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The Arthrex Biocomposite Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically;

• Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
• Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Knee: Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
• Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: 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 Arthrex Biocomposite Interference Screws are intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone.

This document is a 510(k) summary for the Arthrex Biocomposite Interference Screw. It describes the device's intended use and claims substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory submission for premarket notification, not a study report detailing performance metrics against specific acceptance criteria.

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The Arthrex Interference Screws are intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Interference fixation with PEEK, Titanium, or Bioabsorbable Polymer Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically;

• Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
• Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial 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 Arthrex Interference Screws are intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Interference fixation with PEEK, Titanium, or Bioabsorbable Polymer Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate.

The provided document is a 510(k) summary for a medical device called the "Arthrex Interference Screw." This type of document is for clearance of a device based on substantial equivalence to a predicate device, not for a de novo FDA approval which would typically involve clinical studies proving acceptance criteria for performance.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving a device meets them for an AI/ML or imaging-based medical device.

Here's why and what the document does provide:

• Device Type: The "Arthrex Interference Screw" is a physical orthopedic implant (a fixation device for ligaments/tendons to bone), not an AI/ML, software, or imaging-based device.
• Regulatory Pathway: A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, materials, and intended use, and may include bench testing, but typically does not require new clinical studies to establish performance acceptance criteria against human readers or a set ground truth in the way an AI/ML product would.
• Lack of Specific Information: Consequently, the document does not mention:
  • Acceptance criteria for an algorithm's performance (e.g., sensitivity, specificity, accuracy).
  • Sample sizes for test sets or training sets.
  • Data provenance (country, retrospective/prospective) for a study.
  • Number or qualifications of experts for ground truth.
  • Adjudication methods.
  • MRMC comparative effectiveness studies.
  • Standalone algorithm performance.
  • Type of ground truth used (pathology, outcomes, expert consensus) for algorithm validation.
  • How ground truth was established for a training set.

What the document does describe is:

• Intended Use: Fixation of tissue (ligament/tendon to bone and bone tendon bone) in various anatomical locations (knee, shoulder, elbow, ankle, foot, hand/wrist) for specific repairs and reconstructions.
• Device Materials: PEEK, Titanium, or Bioabsorbable Polymer.
• Predicate Device: Arthrex Interference Screw (K052607).
• Substantial Equivalence Claim: The new device is substantially equivalent to the predicate, with any differences considered minor and not raising safety/effectiveness concerns.

In summary, to answer the prompt directly based on the provided text: The document does not describe acceptance criteria for an AI/ML device or a study proving such criteria are met.

Ask a specific question about this device

Ask a specific question about this device