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The Healix Ti Anchor is intended for:

• 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
• Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Hip: Capsular Repair, Acetabular Labral Repair

The Healix Ti™ Anchor with Permacord™ is a non-absorbable suture anchor preloaded on a disposable inserter assembly intended for fixation of suture to bone. The Healix Ti Anchors are manufactured of Titanium material. Permacord suture is non-absorbable. The anchor is provided in three sizes: 4.5mm, 5.5mm and 6.5mm. The Healix Ti Anchor with Permacord suture is supplied sterile and is for single use only.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device, nor does it provide specific numerical performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device through various non-clinical tests.

2. Sample Size Used for the Test Set and the Data Provenance

The document mentions "Verification activities were performed on the implant and / or its predicates. Testing assessment includes pull out testing." However, it does not provide any details regarding the sample size used for these tests, nor the data provenance (country of origin, retrospective or prospective). Given the nature of a 510(k) summary, these granular details are often found in the full submission, not the publicly available summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this document. The device in question is a medical implant (suture anchor), not an AI or diagnostic device that requires expert review for ground truth establishment. The "ground truth" for this device would be its physical and mechanical performance characteristics.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above.

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 as the device is a medical implant, not an AI or diagnostic tool that would involve human readers.

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

This is not applicable as the device is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering and mechanical testing data, primarily "pull out testing" to demonstrate its fixation strength in bone. It also relies on the established performance and safety record of its predicate devices.

8. The Sample Size for the Training Set

This is not applicable as the device is hardware (medical implant) and not an AI algorithm that would require a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable as the device is hardware and does not have a training set or associated ground truth in the context of machine learning.

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