(134 days)
The BrainLAB Stereotactic Arc system is an isocentric/target centered stereotactic arc for the adjustment of instrument trajectories and holding of instruments for neurosurgical applications in x,y,z directions and in azimuthal and declination angles requiring coordinate-accurate imaging-guided target localization and instrument guidance.
BrainLAB Stereotactic Arc system is an isocentric/target centered stereotactic arc for the adjustment of instrument trajectories and holding of instruments for neurosurgical applications.
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "BrainLAB Stereotactic Arc," and it primarily focuses on the regulatory approval and substantial equivalence to a predicate device.
Specifically, the document does not include:
- A table of acceptance criteria or reported device performance.
- Information on sample sizes for test or training sets.
- Data provenance.
- Details about experts for ground truth or adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- The type of ground truth used.
- How ground truth was established for a training set.
The document states the device's indications for use, but does not elaborate on the specific performance metrics or studies conducted to demonstrate its efficacy or 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).