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The Maestro™ Total Wrist System 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 distal radius and/or carpal bones.

The radial and carpal components are intended to be implanted with bone cement.

The Maestro™ Wrist Fracture Replacement System consists of a two piece radial component and a molded carpal bearing component for total wrist replacement. The radial component is composed of a distal body with a modular stem. The distal bodies have a highly polished bearing surface located anatomically. The Maestro™ Tapered Carpal Component is composed of three subcomponents - a carpal head, a carpal plate and a capitate stem. The carpal head is composed of polyethylene molded on to a metallic base. The carpal plate has a male taper which mates with a female taper in the carpal head. The plate features threaded screw holes that mate with the heads of spherical locking screws. Screws are available with both fixed and variable heads. The variable screws allow the surgeon to angle the screws upon insertion while still locking the screws to the plate. The capitate stem then screws into internal threads on the reverse side of the taper on the carpal plate to complete the implant.

The provided text is a 510(k) Summary for a medical device called the Maestro™ Wrist Fracture Implant. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

Because no clinical testing was performed or provided, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria. The information requested in your prompt (e.g., sample size, ground truth, expert qualifications, MRMC study, standalone performance, training set details) is typically found in clinical study reports, which are absent in this submission.

The document only mentions "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." However, it does not provide details on the specific acceptance criteria for this non-clinical testing or the results themselves in a structured format.

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