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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.

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.

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.

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