(112 days)
The V-TAG is intended to assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and perioperative MR imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode placement procedures.
The V-TAG™ device is a single-use, skull-mounted, rigid trajectory array guide used in stereotactic surgical procedures in adults. The V-TAG can be manipulated to provide a wide range of surgical trajectories into the head. An image-guided neuronavigational system loaded with a stereotactic surgical plan is used to align the V-TAG to the planned trajectory; once aligned, the V-TAG is securely locked to provide a stable instrument guide. After positioning of the V-TAG, magnetic resonance imaging (MRI) is used to confirm alignment with the planned trajectory. Intracranial placement of a neurosurgical device or surgical instrument using the V-TAG device is only to be performed after MRI confirmation of the trajectory.
The provided document is a 510(k) summary for the Voyager Trajectory Array Guide (V-TAG). It details the device's description, indications for use, technological characteristics, and non-clinical test results to demonstrate substantial equivalence to a predicate device.
Based on the provided document, here's a breakdown regarding acceptance criteria and the study that proves the device meets them:
The document focuses on demonstrating substantial equivalence to a predicate device (Monteris UFO, K090240) rather than meeting specific performance metrics for an AI/algorithm-driven device. The V-TAG is a physical, mechanical stereotactic guidance device, not an AI-powered diagnostic or assistive tool in the typical sense that would involve a "test set," "training set," "ground truth experts," or an "MRMC study."
Therefore, many of the requested points regarding AI/algorithm performance (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to this device's regulatory submission and the information provided.
The acceptance criteria here are primarily about safety and performance equivalence to a known, legally marketed device as demonstrated through non-clinical (bench) testing and biocompatibility assessments.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the "Conclusion" stated for each test, indicating that the device met the requirements to demonstrate substantial equivalence. The "reported device performance" is the outcome of these tests.
| Test Category | Specific Test | Acceptance Criteria (Implied by Conclusion) | Reported Device Performance (Conclusion) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity: 1X MEM Elution | Non-cytotoxic, no evidence of cell lysis or toxicity, Grade |
§ 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).