(208 days)
The AOS Clavicle Intramedullary Device is intended to be used to repair an acute fracture, mal-union, or non-union of the Clavicle.
The system consists of an intramedullary titanium device and a fully threaded 2.7mm cortical screw for Clavicle fracture fixation.
The provided document is a 510(k) summary for the AOS Clavicle Intramedullary Device. It describes the device, its indications for use, and its substantial equivalence to predicate devices based on preclinical testing.
However, the document does not contain any information about acceptance criteria, device performance metrics, or a study involving human readers or AI algorithms. The "preclinical testing" mentioned is mechanical testing (a four-point bend test) and is used to demonstrate substantial equivalence to a predicate device, not to assess performance against specific clinical acceptance criteria.
Therefore, for the information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details, the answer is:
- No information is available in the provided document for these specific requests.
The document is primarily a regulatory submission demonstrating the device's substantial equivalence for market clearance, not a clinical study report with performance metrics for diagnosis or treatment outcomes, nor does it involve any AI component.
§ 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.