(70 days)
Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:
- Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray .
- resistance to conservative treatment .
- Primary replacement after fracture of the radial head .
- Symptomatic sequelae after radial head resection .
The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.
This appears to be a 510(k) premarket notification for a medical device (radial head implant), not a study analyzing the performance of a device or an AI algorithm. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not present in the provided text.
The document is a regulatory submission demonstrating substantial equivalence to a predicate device, focusing on design characteristics and intended use, rather than a clinical or performance study report.
If you have a document that describes a study on a device's performance, I can analyze it for the requested information.
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.