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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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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, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
• 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity; and, 3.
• 4. revision procedures where other treatments or devices have failed

The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.

• . 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.

The provided text describes a 510(k) premarket notification for a medical device, the PROFEMUR® Z Revision Hip Stem. It does not contain information about acceptance criteria, device performance, or a study demonstrating the device meets such criteria in the way typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the cornerstone of the 510(k) pathway for many Class II medical devices.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) submission. This document does not present acceptance criteria for a specific performance metric (like accuracy, sensitivity, specificity for an AI algorithm) nor does it report such performance. The clearance is based on substantial equivalence, not on meeting predefined performance thresholds from a clinical trial in humans.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. There was no "test set" in the context of clinical performance evaluation for this 510(k). The evaluation involved nonclinical testing of the device hardware.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. There was no ground truth for a test set established by experts in this submission.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. A MRMC study is typically for evaluating the impact of AI on human reader performance, which is not relevant for this revision hip stem.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done

Not applicable. This device is a physical hip stem, not an algorithm.

7. The Type of Ground Truth Used

Not applicable.

8. The Sample Size for the Training Set

Not applicable. Again, this is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of Device Evaluation for K121221 (PROFEMUR® Z Revision Hip Stem):

• Acceptance Criteria & Performance: The acceptance criteria for this 510(k) submission revolved around demonstrating substantial equivalence to predicate devices. This means proving that the new device is as safe and effective as a legally marketed device. The "performance" assessment was primarily through nonclinical testing (mechanical fatigue evaluation) and comparison of design features and materials to predicate devices.
  • 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. The assumption is that the device met the requirements of these ISO standards, thereby demonstrating acceptable mechanical performance equivalent to other devices cleared under these standards. The specific results (cycles to failure, load limits, etc.) are not detailed in this summary but would have been part of the full submission.
• Study Type: The submission relies on nonclinical testing (fatigue evaluation) and a comparative analysis of design features, materials, and intended use against predicate devices (STEM Hip Replacement System K021346 and PRESERVE HIP STEM K112080).
• Clinical Data: Explicitly stated: "Clinical data was not provided for the class II hip stem." This indicates no human clinical trials were performed for this specific submission to demonstrate safety and effectiveness, as it was deemed unnecessary due to substantial equivalence.
• Ground Truth/Training Data: Not applicable as this is a physical implant and not an AI/ML algorithm.

Conclusion from the document: The FDA found the PROFEMUR® Z Revision Hip Stem to be substantially equivalent to its predicate devices based on:
* Identical indications for use.
* Similar design features and materials.
* The same fundamental scientific technology.
* Adequate support from "substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."

This 510(k) successfully navigated the regulatory pathway by demonstrating that the changes were minor enough (e.g., increased distal stem length, two new sizes) and supported by nonclinical mechanical testing, making a full clinical trial for performance unnecessary.

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