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General Indications:
The MobileLink Acetabular Cup System is indicated for mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Indications:

• Primary and secondary osteoarthritis
• Rheumatoid arthritis
• Correction of functional deformities
• Avascular necrosis
• Femoral neck fractures
• Revision after implant loosening dependent on bone mass and quality

Dual Mobility Insert (in addition to the indications and general indications):

• Dislocation risk

The MobileLink Acetabular Shells are intended for cementless fixation.

The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

Additional indications specific to the TrabecuLink Augments:

• Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system.

MobileLink PlasmaLink and TiCaP Shells: The MobileLink System consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either titanium plasma sprayed (TPS) coating (brand name: PlasmaLink) or a double coating consisting of titanium plasma spray coating plus calcium phosphate (CaP) coating (brand name: TiCaP). The MobileLink PlasmaLink and TiCaP Shells are compatible with polyethylene liners (K182321, K241636), acetabular bone screws (K192559), Dual Mobility Inserts (K200607) with BiMobile Dual Mobility Liners (K171273, K190535), Shell/Insert Adapters ("Face Changers", K200607), and TrabecuLink Augments (K241636).

This FDA 510(k) clearance letter is for a medical device called the "MobileLink Acetabular Cup System - inhouse coatings." It does not involve AI software and therefore does not have the acceptance criteria and study information typically associated with AI/ML-based devices.

The submission is specifically for a change in the coating supplier for an existing device from an external vendor to an in-house process. This means the core design and function of the acetabular cup system are already established and cleared.

Therefore, the requested information elements (acceptance criteria table, sample size for test set, experts for ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size, how training ground truth was established) are not applicable to this specific 510(k) submission.

Here's why and what information is provided:

• Device Type: This is a physical orthopedic implant (hip replacement component), not an AI/ML software device.
• Reason for Submission: The primary reason for this 510(k) is to notify the FDA of a change in the manufacturing process (in-house coating application instead of external). This is a manufacturing/materials change, not a new device with new performance claims requiring extensive clinical or AI performance studies.
• Performance Testing: The document states:
  • "Non-clinical performance testing and analysis were provided, including: Characterization of the TPS and TiCaP inhouse coatings."
  • "Biocompatibility evaluation."
  • "The results of non-clinical performance testing demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent."
  • "Clinical performance testing was not required to demonstrate the substantial equivalence of this device."

This means the acceptance criteria and supporting studies were focused on material characterization and biocompatibility to ensure the new in-house coating process yields a product that is equivalent to the predicate device in terms of safety and performance (e.g., adhesion, wear resistance, biological response), rather than diagnostic accuracy or human-AI interaction.

In summary, there is no information in this document to answer the questions about acceptance criteria related to AI/ML performance studies, as this is not an AI/ML device submission.

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