(276 days)
Acute traumatic fracture of the proximal radius not suitable for internal fixation. Unstable elbow following radial head resection, including wrist pain following radial head resection after radio-cubital dislocation or impingement of the carpus.
The Tornier® Bipolar Radial Head Prosthesis developed by Tornier combines modern materials, proven design concepts, and established operative techniques to produce an evolutionary advance in radial head implant replacement of the elbow. The design is bipolar in nature, possessing two separate articulation surfaces. Movement can occur between either or both articulating surfaces. The device is made up of three parts: the stem, the metal head, and the polyethylene press-fit insert. The stems and metal head are made from iron-cobalt-chrome (FeCrCo) steel meeting international standard ISO 5832-7 (Feb94). The UHMWPE head meets ISO 5834-2 (Nov 186). Specialized instruments are required for implantation.
The provided text describes a medical device, the Tornier® Bipolar Radial Head Prosthesis, and its 510(k) premarket notification to the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document primarily focuses on:
- Regulatory information: Device name, classification, special controls, predicate devices, and the FDA's 510(k) clearance letter.
- Device description: Design (bipolar nature), materials (FeCrCo and UHMWPE), and components.
- Manufacturing and Sterilization: Manufacturing facility, sterilization method (gamma radiation), and instrument sterilization.
- Indications for Use: Acute traumatic fracture of the proximal radius, and unstable elbow following radial head resection.
Therefore, I cannot provide the requested table and study details as the information is not present in the provided text.
The text explicitly states under "13. Performance Data": "Biomechanical and clinical data establish the equivalence of the design when contrasted with the indicated comparison devices." However, it does not provide any details about this data, such as acceptance criteria, specific performance metrics, study design, sample sizes, or ground truth methods.
§ 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.