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The HA PMI Flanged Acetabular Component is indicated for use in patients requiring reconstruction of the hip joint due to disease, deformity or trauma. The device is intended for cementless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. The device is a single use implant. The device is to be used in conjunction with any commercially available femoral component.

A surgeon will request a PMI device over a standard line product in order to better fill the patient's natural anatomy. For example, a Patient Matched Flanged Acetabular Component might be requested in cases of unusual anatomy or extensive bone loss. In such cases, a hemispherical acetabular component, which only has the option of screw fixation in the socket area, may not provide stability that can be obtained through additional screw fixation in the flanges.

Since each cup is matched to a particular patient, a specific device description is unavailable.

The provided text is a 510(k) summary for a medical device, specifically a hip replacement acetabular prosthesis. It states that no clinical testing was provided for this device. Therefore, it is not possible to describe acceptance criteria or a study that proves the device meets them from the given document as no such study was conducted or provided.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Device Description: Highlighting that it's a patient-matched implant for specific anatomical needs or bone loss.
• Intended Use: Defining its purpose in hip joint reconstruction.
• Summary of Technologies: Stating material, design, sizing, and processing similarities to the predicate device.
• Non-Clinical Testing: Mentioning that "Mechanical testing and engineering analysis has justified the modifications to this device," but not providing details or acceptance criteria for these non-clinical tests.

Without clinical testing or detailed non-clinical testing reports, the requested information cannot be extracted.

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