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The KMTI Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.

The Initia T3 Acetabular Hemispherical Shell System is intended for cementless applications.

The Kyocera Medical Technologies, Inc. (KMTI) Initia T3 Acetabular Hemispherical Shell System is a cementless shell intended for use in the treatment of hip disorders requiring hip replacement surgery. The Initia T3 Acetabular Hemispherical Shell System includes several components including: Initia T3 Acetabular Hemispherical Shell, Initia Acetabular Liner, Initia Bone Screw, and Delta 22.2 Femoral Head.

The Initia T3 Acetabular Hemispherical Shell is a cementless porous shell manufactured from Ti-6Al-4V ELI per ASTM F136. The Initia Acetabular Liner attaches to the inner surface of the Initia T3 Acetabular Hemispherical Shell and is available in four different configurations. The Initia Acetabular Liner is used to provide a single articulation implant option and is manufactured from Vitamin E infused UHMWPE per ASTM F2695 or UHMWPE per ASTM F648. The femoral head is manufactured from Biolox® delta and is available in two offsets.

This document clears the Initia T3 Acetabular Hemispherical Shell System for marketing. However, the provided text does not contain acceptance criteria or detailed study results in the manner requested for AI/software devices.

This FDA 510(k) clearance is for a physical medical device (an orthopedic implant), not an AI-powered diagnostic or assistive tool. The "performance data" section details various mechanical and material tests conducted on the implant itself to ensure its structural integrity, durability, and biological compatibility. It does not involve "test sets," "ground truth," "expert adjudication," or "multi-reader multi-case studies" in the context of evaluating an AI algorithm's diagnostic performance.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I provide information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These concepts are not applicable to the type of device described in the provided text.

The "performance data" described in the document relates to non-clinical (laboratory/mechanical) testing of the physical components of the hip replacement system.

If you intended to provide a different document related to an AI/software medical device, please provide that document.

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