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General Indications:
The MobileLink® Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
Indications:

• 1. Primary and secondary osteoarthritis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformities
• 4. Avascular necrosis
• 5. Femoral neck fractures

6. Revision after implant loosening dependent on bone mass and quality

The subject devices are 6.5mm diameter acetabular bone screws in various lengths manufactured from Ti6Al4V alloy. They are accessories to the predicate MobileLink® Acetabular Cup System (K182321).

This document (K192559) describes the 510(k) premarket notification for "Acetabular Bone Screws (for MobileLink Acetabular Cup System)". It's important to note that this document is for a medical device (bone screws), not an AI or software device. Therefore, the requested information regarding acceptance criteria and studies for an AI/software device does not apply to this submission.

The document discusses the substantial equivalence of the bone screws to predicate devices based on:

• Device Description: 6.5mm diameter acetabular bone screws in various lengths manufactured from Ti6Al4V alloy. They are accessories to the MobileLink® Acetabular Cup System.
• Intended Use: The MobileLink® Acetabular Cup System (with which these screws are used) is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures, including primary and secondary osteoarthritis, rheumatoid arthritis, correction of functional deformities, avascular necrosis, femoral neck fractures, and revision after implant loosening.
• Comparison to Predicate Device: The subject screws provide supplemental screw fixation for acetabular shells, are manufactured from the same Ti6Al4V alloy as the predicate, are available in Ø 6.5mm and various lengths, and minor technological differences do not raise new questions of safety or effectiveness.
• Performance Testing (Non-Clinical):
  • Bone screw testing according to ASTM F543.
  • Endotoxin testing.
  • Biocompatibility evaluation.
• Clinical Testing: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device."

Therefore, I cannot provide the requested information related to AI/software device acceptance criteria and study details because this document does not pertain to such a device.

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