(86 days)
The Tibia OrthoNail is indicated for stabilizing tibral fractures.
The Tibia OrthoNail is a solid cylinder. The Tibia OrthoNail is available in diameters, 9 - 14 mm and in lengths of 200 - 425 mm. The device is designed to accept transfixing screws. End caps are provided. For use during insertion an Impacting Anvil is provided. An Alignment Tower is provided to ensure proper alignment of transfixation screw holes. The Anvil has an internal proximal thread for attachment of a slaphammer that is used for insertion or distraction.
This document is a 510(k) premarket submission for a medical device (Tibia OrthoNail), not a study evaluating the performance of an AI/ML device. Therefore, it does not contain information related to acceptance criteria or studies proving device performance in the context of AI/ML.
The provided text describes the device, its classification, and makes a claim of substantial equivalence to predicate devices based on technological characteristics (materials, dimensions, design features), but it does not include:
- Acceptance criteria for AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
- Any study details, sample sizes, ground truth establishment, or expert involvement relevant to AI/ML device evaluation.
- Information about training sets, test sets, or comparative effectiveness studies involving AI assistance.
Essentially, the document focuses on regulatory approval for a physical medical implant, not the assessment of an intelligent algorithm.
§ 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.