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The Knotilus+ PEEK Knotless Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures:

2.4x11.3mm, 2.9x12.5mm, and 2.9x15.5mm:

Shoulder: Rotator Cuff Repair. Bankart Repair. SLAP Lesion Repair. Biceps Tenodesis. Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift, or Capsulolabral Reconstruction Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament and Tendon Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand and /Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair Hip: Acetabular Labral Repair

2.4x8.9mm:

Hip: Acetabular Labral Repair

The Knotilus+ PEEK Knotless Anchors (herein referred to as the subject device(s)) are bone anchors with a push-in mechanism. The subject device system is comprised of a poly-ether-etherketone (PEEK) eyelet and anchor, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS).

The provided text is a 510(k) premarket notification clearance letter for the Stryker Endoscopy Knotilus+ PEEK Knotless Anchor. It details the device's intended use, regulatory classification, and a summary of performance testing and conclusions regarding its substantial equivalence to predicate devices. However, the document does not contain the kind of detailed information typically found in a study report for an AI/software device, such as specific acceptance criteria for performance metrics, detailed sample sizes for training or test sets, data provenance, expert qualifications, adjudication methods, or MRMC study results.

The device in question, the Knotilus+ PEEK Knotless Anchor, is a physical medical device (a bone anchor) and not an AI or software-driven device. Therefore, the questions related to AI/software performance criteria, ground truth, expert adjudication, and MRMC studies are not applicable to this submission.

Here's a breakdown of the information that can be extracted relevant to the device and its testing, and why other requested information is not present:

1. Table of acceptance criteria and the reported device performance

Study that proves the device meets the acceptance criteria:

The document states: "Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Knotilus+ PEEK Knotless Anchor, including ultimate tensile strength (UTS) and insertion testing." It also mentions "Bacterial endotoxin testing was performed on the Knotilus+ PEEK Knotless Anchor".

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 provided in the 510(k) summary. These details are typically found in a full test report, which is not part of this clearance letter. Given this is a physical device, "data provenance" like country of origin for clinical data or retrospective/prospective studies is generally not applicable to bench testing, which uses manufactured device samples.

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 is not applicable as this is a physical medical device, not an AI/software device requiring "ground truth" established by human experts in the context usually meant for AI. The performance testing (tensile strength, insertion, endotoxin) are objective measurements performed in a laboratory setting according to engineering and bioload testing standards.

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

Not applicable for a physical medical device. Adjudication methods are relevant for subjective assessments, often in clinical trials or AI performance evaluations, not for objective benchtop engineering tests.

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. MRMC studies are used to evaluate diagnostic imaging systems or AI software performance in clinical settings. This device is a surgical implant, and no such study type would be relevant to its clearance.

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

Not applicable. This is not an algorithm or software device.

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

Not applicable. For physical benchtop testing, the "ground truth" is typically the quantitative measurement obtained through calibrated testing equipment using established engineering and material science methodologies. For example, the "ground truth" for ultimate tensile strength is the physical force recorded by the testing machine at the point of failure.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model requiring a training set and associated ground truth establishment.

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