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The Gladiator Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed.
   The Gladiator cpTi Plasma Sprayed hip stem is intended for cementless hip arthroplasty. The Cemented hip stem is intended for cemented hip arthroplasty.

The Gladiator stems are modular hip stems that couple with modular necks. Design features of the stems are summarized below:

• Cementless stem with proximal cpTi plasma spray coating.
• Available in 10 sizes
• Manufactured from Ti alloy
• Cemented
• Available in 5 sizes
• Manufactured from CoCr alloy
• Distal centralizers available

Acceptance Criteria and Study for PROFEMUR® Gladiator Hip Stems

This section details the acceptance criteria and the study conducted to demonstrate the safety and effectiveness of the PROFEMUR® Gladiator Hip Stems.

1. Table of Acceptance Criteria and Reported Device Performance

"The GLADIATOR® Hip Stems have been tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8." (Implies meeting the standards set by these ISO specifications, which are designed to ensure mechanical integrity for hip implants.) |
| Material Compatibility | Use of materials identical to those used in predicate devices with established safety and performance records. | "The materials used for the GLADIATOR® Hip Stems are identical to the materials used for the predicate devices." |
| Technological Equivalence| The fundamental scientific technology and design features (e.g., modular design, cross-section, tapered profile) are substantially equivalent to predicate devices. | "The GLADIATOR® Hip Stems have the same technological characteristics as the predicate device. GLADIATOR® Hip Stems are straight cemented and uncemented hip stems with a modular design. They feature a proximal trapezoidal cross-section and a distal rectangular cross-section. For fixation stability in three planes, the stem has a vertically tapered profile in the frontal and lateral planes." "The fundamental scientific technology of the modified devices has not changed relative to the predicate devices." |
| Intended Use & Indications| The intended use and indications for use are identical to previously cleared predicate devices. | "The indications for use of the Gladiator Hip Stems are identical to the previously cleared predicate devices." |

2. Sample Size and Data Provenance for the Test Set

• Sample Size: Not applicable. This submission relies on non-clinical (mechanical) testing and comparison to predicate devices, not a clinical test set with human subjects.
• Data Provenance: The mechanical testing data would be generated from laboratory experiments. The country of origin for this testing is not specified, but it would presumably be conducted by or for Wright Medical Technology, Inc., located in Arlington, TN, USA. The data is prospective in the sense that the tests were conducted specifically for this device submission.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: Not applicable. The ground truth for mechanical testing is established by adherence to international standards (e.g., ISO 7206 series) and engineering principles, not expert consensus on clinical cases.
• Qualifications of Experts: Not applicable in the context of clinical ground truth. However, the testing would be overseen by qualified engineers and scientists specialized in biomechanical testing of orthopedic implants.

4. Adjudication Method (Test Set)

• Adjudication Method: Not applicable. No clinical test set requiring adjudication of findings was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No.
• Effect size of human reader improvement: Not applicable, as no MRMC study was conducted. This device is an implantable orthopedic device, and its approval relies on mechanical performance and substantial equivalence to predicate devices, not on the interpretation of medical images or data by human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Was a standalone study done? Yes, in the context of mechanical testing. The device's performance was evaluated in isolation through fatigue, fretting, and distraction tests as per ISO standards. This is a "standalone" evaluation of the physical device's mechanical integrity.
• Details of the study: The GLADIATOR® Hip Stems underwent "distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8," in addition to fretting and distraction evaluation. The results demonstrated equivalence to predicate devices and the capability to withstand in vivo loading.

7. Type of Ground Truth Used (Test Set)

• Type of Ground Truth: The ground truth for this submission is based on adherence to international mechanical testing standards (ISO 7206-4, -6, and -8) and the established safety and effectiveness profile of predicate devices through direct comparison of design features, materials, and mechanical performance. There is no clinical or pathology-based ground truth from a test set of human cases.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device approval is based on a 510(k) submission demonstrating substantial equivalence, primarily through mechanical testing and comparison to existing predicate devices. It does not involve machine learning algorithms or a "training set" in the computational sense.

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

• How Ground Truth Was Established: Not applicable. As there is no training set for a computational model, there is no ground truth to establish for it. The "ground truth" in the broader sense for this submission is derived from the established performance and safety of the predicate devices and the robust mechanical testing standards it adheres to.

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