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The Radial Head Prosthesis is intended for replacement of the proximal end of the radius due to degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and/or proximal radio-ulnar joint involving joint destruction or subluxation visible on xray, resistance to conservative treatment; primary replacement after fracture of the radial head; and symptomatic sequelae after radial head resection.

The Radial Head Prosthesis, like the predicate devices, includes various sizes of implants to accommodate the requirements of patient anatomy.

This looks like a 510(k) summary for a medical device (Radial Head Prosthesis) submitted to the FDA. The provided text does not include information about acceptance criteria or a study proving the device meets those criteria.

Instead, the document focuses on:

• Device identification: Submitter, device name (K992220), classification, etc.
• Predicate devices: List of similar, legally marketed devices (Avanta Orthopaedics, Swanson Titanium, Implex).
• Device description: General information about the Radial Head Prosthesis.
• Intended use: Specific medical conditions for which the device is designed.
• Technological characteristics: Material (Cobalt-Chrome, ASTM F 90, ISO 5832-5).
• FDA correspondence: The letter from the FDA stating that the device is substantially equivalent to predicate devices.
• Indications for Use statement: A formal statement of the device's intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies, as this information is not present in the provided text.

To answer your questions, I would need a different document, typically a more detailed report or a specific section of the 510(k) submission that outlines performance testing and acceptance criteria. For devices like prostheses, this often involves:

• Mechanical Testing: Fatigue testing, static strength testing, wear testing.
• Biocompatibility Testing: Evaluating the material's interaction with the body.
• Clinical Data (if applicable): While not always required for 510(k) new devices based on predicate devices, sometimes clinical data is used to support substantial equivalence.

Without that specific information, I cannot fill out the requested table or answer the detailed questions about sample sizes, ground truth, expert qualifications, or MRMC studies.

Ask a specific question about this device