(126 days)
The BioPoly Radial Head Implant is indicated for:
- · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain. crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
- o joint destruction and/or subluxation visible on x-ray; and/or
- o resistance to conservative treatment
- · Primary replacement after fracture of the radial head
- · Symptomatic sequelae after radial head resection
- · Revision following failed radial head arthroplasty
The BioPoly Radial Head Implant is a hemiarthroplasty device designed to restore the articular surface and spacing of the proximal head of the radius in patients following fracture resection and/or degenerative disability The implant is supplied with head diameters of 20mm, 23mm, and 26mm; and stem diameters of 6mm, 7mm, 8mm, +3mm, and +6mm height offsets for the radius in patients following fracture, resection, and/or degenerative disability.
This document is a 510(k) Premarket Notification from the FDA regarding the BioPoly Radial Head Implant. It certifies the device's substantial equivalence to previously marketed predicate devices. The document outlines the device's intended use and provides a summary of non-clinical tests conducted.
However, the provided text does not contain any information about a study proving the device meets acceptance criteria through human-in-the-loop performance, nor does it refer to an AI/ML powered device. The acceptance criteria discussed are for non-clinical, mechanical, and material properties of the implant itself, not related to an AI's performance or a clinical study that would involve the elements requested in the prompt (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance of an algorithm).
Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and related clinical study design (sample size, expert adjudication, MRMC, etc.). The document focuses on the mechanical and material aspects of a physical implant and its substantial equivalence to predicate devices, which is a different regulatory pathway than for AI/ML-powered medical devices.
§ 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.