(130 days)
The "ZMM 2000 Zeppelin Millenium Motordrill System" is a fast running (~90.000 rpm) powered surgical drill system for the rapide trepanation of bone, plastic, metal or cement with high precision. It is in particular usefull to rapidly cut bone in neurosurgical, ENT, maxillofacial and orthopedic procedures.
The ZMM 2000 Zeppelin Millenium Motordrill System consists of a small handpiece motor, a motor air tube, a foot control, a wall air tube, various nosepieces and craniotoms and burs. The system components connect to each other via a proprietary coupling system.
The provided document is a 510(k) premarket notification summary for the ZMM 2000 Zeppelin Millennium Motordrill System. It outlines the device description, intended use, and substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.
The document states under section F. "PERFORMANCE STANDARDS" that: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Zeppelin's ZMM 2000 Zeppelin Millenium Motordrill Sytem is manufactured in accordance with ISO and German DIN Standards. Furthermore, the Zeppelin GmbH has received ISO 9001 certification."
This indicates that the device's acceptance criteria are based on compliance with manufacturing standards (ISO, DIN, ISO 9001 certification) rather than specific performance benchmarks demonstrated through a clinical or technical study designed to prove efficacy or safety metrics against predefined criteria.
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies because this information is not present in the provided 510(k) summary. The submission focuses on demonstrating substantial equivalence to predicate devices (Zeppelin Motordrill System #K922299, Aesculap HiLan Motor System for Neurosurgery #K980686, Midas Rex, Midas Rex I, II #K950518, Komet Medical Xk -95 Perforator Motor #991625, Black Max by Anspach) rather than presenting a performance study against specific acceptance criteria.
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).