(68 days)
The SNT Stereotactic Localization System is indicated for providing a precise stereotactic coordinate system in either CT or Radiographic images for the purpose of planning and performing stereotactic cranial procedures.
The system includes:
- a headring .
- a CT localizer ●
- an X-ray localizer ●
- a film holder ●
This document, K971675, is a summary of safety and effectiveness for the SNT Stereotactic Localization System, a medical device cleared by the FDA in 1997. Due to the age and nature of the document (a 510k summary for a device without integrated AI), it does not contain the detailed information required for a modern AI-powered medical device submission's acceptance criteria and study design.
Specifically, the document is a 510(k) Pre-market Notification for substantial equivalence to devices marketed prior to May 28, 1976. This type of clearance primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing rigorous clinical trial data or performance metrics in the way an AI/ML device would be evaluated today.
Therefore, it is not possible to extract the requested information regarding acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set sizes from the provided text.
The document only states: "The SNT Stereotactic Localization System was shown to be substantially equivalent to other commercially available stereotactic localization systems." This is the core "acceptance criteria" for a 510(k) submission of this type at that time. There is no performance metric, only substantial equivalence.
In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria and study data in the context of an AI-powered medical device.
§ 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).