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The ELEOSTM Bipolar Acetabular System is indicated for the following conditions:

1. pathological fractures of the femoral neck
2. non-union of femoral neck fractures
3. aseptic necrosis of the femoral head and neck
4. primary pathology involving the femoral head or femur but with a non-deformed acetabulum.

ELEOS™ Bipolar Acetabular System is a bipolar hip implant design that features a cross-linked polyethylene bearing surface with a lock detail enhanced for strength. Historical concerns with traditional bipolar designs have included loosening of the insert, disassociation of the head from the shell, and osteolysis resulting from polyethylene wear. This system is designed to address these concerns to give surgeons greater confidence when using a bipolar implant.
There is an UHMWPE support ring inside the shell that is permanently fixed. There is also an UHMWPE locking ring that assembles above the support ring and locks into place once the head is inserted into the shell. Bipolar heads are available in a variety of diameters with corresponding internal diameters for 22, 28, 32 and 36mm femoral heads with skirts are not compatible with the bipolar shells.

The provided text is a 510(k) summary for the ELEOS™ Bipolar Acetabular System. It states that no performance data for the subject device (ELEOS™ Bipolar Acetabular System) is provided. Instead, the submission relies on the substantial equivalence principle, asserting that the subject device has the same materials, technology, and sterilization methods as the predicate device (GLADIATOR® Bipolar System, K062693).

Therefore, I cannot extract information about acceptance criteria and a study proving the device meets those criteria from this document. The document explicitly states:

"No performance data is provided. A copy of the full 510(k) for the predicate device (K062693) is provided because there are no technological differences between the subject and predicate devices."

As such, I cannot populate the table or answer the specific questions about sample size, provenance, experts, adjudication, MRMC studies, standalone performance, ground truth types, or training set details, as this information is related to performance data that is explicitly stated to be not provided for the subject device in this document.

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