Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion 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.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

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

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Device Description

The Arthrex Corkscrew FT II Suture Anchor is a 5.5 x 16mm fully threaded (FT) nondegradable screw that is available configured with suture or with suture and needles.

AI/ML Overview

The provided text is a 510(k) Summary for the Arthrex Corkscrew FT II Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance data in the typical sense of a diagnostic or AI device.

Therefore, many of the requested sections about acceptance criteria, study data, ground truth, and expert evaluation are not applicable to this type of regulatory submission for a medical device like a suture anchor. This document does not describe the performance of the device in a way that generates numeric metrics like sensitivity or specificity. Instead, the "performance" is implicitly demonstrated through substantial equivalence to a device already deemed safe and effective.

Here's an attempt to answer the questions based on the available information, noting where sections are not applicable:

Acceptance Criteria and Device Performance for Arthrex Corkscrew FT II Suture Anchor

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

Acceptance Criteria (Implied)	Reported Device Performance
Material Equivalence: Materials of construction are effectively the same or have similar biocompatibility and mechanical properties as the predicate.	The device is a "fully threaded (FT) nondegradable screw," implying similar material properties to the predicate. No specific material acceptance criteria or test results (e.g., tensile strength, corrosion resistance) are explicitly stated in this summary, but these would have been part of the full 510(k) submission to demonstrate equivalence.
Design Equivalence: The functional design (e.g., screw type, method of suture attachment) is similar enough to the predicate.	The device is described as a "5.5 x 16mm fully threaded (FT) nondegradable screw" and "available configured with suture or with suture and needles," which implies a similar design and function to the predicate "Corkscrew Suture Anchor." Specific design parameters would have been compared in the full submission, but are not in this summary.
Intended Use Equivalence: The target anatomical locations and surgical indications are identical or highly similar to the predicate.	The intended uses listed (fixation of suture to bone in various anatomical regions like shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis for specific repairs) are directly compared and found to be "the same" as the predicate.
Performance Equivalence (Mechanical/Functional): The device performs its intended function (fixation of suture to bone) similarly to the predicate. This would typically involve mechanical testing (e.g., pull-out strength, fatigue).	The summary states, "Any differences between the Arthrex Corkscrew FT II Suture Anchor and the predicate Arthrex Corkscrew Suture Anchor are considered minor and do not raise questions concerning safety and effectiveness." This implies that any mechanical or functional performance tests conducted (which are not detailed in this summary) demonstrated comparable results to the predicate, satisfying the requirement for substantial equivalence.
Safety and Effectiveness Equivalence: The device is as safe and effective as the predicate.	"Based on the information submitted, Arthrex, Inc. has determined that the new Corkscrew FT II Suture Anchor is substantially equivalent to the currently marketed predicate device." This is the ultimate "performance" metric in a 510(k) summary, meaning it meets the FDA's threshold for safety and effectiveness compared to the predicate.

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 document describes a medical device (suture anchor) for surgical implantation, not a diagnostic device or AI algorithm that would have a "test set" in the context of clinical or algorithmic performance evaluation (e.g., images for diagnostic accuracy). The data provenance for mechanical testing (if part of the full submission) would typically be from laboratory testing rather than patient 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. As this is not a diagnostic or AI device, there is no "ground truth" to be established by experts in the sense of clinical interpretations or disease presence. The "ground truth" for a device like this is its physical and mechanical properties, and its safe and effective function in vivo, which is assessed through a combination of engineering tests, biocompatibility assessments, and clinical experience with similar predicate devices.

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

Not Applicable. There is no "adjudication method" described as this is not a diagnostic study requiring consensus on interpretations.

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 hardware medical device (suture anchor), not an AI-assisted diagnostic tool.

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

Not Applicable. This is a hardware medical device, not an algorithm.

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

Not Applicable, in the typical sense of a diagnostic test. For a surgical implant like this, "ground truth" for safety and effectiveness is established through:
- Biocompatibility testing: Ensuring the materials are safe for implantation.
- Mechanical testing: Demonstrating adequate strength, fatigue resistance, and pull-out strength in a lab setting (e.g., using synthetic bone models or cadaveric tissue).
- Clinical experience with predicate devices: Relying on the established safety and effectiveness of the legally marketed predicate device.
- Literature review: Supporting the intended use and performance with existing medical knowledge.
  The summary does not detail these specific "ground truths" but assumes they were addressed in the full 510(k) submission to support substantial equivalence.

8. The sample size for the training set

Not Applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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K050358

Page 1 of 2-

VIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENES

ARTHREX CORKSCREW SUTURE ANCHOR

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

510(K) CONTACT:

Ann Waterhouse, RAC Sr. Regulatory Affairs Specialist Telephone: (239) 643-5553 ext. 1179 FAX: (239) 598-5539

TRADE NAME:

Corkscrew FT II Suture Anchor

Fastener; Screw, Fixation, Bone; Suture

COMMON NAME: PRODUCT CODE /

CLASSIFICATION NAME

HWC/ 21 CFR 888.3040

Fastener, Fixation, Nondegradable, Soft Tissue Smooth or threaded metallic bone fixation fastener

GAT/21 CFR 8788.5000

Suture, Nonabsorbable Synthetic Polyethylene

PREDICATE DEVICE:

Corkscrew Suture Anchor: K003816 & K971723

DEVICE DESCRIPTION AND INTENDED USE:

The Arthrex Corkscrew FT II Suture Anchor is a 5.5 x 16mm fully threaded (FT) nondegradable screw that is available configured with suture or with suture and needles. The Arthrex Corkscrew FT II Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis. Specifically:

Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: 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.

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.

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K050358

Page 2 of 2

Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Hand/Wrist: Reconstruction, Radial Collateral Ligament Reconstruction.

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

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

SUBSTANTIAL EQUIVALENCE SUMMARY

The Arthrex Corkscrew FT II Suture Anchor is substantially equivalent to the predicate Arthrex Corkscrew Suture Anchor in which the basic features and intended uses are the same. Any differences between the Arthrex Corkscrew FT II Suture Anchor and the predicate Arthrex Corkscrew Suture Anchor are considered minor and do not raise questions conceming safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new Corkscrew FT II Suture Anchor is substantially equivalent to the currently marketed predicate device.

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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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Public Health Service

APR 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ann Waterhouse, RAC Senior Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1845

Re: K050358

Trade/Device Name: Arthrex Corkscrew FT Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBI, GAT Dated: March 15, 2005 Received: March 17, 2005

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 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 Erth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Ann Waterhouse

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ough maning of substantial equivalence of your device to a legally premation redicate device 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 If you desire specific acres at (240) 276-0120 . Also, please note the regulation entitled, Contact the Office of Conner to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Tom Allen

Miriam C. Provost, Ph.D. pr Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ___Koso358

Device Name: Arthrex Corkscrew FT Suture Anchor

Indications for Use:

The Arthrex Corkscrew FT Suture Anchor is intended for fixation of suture to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shouldor: - Notator - 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.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

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

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Prescription Use	X	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
AGE IF NEEDED) And The
The state of the state the may and comments of the commentation of the comments of the comments of the comments of the comments of the comments of the comments of the comment서울동문동문제출사무역사무부산부문제출장부르부동문콜로부르부르부동문출장업소동문출장부르부모텔출장마사지샵

Concurrence of CORH, Office Af Device Evaluation (ODE)

Page 1 of

Ko5o358

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.