(125 days)
The 7D Surgical System Percutaneous Application is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.
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I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a medical device (7D Surgical System Percutaneous Application), outlining that the device has been found substantially equivalent to a predicate device and is cleared for marketing.
It mentions the device's indications for use but does not include details on performance metrics, study design, sample sizes, ground truth establishment, or expert qualifications that would be needed to answer your questions.
§ 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).