(126 days)
The Orthopilot® Next Generation Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endoprosthesis replacement surgery(such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurements of bone alignment. It indicates angles and positions for implant placement.
Aesculap's OrthoPilot Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide optimal anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), power supply, various tagged instruments, an ultrasound module, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or mobile to palpate anatomical landmarks in conjunction with a camera to monitor the spatial location of the transmitters in relation to each other and/or instruments. The computer also can accept spatial input for anatomical landmarks from an ultrasound unit.
The provided text is a 510(k) summary for the Aesculap Orthopilot Next Generation, a surgical navigation platform. It states that "No applicable performance standards have been promulgated under FDCA Section 514 for this system" and that "The previously cleared software modules were developed in accordance with Aesculap's internal SOP's as well as CDRH's 'General Principles of Software Validation, Final Guidance for Industry and FDA Staff.'"
Therefore, the document does not contain the information requested regarding specific acceptance criteria, a study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details on ground truth for training or test sets.
The submission focuses on establishing substantial equivalence to a previously cleared device (Orthopilot Total Knee Arthroscopy software module, K080547) rather than providing detailed performance study data for the Orthopilot Next Generation.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).