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The CONSERVE® Total Femoral Head 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 CONSERVE® Total Femoral Head is intended for single patient use only.

Manufactured from wrought cobalt-chromium-molybdenum .
The articulating surface of the implants will be superfinished .
Available sizes: 36mm, 38mm, 42mm, 42mm, 46mm, 48mm, 50mm, 52mm, 52mm, . 54mm, 56mm
The taper connection is identical to previously cleared taper connections and is . intended to be used with our existing femoral stems manufactured with WMT12/14 taper.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance for CONSERVE® Total Femoral Head

The acceptance criteria for the CONSERVE® Total Femoral Head are primarily focused on its wear performance compared to a predicate device, the Metal TRANSCEND® Femoral Head.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The marketing claims present a ratio of improvement, while the reported performance provides a difference in absolute volumetric wear. The document implies that the 1.02 mm³ difference at 5 million cycles in favor of the CONSERVE® head is sufficient to meet the spirit of the acceptance criteria, particularly the cumulative volumetric wear claim. However, a precise calculation to verify the "3.2 times lower" claim based only on the 1.02mm³ difference and without knowing the absolute wear of the control device is not possible with the given information.

2. Sample Size and Data Provenance for the Test Set

• Sample Size:
  • The document states, "Both the test and control devices were 54mm diameter femoral heads." It also notes, "The hip simulators used were orbital bearing hip wear test machines manufactured by Shore Western Manufacturing, Inc." This phrasing suggests a limited number of devices were tested on these machines. While not explicitly stated, it's common for such in vitro wear tests to use a small number of samples (e.g., n=3 or n=6 for test and control groups) run in parallel on a simulator. The exact number of samples is not provided.
• Data Provenance: The data is from in vitro hip wear simulator tests. The country of origin for the data is not specified, but the applicant (Wright Medical Technology, Inc.) is based in Arlington, Tennessee, USA, suggesting the testing was likely conducted in the USA. The study is retrospective in the sense that the testing was completed prior to the 510(k) submission.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This is an in vitro mechanical wear test, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the objectively measured volumetric wear using established laboratory methods.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro mechanical test with objective measurements, there is no need for expert adjudication.

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

No. This is not an imaging or diagnostic device. The study described is an in vitro mechanical wear test, not a clinical study involving human readers.

6. Standalone Performance Study

Yes, in a sense. The wear test described is a standalone in vitro performance study of the device itself (algorithm only, if one were to stretch the analogy, as it's purely mechanical performance). It measures the wear of the CONSERVE® Total Femoral Head and compares it directly to the Metal TRANSCEND® Femoral Head without human intervention in the measurement process.

7. Type of Ground Truth Used

The ground truth used is objective quantitative measurement of volumetric wear obtained through controlled in vitro hip wear simulator tests. This is a form of engineering or laboratory "ground truth."

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The study focuses on direct mechanical performance testing.

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

Not applicable, as there is no training set for this type of device and study.

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