Shoulder:
Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis

Foot/Ankle:
Hallux valgus repairs repairs/reconstructions Medial or lateral instability Achilles tendon repairs/reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquious advancement Illiotibial band tenodesis.

Elbow:
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Metatarsal ligament/tendon repairs/reconstruction Midfoot reconstructions

Device Description

The TWINFIX Ultra PK is a suture anchor manufactured from PEEK (polyetheretherketone) and is offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The screw-in anchor is preloaded with ultra high molecular weight polyethylene suture preassembled onto a stainless steel inserter.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Smith & Nephew TWINFIX Ultra PK Suture Anchor." It focuses on establishing substantial equivalence to a predicate device, not on demonstrating device performance against specific acceptance criteria through a clinical study in the same way an AI/ML device would. Therefore, most of the requested information for an AI/ML device study is not applicable.

Here's an analysis based on the provided text, highlighting what is and isn't available for a medical device clearance:

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

For a traditional medical device 510(k), acceptance criteria are typically met through bench testing (mechanical, material, and sterilization validation) and comparison of technological characteristics to a legally marketed predicate device. The goal is to show the device is as safe and effective as the predicate, not necessarily to meet pre-defined performance thresholds against a "ground truth" as in an AI study.

Acceptance Criteria (Implied by 510(k) for Substantial Equivalence)	Reported Device Performance
Mechanical Properties:	Testing demonstrated equivalent insertion and fixation properties.
(e.g., insertion force, fixation strength, tensile strength)	(Specific quantitative values are not provided in this summary document.)
Biocompatibility:	Materials (PEEK with polyethylene suture) are the same as the predicate and
(e.g., material safety, non-toxicity)	are well-established for medical implants.
Sterilization:	Same sterilization method (EO) as the predicate device.
Intended Use & Indications for Use:	Identical to the predicate device.
Device Design/Principles of Operation:	Similar (Screw-in suture anchor for proposed vs. Tap-in/Screw-in anchor
	for predicate).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is typically not included in a 510(k) summary for a non-AI/ML device. The "test set" here refers to the samples used in bench testing. The document does not specify the number of anchors tested, nor the provenance of such test data (e.g., in-house lab, third-party lab). It's bench test data, not 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)

This is not applicable for a traditional medical device 510(k). "Ground truth" in the context of this device would relate to the physical and mechanical properties demonstrated through laboratory testing, not expert interpretation of medical images or clinical outcomes.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for mechanical bench testing of an orthopedic implant.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for this device is established through standards-based mechanical and physical testing. For example, tensile strength measured against an ASTM standard, or insertion force measured using a universal testing machine. The document mentions "performance testing conducted demonstrates that the insertion and fixation properties... is substantially equivalent." This implies laboratory measurements against accepted material and mechanical engineering principles.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no "training set" in the context of a physical medical implant's 510(k) submission.

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

Not applicable. As above, no training set for this type of device.

Summary of the Study Discussed (510(k) Submission):

The "study" described in the provided text is a 510(k) premarket notification for the Smith & Nephew TWINFIX Ultra PK Suture Anchor. The primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (Smith & Nephew TWINFIX PK FT Suture Anchor, K072875).

Type of Study: Non-clinical (bench) performance testing and comparative analysis with a predicate device. This is not an AI/ML device study.
Objective: To show that the new device has equivalent safety and effectiveness to the predicate device, specifically regarding its "insertion and fixation properties."
Methodology: The document states, "The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew TWINFIX Ultra PK suture anchor is substantially equivalent to the predicate TWINFIX FT PK suture anchor, cleared via K072875." It also notes that "differences in the new device and the predicate device do not raise any new issues of safety and efficacy."
Key Findings: The device was deemed substantially equivalent to the predicate, and cleared by the FDA (K093228).
Limitations (for AI/ML context): This document is a summary and does not provide detailed quantitative results, specific test protocols, or the number of samples used in the bench testing. It strictly focuses on the regulatory requirement of demonstrating substantial equivalence for a physical medical device.

Summary

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Traditional 510(k) Section IV

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 TWINFIX Ultra PK Suture Anchor

Date Prepared: October 14, 2009

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover MA, 01810

B. Company Contact

Christina Flores Regulatory Affairs Specialist II (508) 261-3705 Phone: FAX: (508) 261-3620

C. Device Name

Trade Name:	TWINFIX Ultra PK Suture Anchor
Common Name:	Suture Anchor
Classification Name:	Fastener, fixation, non-degradable, soft tissue

D. Predicate Devices

The Smith & Nephew TWINFIX Ultra PK Anchor is substantially equivalent in Intended Use and fundamental scientific technology to the legally marketed Smith & Nephew TWINFIX PK FT Suture Anchor cleared via K072875.

E. Description of Device

Image /page/0/Picture/18 description: The image contains the word "MATION" in large, bold, black font. The text is simple and isolated against a white background. The word appears to be a fragment, possibly part of a larger word or phrase.

1093228

DEC 1 5 2009

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F. Intended Use

The Smith & Nephew TWINFIX Ultra PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder:

Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis

Foot/Ankle:

Hallux valgus repairs repairs/reconstructions Medial or lateral instability Achilles tendon repairs/reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquious advancement Illiotibial band tenodesis.

Elbow:

Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Metatarsal ligament/tendon repairs/reconstruction Midfoot reconstructions

G. Comparison of Technological Characteristics

Device Characteristics	TWINFIX FT PKPredicate Device	TWINFIX Ultra PKProposed Device
Device Design/Principles ofOperation	Tap-in/Screw-in anchor	Screw-in suture anchor
Materials	PEEK with polyethylenesuture	PEEK with polyethylenesuture

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Sterilization Method	EO	EO
Intended Use	Attachment of soft tissue to bone	Attachment of soft tissue to bone
Indications for Use	Reattachment of soft tissue to bone inShoulder:Bankart lesion repairsSlap lesion repairsCapsular shift or capsulolabralreconstructionsAcromioclavicular separation repairsDeltoid repairsRotator cuff tear repairsBiceps tenodesisFoot/Ankle:Hallux valgus repairsMedial or lateral instabilityrepairs/reconstructionsAchilles tendonrepairs/reconstructionsMidfoot reconstructionsMetatarsal ligament/tendonrepairs/reconstructionKnee:Extra-capsular repairs:Medial collateral ligamentLateral collateral ligamentPosterior oblique ligamentPatellar realignment and tendonrepairs:Vastus medialis obliquiousadvancementIlliotibial band tenodesis.Elbow:Ulnar or radial collateral ligamentreconstructionsLateral epicondylitis repairBiceps tendon reattachment	Reattachment of soft tissue to bone inShoulder:Bankart lesion repairsSlap lesion repairsCapsular shift or capsulolabralreconstructionsAcromioclavicular separation repairsDeltoid repairsRotator cuff tear repairsBiceps tenodesisFoot/Ankle:Hallux valgus repairsMedial or lateral instabilityrepairs/reconstructionsAchilles tendonrepairs/reconstructionsMidfoot reconstructionsMetatarsal ligament/tendonrepairs/reconstructionKnee:Extra-capsular repairs:Medial collateral ligamentLateral collateral ligamentPosterior oblique ligamentPatellar realignment and tendonrepairs:Vastus medialis obliquiousadvancementIlliotibial band tenodesis.Elbow:Ulnar or radial collateral ligamentreconstructionsLateral epicondylitis repairBiceps tendon reattachment

H. Summary Performance Data

The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew TWINFIX Ultra PK suture anchor is substantially equivalent to the predicate TWINFIX FT PK suture anchor, cleared via K072875. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.

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Image /page/3/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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is depicted in a simple, abstract manner with flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Smith & Nephew Inc., Endoscopy Division % Ms. Christina Flores Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810

DEC 1 5 2009

Re: K093228

Trade/Device Name: Smith & Nephew TWINFIX Ultra PK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded bone fixation fasteners Regulatory Class: Class II Product Code: MBI Dated: October 14, 2009 Received: October 15, 2009

Dear Ms. Flores:

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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Christina Flores

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joxutii 3

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Ko9 3228 510(k) Number (if known):

Device Name: Smith & Nephew TWINFIX Ultra PK Suture Anchor

Indications For Use:

The Smith & Nephew TWINFIX Ultra PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder:

Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis

Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions

Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquious advancement Illiotibial band tenodesis.

Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

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)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Division sign-off)	MXM
Division of Surgical, Orthopedic,

and Restorative Devices

510(k) Number K093228

P, lot 1

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.