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The ICONACY I-Hip is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ICONACY I-Hip consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.

The ICONACY I-Hip consists of a collarless, tapered, forged titanium alloy femoral stem mated to a modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispherical titanium alloy cup (i.e., shell) coupled with a highly cross-linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press-fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press-fit fixation. Titanium bone screws may be used for additional fixation. A titanium locking ring is fixed into grooves on the cup to engage grooves on the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.

The current submission adds ceramic femoral heads in 28, 32 and 36mm diameters and modified CS Acetabular Liners to the system. Compatible femoral stems, acetabular cups, locking rings, bone screws and apex hole plug were cleared in K121034, K131279, K133228 and K132572.

The provided text is a 510(k) summary for the ICONACY™ I-Hip™ Total Hip System, which is a medical device. This document describes the device, its indications for use, and the basis for its substantial equivalence to predicate devices. However, it does not include information about AI/ML algorithms, studies proving device performance against acceptance criteria in the context of an AI/ML algorithm, or details about ground truth establishment, sample sizes for training/test sets, or expert adjudication.

The "PERFORMANCE DATA" section states: "Pre-fatigue burst, fatigue, post-fatigue burst, pull-off, wear testing, wear testing under adverse conditions and biocompatibility testing confirm that the ICONACY I-Hip Ceramic Femoral Heads and CS Acetabular Liners meet pre-determined acceptance criteria and are expected to be safe and effective for the proposed indications."

And "CLINICAL TESTING: Clinical testing was not required to determine substantial equivalence with the predicate devices."

Therefore, I cannot provide the requested information for an AI/ML device because the document describes a mechanical medical device (hip implant) and not an AI/ML algorithm.

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