safety and Effectiveness

Arthrex Interference Screw

Manufacturer / Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, Florida 34108-1945
510(k) Contact:	Ann Waterhouse, RACRegulatory Affairs Project ManagerTelephone: (239) 643-5553 ext. 1179FAX: (239) 598-5508
Trade Name:	Arthrex Interference Screw
Common Name:	Fastener, Fixation, bone, degradable andnondegradable
Product Code /	HWC, 21 CFR 888.3040MAI, 21 CFR 888.3030MBI, 21 CFR 888.3040
Classification Name:	Fixation, Fastener, bone
Predicate Device:	Arthrex Interference Screw, K052607

Device Description and Intended Use:

Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle

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

Substantial Equivalence:

The Arthrex Interference Screw is substantially equivalent to the predicate Arthrex Interference Screw in which the basic features and intended uses are the Any differences between the Arthrex Interference Screw and the same. predicate are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the PEEK, PLLA, and Titanium Interference Screw are substantially equivalent to the currently marketed predicate device.

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Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure.

NOV 2 9 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrex, Inc. % Ann Waterhouse, RAC Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K062466

Trade/Device Name: Interference Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Codes: MAI, MBI, HWC Dated: November 6, 2006 Received: November 8, 2006

Dear Ms. Waterhouse:

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

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Page 2 - Ann Waterhouse, RAC

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. 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" (21CFR 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 vours.

Вашава Внешир

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 Form ==============================================================================================================================================================================

KOG 2466 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Arthrex Interference Screw

Indications for Use:

Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Radial Collateral Ligament Reconstruction, Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist

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

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

============================================================================================================================================================================== Concurrence of CDRH, Office of Device Evaluation (Open vision

Division of General, Restoracya. and Neurological Devices

510(k) Number / < 0 (24) 246 (s

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.