(185 days)
BrainLAB VectorVision Spine Module is intended to be an intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's images data being processed by a BrainSCAN workstation (K915819). The system is indicated for any medical condition where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra can be identified relative to a C.I hased model of the anatomy where surgically appropriate.
intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's images data being processed by a BrainSCAN workstation (K915819).
This document is a 510(k) clearance letter for the BrainLAB VectorVision Spine system. It indicates FDA clearance for marketing but does not contain detailed information about acceptance criteria or specific study results that prove the device meets those criteria. Such information is typically found in the 510(k) summary or the full submission, which is not provided here.
Therefore,Based on the provided document (FDA 510(k) clearance letter for BrainLAB VectorVision Spine), the detailed information requested regarding acceptance criteria and a study proving device performance is not available.
This document is a regulatory approval letter, indicating that the device has been found substantially equivalent to a predicate device. It does not contain the technical details of performance studies or acceptance criteria that would typically be found in a 510(k) summary or the full submission.
Therefore, for each of your points, the answer is:
- A table of acceptance criteria and the reported device performance: Not provided in this document.
- Sample size used for the test set and the data provenance: Not provided in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in this document.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in this document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided in this document. The device is an image-guided localization system, not an AI-assisted diagnostic tool for human readers in the context of MRMC studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not provided in this document. The device is described as an "intraoperative image guided localization system to enable open or percutaneous surgery," which implies human interaction.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in this document.
- The sample size for the training set: Not provided in this document.
- How the ground truth for the training set was established: Not provided in this document.
To obtain this information, one would typically need to review the full 510(k) submission or the 510(k) summary if it were publicly available and detailed enough.
§ 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).