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Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.

A surgeon will request a PMI hip stem over a standard line product in order to better fill the patient's natural femoral canal. The most common parameters modified include the expansion of the A-P diameter, the increase of the lateral flare of the device and the posterior bowing of the stem. The resulting device will more closely match the patient's natural anatomy. Since each stem is matched to a particular patient, a specific device description is unavailable. Instead, an envelope has been defined which all devices must fit.

The provided text is a 510(k) premarket notification summary for a medical device, the HA PMI Femoral Hip Stem. It states that no clinical testing was provided for this device. Therefore, a study demonstrating the device meets specific acceptance criteria, as well as information about sample sizes, ground truth establishment, expert qualifications, and adjudication methods, are not available in the provided document.

The primary method used for demonstrating safety and effectiveness for this device was non-clinical testing, specifically "Mechanical testing and engineering analysis has justified the modifications to this device." This device was approved based on substantial equivalence to a legally marketed predicate device (PMI Hip Femoral - 510(k) K923452), meaning it was deemed as safe and effective as a previously cleared device without requiring new clinical trials to prove its performance.

Since no clinical study was cited, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable as no clinical study was conducted.
2. Sample sized used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
6. If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: Not applicable (this 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.
9. How the ground truth for the training set was established: Not applicable.

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