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510(k) Data Aggregation
(21 days)
NEUROMAG VECTORVIEW
The Neuromag Vectorview system is intended for use as a magneto encephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.
This device integrates 306 sensor elements, including planar gradiometers and magnetometers, with medical super-computers and data acquisition software in order to measure the differences in the magnetic signals generated by the intracellular dendritic currents. These detectors are positioned in a helmet shaped array that gives the user the ability to record the electrical activity of the entire surface of the brain simultaneously without having to move the position of the probe.
Here's an analysis of the provided text regarding the Neuromag Vectorview device, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a 510(k) submission for the Neuromag Vectorview, which asserts substantial equivalence to a predicate device, the Neuromag-122 (K962764). In such submissions, the "acceptance criteria" are not explicitly defined as pass/fail thresholds for specific performance metrics in the way one might see in a clinical trial. Instead, the acceptance criterion is met if the new device (Vectorview) is demonstrated to be substantially equivalent to the predicate device (Neuromag-122) in terms of safety and effectiveness.
The "study" conducted to prove this involves a direct comparison of the technical specifications and intended use of the Neuromag Vectorview against the legally marketed predicate device, Neuromag-122. The reported device performance is presented as a side-by-side comparison of features, rather than quantitative performance data from a clinical study.
| Parameter | Acceptance Criteria (Substantially Equivalent to Predicate) | Reported Device Performance (Neuromag Vectorview) |
|---|---|---|
| Safety and Effectiveness (Overall) | Must be substantially equivalent in safety and effectiveness to Neuromag-122. | Stated as "substantially equivalent to the Neuromag-122 in safety and effectiveness." |
| Intended Use & Indications for Use | Same as Neuromag-122. | "The Neuromag Vectorview system does not change the existing intended use and indications for use for the Neuromag-122..." and listed identically. |
| Number of SQUID Sensor Elements | No explicit 'criteria', but compared to predicate. | 102 (Predicate: 61) |
| Number of Channels for MEG Data | No explicit 'criteria', but compared to predicate. | 306 (Predicate: 122) |
| Number of Auxiliary Channels | No explicit 'criteria', but compared to predicate. | 144 (typically 64 for EEG) (Predicate: 134, typically 32 for EEG) |
| Coil Configuration | No explicit 'criteria', but compared to predicate. | Two orthogonal planar-first-order gradiometers and one magnetometer per location (Predicate: Two orthogonal planar-first-order gradiometers per location) |
| Intersensor Spacing | No explicit 'criteria', but compared to predicate. | 34-35 mm (Predicate: 43-44 mm) |
| Sensor Element Placement / Geometry | No explicit 'criteria', but compared to predicate. | 102 locations distributed across helmet-shaped lower tip of dewar, shape based on anatomy (standard EN960:1994). Inside dimensions 222 mm (length) x 181 mm (width) x 209 mm (depth). |
| Cryogen Used | Same as Neuromag-122. | "Same." (Predicate: Liquid Helium) |
| Coverage | Same as Neuromag-122. | "Same." (Predicate: One acquisition to cover entire head) |
| Gantry | No explicit 'criteria', but compared to predicate. | Floor mounted. Dewar helmet is either tilted 30° for seated position or horizontal (180°) for supine position. (Predicate: Floor mounted, standard gantry tilts up to 30°. Optional gantry tilts to 45°.) |
| Patient Position | Same as Neuromag-122. | "Same." (Predicate: Seated or Supine. Optional chair insert for children.) |
| Head Position Indicator | Same as Neuromag-122. | "Same." (Predicate: Available) |
| Computer | Same as Neuromag-122. | "Same." (Predicate: Hewlett Packard workstation with UNIX environment.) |
| Networking Capabilities | Same as Neuromag-122. | "Same." (Predicate: Ethernet connections to other workstations available) |
| Software | Same as Neuromag-122. | "Same." (Predicate: Data Acquisition, Display plotting and Signal processor for continuous data.) |
| Magnetic Shielded Room Accessories | Same as Neuromag-122. | "Same." (Predicate: Video monitor and two-way intercom for monitoring patients.) |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of a clinical performance study with patient data. This is a 510(k) submission based on substantial equivalence, not a clinical trial. The comparison is against the specifications of a predicate device. Therefore, no patient sample size or data provenance (country of origin, retrospective/prospective) is provided for a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no test set of patient data requiring expert ground truth establishment. The "ground truth" here is the prior FDA clearance of the predicate device (Neuromag-122) and its established safety and effectiveness.
4. Adjudication method for the test set
Not applicable. There is no test set of patient data requiring adjudication.
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
Not applicable. This is not a study involving AI or human reader performance. It is a comparison of hardware and basic software specifications to demonstrate substantial equivalence to a predecessor device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm that performs a diagnostic task in a standalone manner. It is a medical device for acquiring biomagnetic signals, which are then interpreted by a trained clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the regulatory status and established safety/effectiveness profile of the predicate device (Neuromag-122), which was previously cleared by the FDA (K962764). The new device (Vectorview) claims substantial equivalence to this established "ground truth" through a comparison of physical and functional specifications.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/algorithm-based device undergoing a machine learning training process.
9. How the ground truth for the training set was established
Not applicable. As there's no training set, there's no ground truth established for it.
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