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The Citrespline™ and Citrelock™ ACL Implants are 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 Repair, Bankart Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus 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 Citregen Tendon Interference Screw and CitreLock are 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 Repair, Bankart Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus 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 subject devices are comprised of CITREGEN biomaterial, which is a 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 CITREGEN™ Tendon Interference Screw (TIS) and CITRELOCK™ Tendon Fixation Device are fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm. There are two designs: 1) a traditional tapered, blunt threaded and cannulated screw that is screwed into the prepared bone and 2) a "twist-ribbed" cannulated, self-locking device (trade named Citrelock™) that is inserted into bone. Citregen TIS and Citrelock implants attach soft tissue to bone for surgical procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist. Select single use manual instruments are packaged together with an implant in a sterile "kit" configuration (Xpress Kit). There is an additional subset of sterile single use instruments to facilitate surgery (Prep Kit). Alternatively, there is a set of reusable instruments.

THE CITRESPLINE™ and CITRELOCK™ ACL Implants are bone anchor devices ranging in diameter from 7 to 12 mm in 1 mm increments, and lengths of 23, 28, and 33 mm. There are two designs for the system: 1) "twist-ribbed" cannulated, self-locking devices (CITRELOCK ACL) and 2) a "straight spline" style device (CITRESPLINE). Both designs have a cannula through the central axis for alignment into the surgically prepared site. Surgical placement is facilitated with a reusable set of instruments.

The provided text is a 510(k) summary for medical devices (Tendon Interference Screws and ACL Implants) and focuses on demonstrating substantial equivalence, specifically regarding a change in sterilization method (from EtO to gamma radiation). It is NOT an AI/ML device submission.

Therefore, the document does not contain any information about:

• Acceptance criteria for an AI/ML device's performance.
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for test sets in an AI/ML context.
• Data provenance for AI/ML training/test sets.
• Number of experts or their qualifications for establishing ground truth in AI/ML.
• Adjudication methods for AI/ML ground truth.
• MRMC studies for AI/ML.
• Standalone AI/ML performance.
• Types of ground truth for AI/ML.
• Training set sample sizes for AI/ML.
• How ground truth for an AI/ML training set was established.

The document is entirely about physical medical devices and their material properties, biocompatibility, and sterility after a change in manufacturing process (sterilization method).

To answer your request, I would need a different document that details an AI/ML medical device submission.

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