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510(k) Data Aggregation
(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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