The Stryker PEEK TwinLoop Tac is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, and shoulder. Specific indications are listed below and are size appropriate per patient needs:

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

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

Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Hand/Wrist: Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers.

Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Foot/Ankle: Ligament Repair, Hallux Valgus Reconstruction, digital tendon transfers, Mid-foot reconstruction.

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

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

Hip: Capsular repair, acetabular labral repair.

The Stryker PEEK TwinLoop Tac is intended for single-use only.

Device Description

The Stryker PEEK TwinLoop Tac is a push-in type implant with two USP#1 high strength suture eyelets pre-threaded with USP#2 non-absorbable braided surgical sutures and pre-assembled on a disposable inserter. The Stryker PEEK TwinLoop Tac will be manufactured from PEEK-OPTIMA® LT3 (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc. The sutures will be USP braided ultra high molecular weight polyethylene (UHMWPE) suture (K033654, K040472 and K063778). The Stryker PEEK TwinLoop Tac will be validated to a SAL of 10th using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7.1995.

AI/ML Overview

The provided text is a 510(k) summary for the Stryker PEEK TwinLoop Tac, a PEEK Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about a clinical study or performance testing against specific acceptance criteria for the device itself.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The document states that the technological and material differences between the Stryker PEEK TwinLoop Tac and the predicate devices "do not affect the safety and efficacy of the product." This statement, along with the device's classification as a Class II orthopedic device, strongly suggests that the FDA's clearance was based on substantial equivalence to existing devices rather than a de novo clinical trial with specific performance criteria.

However, based on the information provided, I can address some of the other points:

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The provided document is a 510(k) summary that establishes substantial equivalence. It does not contain acceptance criteria for specific device performance metrics or the results of a study demonstrating the device meets those criteria. The clearance is based on the device being similar enough to already-marketed devices such that no new questions of safety or effectiveness are raised.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. This document does not describe a clinical performance study with a test set. Substantial equivalence claims for devices like this are often supported by bench testing (mechanical properties, sterilization, biocompatibility) rather than large-scale human clinical trials. The document mentions "The Stryker PEEK TwinLoop Tac will be validated to a SAL of 10-6 using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7.1995." This relates to validation of the sterilization process and biocompatibility, not clinical efficacy or performance in a patient test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. No clinical test set or ground truth establishment by experts is described in this 510(k) summary.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable. No clinical test set or adjudication method is described.

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 device is a PEEK suture anchor, a physical implant, not an AI-driven diagnostic or assistive device. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

Not Applicable. As mentioned above, this is a physical medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not Applicable. No clinical "ground truth" (in the sense of a diagnostic or predictive AI system) is discussed for this device. The "truth" for this type of device is its physical and material properties, and its ability to perform its intended mechanical function, as implied by its substantial equivalence to predicate devices.

8. The Sample Size for the Training Set

Not Applicable. There is no mention of a "training set" as this is not an AI or machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. No training set or associated ground truth establishment is mentioned.

Summary regarding acceptance criteria and study:

The 510(k) summary indicates that the device's substantial equivalence is based on its material composition (PEEK-OPTIMA® LT3), intended use, safety, and efficacy being comparable to the predicate devices (Arthrex PEEK SutureTak and Arthrex Bio-Corkscrew FT). The document does not describe a specific study with defined acceptance criteria for the Stryker PEEK TwinLoop Tac's performance. Instead, it relies on the established safety and efficacy of the predicate devices and demonstrates that the new device does not introduce new questions of safety or efficacy.

The document mentions adherence to various voluntary safety and performance standards (e.g., ISO 10993-1, EN 550, EN 556-1, EN 11607-1, EN 11607-2, EN 980, EN 1041, and EN ISO 14971) and validation of sterilization. These standards and tests are general and not presented as specific acceptance criteria with quantifiable performance results in this summary.

Summary

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K070882 page '92

5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2521

stryker®

Endoscopy

JUL 2 0 2007

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Date: March 30, 2007

Contact Person: Erica A. Walters, RAC Sr. Regulatory Representative 408-754-2078(phone) 408-754-2521 (fax) erica.walters@stryker.com

Device Name:

Proprietary Name:	Stryker PEEK TwinLoop Tac
Common and Usual Name:	PEEK Suture Anchor
Classification Name:	Screw, Fastener, Fixation, Nonabsorbable, Bone, Soft
	Tissue (Class II, 21 CFR 888.3040, Product Code MBI,
	Orthopedics Review Panel)

Predicate Device(s):

Arthrex PEEK SutureTak: K971723, K000506, K050749, K061863 Arthrex Bio-Corkscrew FT: K043337

Device Description and Intended Use:

The Stryker PEEK TwinLoop Tac is intended to be used for suture or tissue fixation in the foot, ankle, knee hip, hand wrist, elbow, and shoulder. Specific indications are listed below and are size appropriate per patient needs:

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

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

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page of

Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Hand/Wrist: Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendoros and PIP, DIP and MCP joints for all digits, digital tendon transfers.

Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Foot/Ankle: Ligament Repair, Hallux Valgus Reconstruction, digital tendon transfers, Mid-foot reconstruction.

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

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

Hip: Capsular repair, acetabular labral repair.

The Stryker PEEK TwinLoop Tac is intended for single-use only.

Prior to introducing the Stryker PEEK TwinLoop Tac to market, the device will conform to the following voluntary safety and performance standards: ISO 10993-1, Blue Book Memorandum G95-1, EN 550, EN 556-1, EN 11607-1, EN 11607-2, EN 980, EN 1041, and EN ISO 14971.

The technological and material differences between the Stryker PEEK TwinLoop Tac, and the Arthrex PEEK SutureTak (K971723, K000506, K050749, K061863), do not affect the safety and efficacy of the product; therefore, the Stryker PEEK TwinLoop Tac is considered substantially equivalent in performance, intended use, safety, and efficacy to the Arthrex PEEK SutureTac.

The Stryker PEEK TwinLoop Tac is considered substantially equivalent in material composition, intended use, safety and efficacy to the Arthrex PEEK SutureTak (K971723, K000506, K050749, K061863).

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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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)". Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2007

Stryker Endoscopy % Mr. K. Jeffrev Semone Director, Regulatory Affairs 5900 Optical Ct. San Jose, CA 95138

Re: K070882

Trade/Device Name: Stryker PEEK TwinLoop Tac Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC, JDR Dated: July 6, 2007 Received: July 9, 2007

Dear Mr. Semone:

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 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 – Mr. K. Jeffrey Semone

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" (21 CFR 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 vours.

Soubayo Spichum

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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page 1 of 1

INDICATIONS FOR USE

Device Name: Stryker PEEK TwinLoop Tac

510(k) Number if known: K070882

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

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

Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Foot/Ankle: Ligament Repair, Hallux Valgus Reconstruction, digital tendon transfers, Mid-foot reconstruction.

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

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

Hip: Capsular repair, acetabular labral repair,

The Stryker PEEK TwinLoop Tac is intended for single-use only.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE

K070882

and Neurological Devices

STRYKER PEEK TWINLOOP TAC 510(K) SUBMISSION

510(k) Number K070882

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.