(46 days)
Aesculap's Craniocut is intended for use in cutting bone in craniotomies.
Aesculap's Craniocut is an oscillating hollow saw. It consists of the Craniocut handpiece with adjustable depth stop and the disposable trephine. The Craniocut is to be operated at maximum 20,000 rpm and can be connected to Aesculap power systems like the Microspeed EC or HiLan Motor Systems.
The provided document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding algorithm performance or expert review processes.
This 510(k) submission for the Aesculap Craniocut is a premarket notification for a medical device (a cranial trephine) that cuts bone in craniotomies. The submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a detailed performance study with acceptance criteria in the context of an automated or AI-driven system.
Therefore, I cannot populate the requested tables and information. The document explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This indicates that the regulatory pathway for this device at the time did not require the kind of detailed performance study you're asking for, which is common for AI/ML-based medical devices today.
If you have a document describing a digital health device or AI/ML algorithm, I would be able to extract that information.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).