(73 days)
The Osteo I-C Humeral Nail System is indicated for single-use in the humeral shaft to address the following indications: fractures of the humeral shaft, non-unions, malalignments, pathologic fractures, and impending pathologic fractures.
The use of the Osteo I-C humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures. The use of this system is indicated for diagonal and short oblique fractures of the humeral diaphysis as well as fractures of the metaphyseal and some comminuted humeral fractures. The Osteo I-C Humeral Nail System is intended for single use only.
Indications:
- Fractures of the humeral shaft
- Non-unions
- Malalignments
- Pathologic humeral fractures
- Impending pathologic humeral fractures
The Osteo I-C Humeral Nail System consist of the Osteo I-C Humeral Nail, a cylindrical tube which is intended to aid in the alignment and stabilization of humeral fractures and associated components include the Osteo I-C Humeral Nail Locking Screw, the Osteo I-C Humeral Nail Compression Screw and the Osteo I-C Nail Humerus Protection Screw which are intended to secure the Osteo I-C Humeral Nail in place.
The provided text is a summary of a 510(k) Premarket Notification for the Osteo I-C Humeral Nail System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in the prompt regarding a study proving the device meets acceptance criteria.
The document explicitly states:
"The comparison of the Osteo I-C Humeral Nail System to predicate systems which have been determined to be substantially equivalent through 510(k) premarket notifications demonstrates that no additional performance data are necessary."
This indicates that the device's approval was based on demonstrating substantial equivalence to already approved predicate devices, rather than conducting new performance studies against defined acceptance criteria. Therefore, I cannot extract the requested information from this document.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.