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The Cordera™ Hip System may be used with iligs® designed from a patient's pre-operative CT scan, which must include certain necessary anatomic landmarks that are clearly identifiable. The Cordera™ Hip System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:

· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia.

· Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.

· Revision procedures for failed previous hip surgery (excluding situations where hardware is present).

The Cordera™ Hip System includes standard hip replacement components, and if selected, may use patient-specific single use instrumentation.

The Conformis Cordera Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

The Cordera Hip System is an uncemented, primary total hip replacement composed of femoral and acetabular components. The system can be used with or without a pre-operative CT scan that is used to design patient-specific instruments. All components are provided sterile.

The femoral component consists of a standard monoblock femoral stem body and neck, which mates with a standard femoral head. The stem and neck are manufactured as one piece and hence are not modular. The proximal neck surface with a 12/14 taper is highly polished and transitions to hydroxyapatite coating in the main stem body and is indicated for uncemented press fit fixation only. The femoral head is designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem. The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (Biolox® Delta).

The acetabular component consists of a standard size shell in 1mm increments with standard screw hole placement, a mating polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fit through the acetabular shell screw holes and are driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation. The liner is provided with an impactor made of a biocompatible nylon material.

The purpose of this submission is to add patient specific instruments (iJigs) and surgical plans (iViews) to the Cordera Hip System.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets those criteria, specifically concerning an AI/ML powered medical device.

The document is an FDA 510(k) clearance letter for the Cordera Hip System, which is a traditional medical device (hip replacement system), not an AI/ML enabled one.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document discusses the substantial equivalence of the Cordera Hip System to predicate devices based on its intended use, technological characteristics, materials, and manufacturing processes. It briefly mentions "patient specific iJigs" (instrumentation) which use CT scans for design, but this is a design specificity for a physical instrument, not an AI/ML algorithm that interprets or diagnoses from images.

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