(247 days)
Use of the Mag View Biomagnetometer is indicated for the patient whose physician believes that information about the magnetic fields produced by that patient's brain and information about the sources of those magnetic fields could contribute to diagnosis or therapy planning. The intended patient populations are neonates and those children with head circumferences of 50 cm or less.
The Tristan Technologies MagView Biomagnetometer (hereinafter referred to as the "MagView") utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in brain. The MagView consists of a sensor unit, an electronics subsystem for preliminary amplification, filtering, and analog to digital conversion of the signals from each SOUID, an electronics rack containing power supplies to power the electronics subsystem, a computer to control the operation of the electronic subsystem and the SQUIDs and to acquire and store the signal values collected by the system.
This document is a 510(k) Premarket Notification from the FDA regarding the Tristan Technologies MagView Biomagnetometer. It does not contain information about a study proving the device meets acceptance criteria in the typical sense of a clinical trial with performance metrics like sensitivity, specificity, etc., as would be expected for an AI/CAD-driven device today.
Instead, this submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (Magnes 2500 WH Biomagnetometer System). This means the "acceptance criteria" and "study" are geared towards showing that the new device is as safe and effective as the predicate, based on technological characteristics and non-clinical testing.
Here's a breakdown of the requested information based on the provided text, and where gaps exist because the document is a 510(k) for substantial equivalence rather than a detailed performance study:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (MagView Biomagnetometer) |
|---|---|
| Technological Equivalence to Predicate: | Identical Technology: Utilizes superconducting signal pickup coils and SQUIDs to detect and amplify magnetic fields from brain activity. |
| - Method of operation | |
| - Sensitivity of pickup coils | - Sensitivity of each pickup coil: 10 femtoTesla/√Hz or better. (Matches predicate) |
| - Bandwidth | - Bandwidth: 1 Hz to 1 kHz. (Matches predicate) |
| - Noise cancellation capability | - Second pickup coil array for noise cancellation is available. (Matches predicate) |
| - Cryogenics and housing | - Uses liquid helium cryogenics; vacuum container with helmet-like external shape. (Matches predicate) |
| - SQUID output processing (voltage, digitization) | - Output voltage proportional to magnetic field. Digitized with 24-bit precision at 5 kHz sample rate. (Predicate: 16-bit, 2 kHz) (Considered an improvement/equivalent) |
| - Data storage | - Digitized signals conveyed to computer hard drive. (Matches predicate) |
| Intended Use Equivalence to Predicate: | Identical Intended Use: Information about magnetic fields from the brain and source localization for diagnosis/therapy planning in neonates and children with head circumference ≤ 50 cm. |
| Safety Standards Compliance: | Complies with: IEC 60601-1:1988 + A1:1991 + A2:1995, IEC 60601-1-2:2007, IEC 61000-4-series, CISPR 11: 2010. |
| Non-clinical Performance (Magnetic Signal Detection): | Measured Sensitivity: Averaged over all primary channels, 10 femtoTesla/√Hz or better, over a bandwidth of 1Hz to 1 kHz. (Comparable to predicate) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of human subjects or clinical data. The "test set" here refers to the device itself and its components undergoing non-clinical technical testing.
- Data Provenance: The testing was "non-clinical testing of the system" using "external calibrated signal sources." This implies laboratory-based, engineering validation rather than patient data. No country of origin for patient data is mentioned as no patient data was used for performance assessment in this submission. The testing appears to be "prospective" in the sense that the device was specifically tested to demonstrate its technical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth for non-clinical technical performance (like magnetic sensitivity) is established by calibrated measurement tools and engineering principles, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There is no human interpretation or decision-making process described that would require adjudication for this type of technical performance testing.
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
- MRMC Study: No. This document describes a biomagnetometer, which is a measurement device for brain activity. It is not an AI/CAD device, and therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The "non-clinical testing of the system" on its own demonstrates standalone technical performance (e.g., sensitivity, bandwidth) of the device components. There is no "algorithm" in the sense of an AI model being evaluated here. The device itself is the "standalone" entity being described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the non-clinical testing, the ground truth was provided by "external calibrated signal sources." This would involve known, precisely generated magnetic fields used to verify the device's measurement accuracy and sensitivity.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a biomagnetometer, not a machine learning or AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
Summary of the "Study" mentioned for meeting "Acceptance Criteria":
The "study" referenced in the document is the non-clinical performance testing of the MagView Biomagnetometer. This testing involved:
- Comparing the technological characteristics (method of operation, sensor sensitivity, bandwidth, cryogenics, output processing, etc.) of the MagView to those of the predicate device (Magnes 2500 WH).
- Conducting direct measurements on the MagView using "external calibrated signal sources" to verify its magnetic signal detection performance (specifically, its sensitivity and bandwidth).
- Ensuring compliance with relevant safety standards (IEC and CISPR).
The acceptance criteria were primarily defined by demonstrating that the MagView's technological characteristics and measured performance were either identical, equivalent, or improved compared to the predicate device, and that it met established safety standards. The conclusion was that the MagView is "as safe, as effective, and performs as well as the Magnes 2500 WH."
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).