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The PROFEMUR® E Cementless Hip Stem is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications For Use:
The PROFEMUR® E Cementless 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:

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 PROFEMUR® E Cementless 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® E Cementless Hip Stems 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 possesses 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® E Cementless Hip Stem is made of the same Titanium alloy and features a corundum blast surface finish similar to the PROFEMUR® Z Hip Stem (K021346). The PROFEMUR® E Cementless Hip Stem shares the rectangular cross-section of the predicate devices, and is designed to feature additional tapered lateral fins on each stem side.

Here's an analysis of the provided text regarding the PROFEMUR® E Cementless Hip Stem, focusing on the acceptance criteria and the study proving it.

Important Note: The provided text is a 510(k) Summary. A 510(k) submission generally aims to demonstrate substantial equivalence to a predicate device, rather than proving that a new device independently meets specific performance acceptance criteria through clinical studies. The focus is on showing the new device is as safe and effective as a legally marketed predicate device. Therefore, the "acceptance criteria" here are implicitly related to demonstrating this substantial equivalence, and the "study" is primarily non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the 510(k) summary, the device's acceptance criteria are framed in terms of its substantial equivalence to the predicate device, particularly in its mechanical performance.

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

• Sample Size for Test Set: Not explicitly stated as a number of devices or clinical subjects. The testing was non-clinical (i.e., laboratory testing on devices).
• Data Provenance: The document does not specify a country of origin for the data beyond stating "Wright Medical Technology, Inc. 5677 Airline Rd. Arlington, TN 38002" as the submitter. The testing itself involved mechanical evaluations of the device, not clinical data from patients. The study was non-clinical non-human.

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

Not applicable. This was a non-clinical, mechanical evaluation comparing a device to a predicate. It did not involve expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical, mechanical evaluation.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data was not provided for the class III modular hip stem."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical, implantable medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established mechanical performance and material specifications of the predicate device (PROFEMUR® Z Hip Stem, K021346) and other previously cleared PROFEMUR® hip stems. The new device's performance was compared against these established standards.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of non-clinical mechanical testing of a medical implant.

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

Not applicable. See point 8.

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