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The Smith & Nephew TWINFIX Ultra Ti Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder:

• Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs . Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
• Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions

Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquous advancement Iliotibial band tenodesis.

Elbow:

• Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

The TWINFIX Ultra Ti is a suture anchor manufactured from Titanium alloy and is offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The anchor is preloaded with suture preassembled onto a stainless steel inserter.

The provided text describes the Smith & Nephew TWINFIX Ultra Ti Suture Anchor and its regulatory clearance, but it does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria, especially in the context of an AI/algorithm-based device.

The document is a 510(k) summary for a medical device (a suture anchor), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a study format often seen for diagnostic or AI devices.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

Missing information: Explicit, quantifiable acceptance criteria. The performance is reported as "substantially equivalent" rather than a specific measure against a target.

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified. The document only states "Non-clinical testing that included insertion and pull-out strength was performed."
• Data provenance: Not specified. Given it's non-clinical testing of a physical device, it would likely be laboratory or bench testing, not patient data from a specific country.
• Retrospective/Prospective: Not applicable in the context of this device's non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable to the type of device and testing described. The "ground truth" for a suture anchor's mechanical performance (insertion and pull-out strength) would be established by direct physical measurement, not by expert interpretation.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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:

• No. This is not an AI/diagnostic device. An MRMC study is not relevant here.

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

• No. This is a physical medical device (suture anchor), not an algorithm.

7. The type of ground truth used:

• For "insertion and pull-out strength," the ground truth would be direct physical measurements using force gauges or similar mechanical testing equipment.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its performance is based on material properties and design, tested mechanically.

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

• Not applicable. See point 8.

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