(26 days)
The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. It may be used in open or minimally invasive or percutaneous procedures.
Mazor X 3D imaging capabilities provide a procession of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.
The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.
The Mazor X system combines robotic trajectory guidance with navigated surgical instruments (either guided or free hand navigation) to enable the surgeon to precisely position surgical instruments and/or implants according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. The modified Mazor X, the subject of this 510(k) application, introduces software and hardware modifications to the original Mazor X System cleared in 510(k) K200935.
The provided text is a 510(k) premarket notification for the Mazor X system, which outlines the device's indications for use and states that the current submission is for software and minor hardware modifications to a previously cleared device (K200935).
It does not contain a detailed study proving the device meets specific acceptance criteria in the typical sense of a clinical trial. Instead, it focuses on verifying that the modifications to the already cleared device do not adversely affect its safety, effectiveness, and performance. The performance testing described is primarily focused on software validation and ensuring that the modifications did not degrade previously established accuracy metrics.
Therefore, many of the requested details, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, etc., are not applicable or not provided in the given document for the current submission. The document refers to these metrics as previously established for the predicate device.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is not available:
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Table of acceptance criteria and reported device performance:
Acceptance Criteria (from predicate validation) Reported Device Performance (after modifications) Robotic guidance trajectory accuracy:
§ 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).