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Indications for use in total hip replacement include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

The modification to the system consists of a change in the method or porous coating of the acetabular shells from a two layer process to a three layer process utilizing a smaller bead size and smaller pore size.

The provided text is a 510(k) summary and FDA clearance letter for a medical device (FMP Metal/Metal Acetabular Insert). It does not contain any information regarding acceptance criteria, device performance metrics, study design, or any of the detailed questions you've asked about a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Identification of the device: FMP Metal/Metal Acetabular Insert.
• Manufacturer and contact information.
• Classification and regulation details.
• Description of the modification: A change in the porous coating process of the acetabular shells.
• Intended Use and Indications for Use.
• Comparison to predicate devices: Stating that features are comparable in terms of materials, design, indications, packaging, labeling, and sterilization.
• FDA's Substantial Equivalence determination.

Therefore, I cannot provide the requested information such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, or clinical study details because these are not present in the provided text.

This type of submission (510(k)) typically aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than providing new clinical study data with detailed performance metrics and acceptance criteria as would be found in a PMA (Premarket Approval) submission or a comprehensive clinical trial report. The "study" mentioned here is primarily a comparison to the predicate, focusing on the equivalence of the modified component, not typically a performance study against predefined numerical acceptance criteria in the manner you've described.

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