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Wright Medical total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity; and,
• revision procedures where other treatments or devices have failed.

Rough grit blast surfaces are intended for uncemented arthroplasty. The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.

Design features of the subject stems are summarized below:

• Cementless modular stems
• Available in 9 sizes
• Manufactured from Titanium alloy with a heavy grit blasted surface.

The subject device is available in 9 sizes (from size 3 to 11). Although the proximal geometries are identical to the predicate from size 3-9, the distal stem length has increased, with two larger sizes (10 and 11) introduced.

This submission (K122778) is for a medical device (PROFEMUR® Z Revision Hip Stem) and as such does not contain information on software acceptance criteria or studies involving AI and human readers. The document details the substantial equivalence of the hip stem to previously cleared predicate devices, primarily through nonclinical (mechanical) testing, rather than clinical studies or algorithm performance evaluations.

Therefore, I cannot provide information on:

• Acceptance criteria and reported device performance related to an algorithm.
• Sample size used for the test set or data provenance for an algorithm.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for an algorithm's test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth for an algorithm.
• Sample size for the training set or how ground truth was established for it.

The document explicitly states: "Clinical data was not provided for the class III hip stem." This further confirms that no clinical studies as you've outlined for AI/software evaluation were performed or submitted.

The "acceptance criteria" in this context are for the mechanical performance of the hip stem and its substantial equivalence to existing devices, evidenced by:

1. Nonclinical Testing: The PROFEMUR® Z Revision Hip Stems were tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8. This demonstrates the device's mechanical integrity under specified stress conditions. The acceptance criteria for such tests would be successful completion of these fatigue evaluations without failure, meeting the standards set by ISO 7206.
2. Substantial Equivalence: The primary "study" is the demonstration of substantial equivalence to predicate devices (K021346, K112080, K121221) based on:
   • Identical Indications for Use: The new device shares the exact same intended uses as the predicate devices.
   • Similar Design Features and Materials: The subject device is a cementless modular stem, available in 9 sizes, manufactured from Titanium alloy with a heavy grit blasted surface, similar to the predicates. While distal stem length increased and new sizes were introduced, the fundamental scientific technology remained unchanged.

The conclusion is that the safety and effectiveness are supported by this substantial equivalence information, materials information, and analysis data, aligning with the FDA's 510(k) pathway for medical devices.

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