(56 days)
The ANSER Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
The ANSER Clavicle Pin is a device intended to be used for intramedullary fixation of mid-shaft clavicle fractures. The device consists of three parts. The main component is a nail, that is placed within the medullary canal of the fractured clavicle. It has a threaded medial end for fixation into the bone. At the lateral end an endcap is placed after insertion for lateral fixation of the pin. In this way the pin is secured both medially and laterally.
The provided text describes a 510(k) premarket notification for a medical device (ANSER Clavicle Pin), but it does not contain information about acceptance criteria for AI/ML performance, nor a study proving a device meets such criteria.
The document is a traditional 510(k) summary for an intramedullary fixation rod (ANSER Clavicle Pin) used to repair clavicle fractures. The "performance data" section specifically states:
"Results demonstrate equivalent mechanical performance as the predicate devices. No clinical data is presented."
This 510(k) is for a physical medical device (a pin) and the performance data presented is entirely based on preclinical mechanical testing (e.g., ASTM standards for bending and torsion testing) to demonstrate substantial equivalence to predicate physical devices.
Therefore, I cannot extract the information required to populate the requested table regarding acceptance criteria for AI/ML performance or details of a study proving a device meets such criteria, as this information is not present in the provided text.
§ 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.