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The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• 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

The PROFEMUR® Z Titanium Plasma Sprayed Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

The modular PROFEMUR® Z Titanium Plasma Sprayed hip stem is an uncemented distal femoral implant designed to couple with Wright Medical Technology's PROFEMUR® CoCr modular necks. The stem design was developed from the previously marketed PROFEMUR® Z Hip Stem ('STEM' K021346) and features the identical modular neck taper socket and is made of the identical Titanium alloy (ASTM F620) as previous hip stem designs by Wright. The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem features the identical substrate cross-sectional geometry as the PROFEMUR® Z Hip Stem (K0213146) with the addition of titanium plasma spray coating conforming to ASTM F1580 applied according to WMT specifications which covers the proximal 1/3 of the stem.

The provided text describes the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem. As a Class III medical device, its clearance is primarily based on demonstrating substantial equivalence to predicate devices rather than meeting specific performance acceptance criteria through clinical or advanced non-clinical studies. The information available focuses on the device's design, materials, and manufacturing being identical or highly similar to previously cleared devices.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those (or is substantially equivalent):

1. Table of Acceptance Criteria and Reported Device Performance

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

The "test set" for this device, as described, primarily refers to non-clinical (bench) testing performed on the device itself, comparing its physical and mechanical properties to established standards and predicate devices.

• Sample Size: Not explicitly stated for each test, but standard engineering tests would involve a sufficient number of samples to ensure statistical validity for the specific test (e.g., typically N=3 to N=5 or more for destructive tests like fatigue).
• Data Provenance: The tests are performed on the manufactured PROFEMUR® Z Titanium Plasma Sprayed Hip Stem. This is prospective testing of the device's physical samples. No human or animal data is described for these non-clinical tests.

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

This information is not applicable in the context of this 510(k) submission. The "ground truth" for the non-clinical tests is established by recognized international standards (ISO, ASTM) and the specifications of the predicate device, not by expert medical opinion on a test set.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication typically refers to the process of resolving discrepancies in expert human reviews for clinical or image-based studies. For non-clinical tests, compliance with standard test methods and evaluation against defined specifications are the "adjudication" mechanism.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This device is a mechanical implant, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

No standalone algorithm performance study was done. This device is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Engineering Standards: ISO 7206-4, 6, and 8 (for fatigue), ASTM F1875 (fretting corrosion), ASTM F2009 (axial disassembly), ASTM F1580 (titanium plasma spray coating).
• Predicate Device Specifications: The design, materials, and surface finish are compared directly to previously cleared predicate devices (e.g., K021346, K012091).
• WMT Specifications: Internal company specifications for manufacturing and coating application.

8. The Sample Size for the Training Set

There is no training set in the context of this 510(k) submission. This is not a machine learning or AI device. The process relies on demonstrating equivalence through engineering analysis and non-clinical testing.

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

Since there is no training set, this question is not applicable.

Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):

The device's "acceptance" for market clearance (through 510(k)) is predicated on demonstrating substantial equivalence to legally marketed predicate devices. The "study" involves a comprehensive comparison and non-clinical testing program:

• Design & Material Comparison: A detailed analysis showing that the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is identical in material (ASTM F620), substrate cross-sectional geometry, modular neck taper socket, and non-coated surface finish to predicate devices (K021346).
• Coating Equivalence: The titanium plasma spray coating is shown to conform to ASTM F1580, applied to WMT specifications, and is "identical" to the coating used on another cleared predicate (K012091). This is supported by testing referenced in a vendor Master File (though specific results are not included in this summary).
• Mechanical Performance Testing: The coated stem underwent standard fatigue tests (ISO 7206-4, 6, and 8) and fretting corrosion and axial disassembly force tests (ASTM F1875 and F2009). While specific pass/fail criteria or results are not detailed in this summary, the completion of these tests in accordance with relevant standards implicitly demonstrates that the device performs acceptably and equivalently to current standards for hip stems.
• Intended Use & Indications Equivalence: The device's intended use and indications for use are stated to be "identical" to existing Wright PROFEMUR® hip stems, which have multiple prior 510(k) clearances.

In essence, the study demonstrating "acceptance" for this device is the body of evidence provided in the 510(k) submission that systematically compares the new device against its predicates and relevant engineering standards, asserting that any differences do not raise new questions of safety or effectiveness. No clinical testing was provided to support this Class III modular hip stem.

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