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The Stryker Omega PEEK Knotless Anchor System is intended 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, Medial 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, Meniscal Root Repair

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

Elbow: Biceps Tendon Reattachment, Temis Elbow Repair, Unar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capular Repair, Acetabular Labral Repair

The Stryker Omega PEEK Knotless Anchor System consists of poly-ether-ether-ketone ("PEEK") cannulated screws with a separate PEEK 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 eyelets.

The provided document describes the predicate device and the modifications made to the original device. It indicates that benchtop testing was conducted to evaluate the performance characteristics of the modified device. However, it does not contain specific acceptance criteria values, reported device performance metrics against those criteria, or details regarding a study that explicitly "proves" the device meets acceptance criteria in the format requested. The document primarily focuses on demonstrating substantial equivalence to a predicate device.

Therefore, much of the requested information cannot be extracted directly from the provided text.

Here is a summary of what can be extracted or inferred based on the available information:

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

The document states:

• "Ultimate tensile strength (UTS) and insertion testing were performed to assess the proposed eyelet modification"
• "cyclic displacement testing was performed to demonstrate that the displacement of the modified Omega anchors is within a clinically acceptable range for meniscal root repair."
• "The modified Omega anchors demonstrated equivalent pull-out strength to the Predicate A devices and equivalent displacement to the Predicate B devices, and no new issues of safety and effectiveness were identified."

However, specific numerical acceptance criteria (e.g., "UTS must be > X Newtons") and the actual reported performance values (e.g., "Achieved UTS = Y Newtons") are not provided in the text. The term "equivalent" is used, indicating a comparative assessment, but the quantitative details are missing.

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

• Sample Size for Test Set: Not specified. The document only mentions "Non-clinical benchtop testing was conducted."
• Data Provenance: The document describes benchtop testing, implying laboratory data. No country of origin is specified for the data, nor is it classified as retrospective or prospective (as it's bench testing, these terms are less applicable).

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 information is not applicable as the study described is non-clinical benchtop testing, not a clinical study involving experts establishing ground truth for diagnostic accuracy.

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

• This information is not applicable as the study described is non-clinical benchtop testing.

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

• This information is not applicable. The device is an orthopedic anchor system, not an AI/imaging diagnostic device that would typically undergo MRMC studies.

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

• This information is not applicable. The device is an orthopedic anchor system.

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

• For the benchtop testing, the "ground truth" would be engineering specifications and established test methodologies (e.g., ISO standards for biocompatibility, material science principles for strength and displacement). No human expert consensus or pathology is involved in this type of testing.

8. The sample size for the training set

• This information is not applicable. There is no "training set" as this is a physical medical device undergoing benchtop performance testing, not a machine learning model.

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

• This information is not applicable for the reasons stated above.

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