(62 days)
The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures. This includes use in frameless cranial biopsy procedures.
The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures.
The provided document is a 510(k) summary for a medical device (Radionics Optical Tracking System - OTS) and its FDA clearance letter. It does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
The document discusses:
- The device name and its classification.
- Its substantial equivalence to predicate devices.
- Revised indications for use (specifically for frameless cranial biopsy).
- General information about its function as a graphical planning and intraoperative navigation tool for cranial and spinal surgical procedures.
- The FDA's confirmation of market clearance.
Therefore, I cannot provide the requested table and study details based on the given information. The information needed to answer the prompt (acceptance criteria, study design, performance results, ground truth, sample sizes, expert qualifications, etc.) is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) summary.
§ 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).