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The BICON-PLUS Acetabular Components are intended for use in primary and revision total hip arthroplasty where the acetabular socket needs restructuring.

The BICON-PLUS Acetabular Components consists of threaded double cone made out of titanium with a polyethylene insert. Since the double cone corresponds very closely to the anatomical form of the acetabulum, the degree of bone resection in the region of the acetabulum base can be reduced. Two new titanium shells are available: The BICON-PLUS STANDARD cup and the BICON-PLUS POROSE cup. The size, thickness and height of the teeth have been adapted to the size of the cup. In addition to the standard insert, the new hooded version offers an increased support against luxation without compromising the range of motion. The titanium shells come in a range of nine standard sizes (sizes 1-9) and two special sizes (sizes O and 01). The PE inserts come in a range of sizes to match the shells to accommodate three ball head diameters (22mm, 28mm, and 32mm).

The provided text describes a 510(k) submission for the BICON-PLUS Acetabular Components, which are hip prostheses. This device is a physical medical implant, not an AI/ML-driven device or software. Therefore, the questions regarding acceptance criteria, study details, ground truth, and human reader performance are not applicable in the context of this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (OMNIFIT Threaded Acetabular Cup, K-883921). The key performance data mentioned is "Biomechanical Testing," with the statement that "All test results are sufficient for in vivo loading." However, specific acceptance criteria or detailed results of these biomechanical tests are not provided in this document.

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