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The Stryker All-PEEK Knotless Anchor System is intended to be used for soft-tissue to bone fixation in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

It is indicated for use in the following procedures:

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

Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair and Bunionectomy

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Secondary Fixation for ACL/PCL Reconstruction or Repair

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

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capsular Repair, Acetabular Labral Repair

The Stryker All-PEEK Knotless Anchor System (herein referred to as the proposed device(s)) consists of poly-ether-ether-ketone (PEEK) cannulated screws with a separate eyelet. The anchor system is designed for insertion of the eyelet and screw into bone either directly or by using instrumentation for creation of a pilot hole. Alternatively, screws may be used without the eyelet for suture fixation in a pre-drilled pilot hole by means of a cannulated screwdriver. Screws and eyelets may be provided either preloaded on respective disposable screwdrivers and inserters, or separately for manual loading. A suture threader is included with the eyelet inserter to facilitate loading of suture through the eyelet. Anchor systems are provided sterile and are packaged in single-use sterile barrier systems (SBS) that include one or more screws with or without evelets.

This document describes the premarket notification (510(k)) for the Stryker All-PEEK Knotless Anchor System. Unlike AI/ML medical devices, this is a traditional medical device (an implantable anchor system), and as such, the information requested regarding AI/ML device testing (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable.

The acceptance criteria and the study proving the device meets these criteria are focused on the mechanical and biocompatibility performance of the physical device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in a table format, but it describes the types of tests conducted and their qualitative outcomes. The primary performance characteristic evaluated for this type of device is its mechanical strength, specifically pull-out strength, and its biocompatibility.

Study Details (Applicable to Traditional Medical Devices)

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated. The document mentions "The proposed devices" and "predicate devices," implying multiple units were tested. The specific number of units tested for ultimate tensile strength, insertion, pyrogenicity, and endotoxins is not provided.
   • Data Provenance: The studies were benchtop non-clinical tests conducted by Stryker. There is no patient data involved, so concepts like "country of origin" or "retrospective/prospective" are not applicable.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

   • This is not applicable for a traditional mechanical device. "Ground truth" in this context would be the objective measurement of physical properties (e.g., force in Newtons for pull-out strength) using validated test methods and equipment, not subjective expert assessment. The engineers and technicians performing the tests would be qualified in mechanical testing and material science.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data (e.g., medical images). Here, the evaluation is based on objective, quantifiable physical measurements, not interpretation.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No, not applicable. MRMC studies are used for evaluating diagnostic or prognostic devices where human interpretation of data (e.g., images) is involved. This device is a surgical implant.

5. If a Standalone Performance Study (i.e. algorithm only without human-in-the-loop performance) was done:

   • No, not applicable. This refers to AI/ML algorithm performance. The "device" here is a physical implant. Its "standalone performance" is its mechanical integrity and biocompatibility, which was indeed evaluated in the benchtop studies.

6. The Type of Ground Truth Used:

   • The "ground truth" for this device's performance is objective physical and chemical measurements obtained through standardized engineering and biocompatibility testing. For instance, the "ground truth" for pull-out strength would be the measured force required to pull out the anchor from a bone substitute, compared against a validated standard or predicate device performance. For biocompatibility, it's the measured levels of pyrogens and endotoxins against established thresholds.

7. The Sample Size for the Training Set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable.

Conclusion

The acceptance criteria for the Stryker All-PEEK Knotless Anchor System, as presented in the 510(k) summary, revolve around demonstrating substantial equivalence to an existing predicate device based on its intended use, indications for use, material composition, general design, operational principle, and crucially, equivalent or superior mechanical and biocompatibility performance through non-clinical benchtop testing. The document states that the proposed device demonstrated "equivalent or higher pull-out strength to the predicate devices" and passed biocompatibility tests, indicating it met the necessary performance criteria for 510(k) clearance.

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