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The device is intended for use with a cemented femoral stem. The device is intended for use in hip arthroplasty applications whose indications include:

• Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic arthritis, protrusion acetabuli and painful hip dysplasia.
• Previously failed surgery.
• Proximal femoral neck fractures or dislocation.
• Idiopathic avascular necrosis of the femoral head.
• Non-union of proximal femoral neck fractures.
• Treatment of fractures that are unmanageable using other forms of therapy.
• Benign or malignant bone turnors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Ortho Development Ceramic Femoral Heads

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for Ortho Development Ceramic Femoral Heads, which details the regulatory approval process and the indications for use of the device. It does not include performance data, study designs, sample sizes, or information about ground truth establishment.

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The device is intended for use with an uncemented press-fit femoral stem. The device is intended for use in hip arthroplasty applications whose indications include:

• 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic arthritis, protrusion acetabuli and painful hip dysplasia.
• 2. Previously failed surgery.
• Proximal femoral neck fractures or dislocation. 3.
• 4. Idiopathic avascular necrosis of the femoral head.
• 5. Non-union of proximal femoral neck fractures.
• 6. Treatment of fractures that are unmanageable using other forms of therapy.
• 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Ortho Development Ceramic Femoral Heads with Press-fit Stems." It is not a study report that describes acceptance criteria and device performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness. The document only confirms that the device has been found substantially equivalent to legally marketed predicate devices and lists its intended indications for use.

To answer your questions, I would need a different type of document, such as a clinical study report, a scientific paper describing the device's performance, or a detailed regulatory submission document that outlines testing and validation.

Ask a specific question about this device