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The CITRELOCK® DUO is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:

Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.

The CITRELOCK® DUO is a two-piece design consisting of a cannulated, self-locking, CITRELOCK® implant made from CITREGEN® biomaterial coupled with an eyelet component made from PEEK. The CITRELOCK® DUO system consists of fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm.

The purpose of this Special 510(k) Device Modification is to advise the FDA of this line extension wherein an eyelet to accommodate suture was added to the previously 510(k) cleared CITRELOCK® "twist-ribbed", cannulated, self-locking bone anchor. The CITRELOCK® DUO device utilizes the same correspondingly sized and designed primary predicate, the CITRELOCK®, with the added PEEK eyelet at the tip of the device. These two components are sterile packaged together and mounted on a Cartridge that facilitates loading onto the Inserter instrument.

The CITRELOCK® DUO is made from CITREGEN® biomaterial, which is a resorbable, homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxyapatite (HA) and 40 wt.-% polyester. CITREGEN's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites.

The eyelet is made from polyether ether ketone (PEEK) conforming to ASTM F2026. Suture material is not provided with the device.

This is a 510(k) summary for a medical device modification, not a study evaluating AI performance. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance with respect to AI (e.g., human reader improvement with AI assistance, standalone algorithm performance, training set details) is not applicable or cannot be extracted from this document.

However, I can provide information based on the performance data presented for this specific medical device modification:

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

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

• Sample size: Not explicitly stated. The document refers to "worst case subject devices (e.g. smallest diameter, shortest length)" being tested.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The testing appears to be lab-based mechanical testing rather than clinical data.

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

Not applicable. Ground truth for mechanical "pull-out" testing is typically established by direct measurement against a predefined standard, not by expert consensus in the way a clinical study would.

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

Not applicable, as this is laboratory mechanical testing and not a clinical image review study.

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. This is a medical device (bone anchor) modification, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is a medical device (bone anchor), not an algorithm.

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

The ground truth for the performance testing appears to be measured mechanical pull-out strength against a specified force, compared to established predicate device performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model.

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

Not applicable. This is a physical medical device, not a machine learning model.

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