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510(k) Data Aggregation
(28 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. The V-TAG can be manipulated to provide a wide range of surgical trajectories into the head. An image-quided 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. Adjustment of the V-TAG may be performed in the MRI scanner to refine or change the trajectory based on updated intraoperative imaging. 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 text describes a 510(k) premarket notification for the V-TAG (Voyager Trajectory Array Guide) device, a modification to a previously cleared predicate device (K180854). The core purpose of this submission is to modify the instructions for use to allow for trajectory adjustments in the MRI scanner based on intraoperative imaging.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| X, Y, Z errors ≤ 2.0mm | All placements met the acceptance criteria. |
| Angular error of ≤ 2° | All placements met the acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states, "For each trial, the beginning alignment was intentionally set to an error greater than 10mm." It does not explicitly state the total number of "trials" or "placements" conducted. It implies multiple trials but lacks a specific numerical count for the test set.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective. Given the context of a 510(k) summary for a medical device, it is highly likely to be prospective testing specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The testing described appears to be a technical accuracy assessment (measuring alignment deviations) rather than an expert-adjudicated clinical outcome study.
4. Adjudication Method for the Test Set:
- This information is not provided and is not applicable in the context of the described technical accuracy testing. There's no indication of human expert adjudication for the "ground truth" errors, as the errors were likely directly measured against the planned trajectory.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- An MRMC comparative effectiveness study was not conducted. This device is a surgical guidance tool, not an AI-assisted diagnostic or interpretation system that would typically warrant such a study. The study focuses on the device's physical accuracy in guiding instruments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not directly applicable as the V-TAG is a physical surgical guidance device, not primarily an algorithm or software that operates in a "standalone" fashion. While it works in conjunction with an image-guided neuronavigational system, the performance evaluation here is on the V-TAG's physical accuracy when manipulated by a human in a simulated or real surgical setting, confirmed by imaging. The "algorithm only" concept usually applies to diagnostic interpretations or automated decision-making.
7. The Type of Ground Truth Used:
- The ground truth for the accuracy testing appears to be the pre-planned trajectory of the center lumen to the target. The "projected errors were then calculated," implying a measurement of deviation from this intended target.
8. The Sample Size for the Training Set:
- This information is not applicable as the described study is a performance validation of a physical device's mechanical accuracy, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable as there is no training set mentioned or implied for this type of device validation.
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(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 <2 (mild reactivity). | Non-cytotoxic. No evidence of cell lysis or toxicity. Grade <2 (mild reactivity). |
| Intracutaneous Toxicity | No biological response elicited; no adverse observations throughout the test duration; overall mean score of 0.0 for sodium chloride and sesame oil test article extracts. | No biological response elicited. No adverse observations noted throughout the duration of the test. Overall mean score was 0.0 for both the sodium chloride and sesame oil test article extracts. | |
| Systemic Toxicity: ISO Acute Systemic Injection Test | Study requirements met; no biological response elicited; no mortality nor evidence of systemic toxicity. | Study requirements met. No biological response elicited. No mortality nor evidence of systemic toxicity. | |
| Sensitization | Non-sensitizing; no evidence of causing delayed dermal contact sensitization. | Non-sensitizing. Test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. | |
| Material Mediated Pyrogenicity | Deemed non-pyrogenic; no animal experienced a temperature rise of 0.5°C or more above its baseline. | Test article deemed non-pyrogenic. No animal experienced a temperature rise 0.5°C or more above its baseline. | |
| Bench Performance | MRI Compatibility | Components intended for MR environment (V-TAG Base, Guide, Imaging Cartridge, and Reducer) should be MR safe. | V-TAG Base, Guide, Imaging Cartridge, and Reducer are MR safe. |
| Integrity Testing - Zero time and 1-year accelerated | Predetermined test specifications were met for all evaluated parameters (dimensional verification, device stability, seal integrity of Image Cartridge, bond and joint strength for Image Cartridge, Reducer Handle and tip) at both time points. | Predetermined test specifications were met for all tests at both time points. |
Since this is a mechanical device, the following points are not applicable (N/A) in the context of this 510(k) submission, as they relate to AI/algorithm performance studies:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. The testing was non-clinical bench testing, not a data-driven algorithm evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Ground truth for an AI algorithm is not relevant for this mechanical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not an AI algorithm performance study.
5. 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
- N/A. Not an AI assistance device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. For this device, "ground truth" relates to physical properties and material safety, established by standardized test methods (ISO, ASTM, USP) and laboratory findings, not clinical "truth" points for algorithms.
8. The sample size for the training set
- N/A. No training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- N/A. No training set.
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