Shoulder:
Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis

Foot/Ankle:
Hallux Valgus ,Lateral stabilization, Medial stabilization, Achilles Tendon repair/recon, Midfoot reconstruction, Metatarsal Ligament/ tendon repair, Bunionectomy, Flexor Hullucis Longus repair, Tendon Transfers.

Elbow/Hand/Wrist:
Biceps Tendon Reattachment,Ulnar or Radial Collateral Ligament Recon, Lateral Epicondylitis Repair, Scapholunate Ligament Recon, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Recon / Repair

Knee:
Medial or Lateral Collateral ligament, Posterior oblique ligament, Vastus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair

Device Description

The Smith & Nephew PEEK Interference Screws, consisting of non-absorbable PEEK material, are interference screws for use in fixation of ligament, tendon or soft tissue grafts to bone in shoulder, elbow, knee, foot/ankle and hand/wrist procedures. The screws are cannulated.

AI/ML Overview

The provided text describes a 510(k) summary for the Smith & Nephew PEEK Interference Screws. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and proving performance against them in the way modern AI/ML device submissions do.

Here's a breakdown of why many of your requested points cannot be answered from this extract, and what information can be extracted:

This is not an AI/ML device. The device described is a physical medical implant (interference screws made of PEEK material). Therefore, concepts like "test set," "training set," "ground truth experts," "MRMC studies," and "standalone algorithm performance" are not applicable in the context of this submission.
Performance is generally shown through comparison to predicate devices. For traditional medical devices like this, the "acceptance criteria" are often implicitly met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "study" is a comparison study, not a performance study against predefined metrics.

Despite these limitations, I will extract what is relevant and indicate where information is not present or applicable.

Acceptance Criteria and Device Performance for Smith & Nephew PEEK Interference Screws

As this submission is for a physical medical device (interference screws) and not an AI/ML-based device, the concept of "acceptance criteria" in the AI/ML context (e.g., sensitivity, specificity, AUC) and associated studies (e.g., MRMC, standalone algorithm performance) are not applicable. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness through performance testing.

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Summary Performance Data)
Intended Use: Device performs the same function as predicates.	The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone, matching the intended use of predicate devices.
Technological Characteristics: Similar materials, design, and function as predicates.	Composed of non-absorbable PEEK material; cannulated screws for fixation of ligament/tendon/soft tissue grafts to bone in various joints. Similar to predicate devices.
Safety & Effectiveness: Device is as safe and effective as predicates.	Performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew PEEK Interference Screws are substantially equivalent to the Smith & Nephew Bioraptor 2.3PK and the Arthrex Interference Screw.

2. Sample size used for the test set and the data provenance:

Not applicable / Not specified for "test set" in an AI/ML sense. The document refers to "performance testing" but does not detail the sample sizes for these tests (e.g., number of screws tested, type of mechanical tests conducted).
Data Provenance: Not specified in terms of country of origin or retrospective/prospective for this type of performance testing. Such details are typically found in more comprehensive test reports, not the 510(k) summary itself.

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. "Ground truth" in the AI/ML sense (e.g., expert consensus on image interpretation) is not relevant for a physical medical device. Performance testing for this device would involve engineering and mechanical tests (e.g., pull-out strength, insertion torque), not expert interpretation.

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

Not applicable. Adjudication methods are specific to interpretative tasks, typically in AI/ML or clinical trial settings where agreement among experts is crucial for establishing ground truth or evaluating outcomes. This device's testing would not involve such a process.

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. MRMC studies are exclusively for evaluating diagnostic or screening systems where human readers interpret medical cases, often with and without AI assistance. This device is a surgical implant.

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

Not applicable. This question pertains to the performance of an AI algorithm operating independently of human input. The Smith & Nephew PEEK Interference Screws are a physical product, not an algorithm.

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

Not applicable in the AI/ML sense. For this device, "ground truth" would be established by validated engineering standards, biomechanical testing protocols, and mechanical measurements (e.g., force, torque, displacement) to assess properties like insertion force, pull-out strength, and resistance to fracture or bending. These are objective measurements, not expert consensus on an interpretation.

8. The sample size for the training set:

Not applicable. There is no "training set" for a physical device like this. Training sets are used in machine learning to teach an algorithm.

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

Not applicable. As there is no training set, there is no ground truth to be established for it.

Summary

{0}------------------------------------------------

Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810

978 749 1000 978 749 1599 Fax ww.smilh-nephew.com

We are smith&nephew

JAN 3 0 2009

SECTION IV

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Smith & Nephew PEEK Interference Screws

Date Prepared: 10/31/2008

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover, MA 01810

B. Company Contact

Kathy Reddig, RAC Regulatory Affairs Specialist II 978-749-1321 Phone 978-749-1443 Fax

C. Device Name

Trade Name:	Smith & Nephew PEEK Interference Screws
Common Name:	Fastener, Fixation, Non-degradable, Soft tissue
Classification Name:	Smooth or threaded metallic bone fixation fastener

D. Predicate Devices

The Smith & Nephew PEEK Interference Screws are substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew Bioraptor 2.3PK (K071586) and Arthrex Interference Screw (K062466)

{1}------------------------------------------------

K083226(2g2)

E. Description of Device

Intended Use

The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following:

Shoulder:

Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis

Foot/Ankle:

Hallux Valgus ,Lateral stabilization, Medial stabilization, Achilles Tendon repair/recon, Midfoot reconstruction, Metatarsal Ligament/ tendon repair, Bunionectomy, Flexor Hullucis Longus repair, Tendon Transfers.

Elbow/Hand/Wrist:

Biceps Tendon Reattachment,Ulnar or Radial Collateral Ligament Recon, Lateral Epicondylitis Repair, Scapholunate Ligament Recon, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Recon / Repair

Knee:

Medial or Lateral Collateral ligament, Posterior oblique ligament, Vastus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair

Comparison of Technological Characteristic F.

The Smith & Nephew PEEK Interference Screws are substantially equivalent in intended use, technological characteristics, and are as safe and as effective as their currently marketed predicate devices, the Smith & Nephew Bioraptor 2.3PK (K071586) and the Arthrex Interference Screw (K062466)

G. Summary Performance Data

The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew PEEK Interference Screws are substantially equivalent to the Smith & Nephew Bioraptor 2.3PK and the Arthrex Interference Screw

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc., Endoscopy Division % Ms. Kathy Reddig, RAC 150 Minuteman Road Andover, Massachusetts 01810

JAN 30 2009

Re: K083226

Trade/Device Name: Smith & Nephew PEEK Interference Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, HWC Dated: October 31, 2008 Received: November 3, 2008

Dear Ms. Reddig:

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. Iisting 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. Kathy Reddig, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041. or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millerson

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):

K083226

Device Name:

Smith & Nephew PEEK Interference Screws

The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following:

Shoulder:

Foot/Ankle:

Elbow/Hand/Wrist:

Knee:

Prescription Use x

AND/OR

(Per 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

Page 18 of 95

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices

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.