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The Stryker Intraline Anchor is a soft tissue anchor which will be used for tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis. The anchor is intended 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/Capsulolabral Reconstruction. Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis. Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Pelvis: Bladder Neck Suspension Procedures. The Stryker Soft Eyelet RC Anchor is intended for single-use only.

Each configuration of the Stryker Intraline Anchor Family is a screw-in anchor that is pre-threaded with nonabsorbable USP braided ultra high molecular weight polyethylene (UHMWPE) suture (K033654, K040472 and K063778) and pre-assembled on a disposable inserter. The Stryker PEEK Intraline Anchor will be manufactured from PEEK-OPTIMA® (polyetheretherketone). The Stryker Titanium Intraline Anchor will be manufactured from titanium alloy Ti 6Al 4V EL1. The Stryker Intraline Anchor Family will be validated to a SAL of 10th using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7.

The provided document is a 510(k) Summary for the Stryker Intraline Anchor, a medical device for tissue fixation to bone. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific performance acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance study specifics is not available in this document.

However, I can extract what is implied and stated regarding equivalence and the basis for approval.

Here's a breakdown of the requested information based on the provided text:

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

Based on the document, direct quantitative acceptance criteria and reported device performance are not explicitly stated in a table format. The approval is based on "substantial equivalence" to a predicate device. The general acceptance criteria are implied to be that the device performs equivalently to the predicate and meets relevant safety and performance standards.

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 not available in the provided 510(k) summary. The document does not describe a specific clinical or performance test set with a sample size. The approval is based on equivalence to an already approved device.

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 available. No specific "test set" and thus no experts for establishing ground truth are detailed in this regulatory summary.

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

This information is not available. No specific 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

This is not applicable. The device is an orthopedic surgical anchor, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

This is not applicable. The device is a surgical implant, not an algorithm.

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

This information is not available. As no specific study with a "test set" and a defined ground truth is presented, this cannot be determined from the document. The "ground truth" for regulatory approval in this context is the safety and effectiveness of the predicate device to which the new device is compared.

8. The sample size for the training set

This information is not applicable. The device is a physical surgical implant, not a machine learning algorithm that requires a training set.

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

This information is not applicable. As above, this is not relevant for this type of device.

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