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The Maestro™ Carpal HemiArthroplasty is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis
2. Rheumatoid arthritis
3. Revision where other devices or treatments have failed
4. Scapholunate Advanced Collapse (SLAC) and other functional deformities
5. Trauma, including fractures of the carpal bones
   The device is intended to be implanted with bone cement.

The Maestro™ Carpal HemiArthroplasty is a three piece carpal component designed to articulate with the natural radial bone. The carpal component consists of 3 sub-components - a carpal head, a carpal plate and a capitate stem. The carpal head comes in 3 heights, standard, +2 and +4. This allows the surgeon to adjust for soft tissue laxity. Two lengths of carpal plates give the surgeon options of screw placement.

The provided text does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary for the Maestro™ Carpal HemiArthroplasty. It states:

• Non-Clinical Testing: "Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions." However, no specific acceptance criteria, performance metrics, or study details (like sample size, methodology, or results) are provided.
• Clinical Testing: The document explicitly states: "None provided."

Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness. The information is simply not present in the provided text.

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