(27 days)
The Radionics OTS with Passive-Reflective Tracking Configuration is indicated for use in cranial and spinal surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.
This premarket notification describes a modification to the Radionics Optical Tracking System (OTS). The common name of this device is Intraoperative Guidance Device, and its classification name is Stereotaxic instrument. The modification involves the use of a NDI Polaris Camera and the incorporation of reflective spheres to the Standard Probe, Depth Probe, UIR, Microscope Frame, and DRF accessories. These accessories are substantially equivalent to their wired counterparts in the predicate Radionics OTS. When coupled with the OTS workstation and using the NDI Polaris Camera, the above reflective accessories function in the same way as the predicate wired versions by allowing preoperative and operative planning of cranial and spinal surgical procedures using workstation images.
The provided text is a 510(k) summary for a modification to the Radionics Optical Tracking System (OTS). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor does it include specifics about sample sizes, expert qualifications, or ground truth establishment relevant to performance metrics.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and device performance from the provided text.
The document primarily focuses on the regulatory submission process, stating that the modification involves using a NDI Polaris Camera and incorporating reflective spheres, and that these accessories function in the same way as their wired counterparts. It confirms substantial equivalence but does not detail performance data, clinical trials, or validation studies in the way you've outlined.
§ 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).