MAGNES II BIOMAGNETOMETER by BIOMAGNETIC TECHNOLOGIES, INC.

The Magnes II Biomagnetometer is intenced for use in diagnostic procedures that require the measurement and display of extracranial magnetic fields and information about the electrical activity of the brain as inferred from those fields.

Device Description

The Magnes II Biomagnetometer system utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in the brain. The signals are amplified, filtered and digitized by signal processing electronics. The digitized signals are computer processed to produce displays of information about biomagnetic field strength, direction, and location.

The Magnes II Biomagnetometer system consists of: Two sensor units, one ganty mounted and one floor mounted, which house the superconducting components which are cooled to liquid helium winperature, an electronics subsystem for preliminary analog signal amplification, filtering, and analog-to-digital conversion, a computer subsystem "master analysis processor" to store, process, and display the data, a magnetically shielded room for interference reduction, a patient table for subject/patient support, and a gantry for articulation of the upper sensor.

AI/ML Overview

The provided text describes a 510(k) summary for the Magnes II Biomagnetometer. However, it does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, or the other specific information requested in your prompt (such as sample size, expert qualifications, adjudication methods, MRMC studies, training set details, etc.).

The document focuses on:

Device Description: How the Magnes II works (using SQUIDs to detect brain magnetic fields).
Intended Use: For diagnostic procedures requiring measurement and display of extracranial magnetic fields related to brain electrical activity.
Technological Characteristics: Emphasizes the addition of a second magnetic field sensor unit compared to the original Magnes system, and the distinction from EEG in using superconducting magnetic field sensors.
Nonclinical Tests and Results: Mentions "verification of basic physical principles" using "phantom" signal sources for localization accuracy, signal sensitivity, and background noise. It also states that tests comparing the second sensor to the original showed "no significant difference in the performance."
Conclusions: The second sensor provides increased coverage and reduced recording time.

Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text. The text does not provide the level of detail regarding device performance, study design, or ground truth establishment that you are asking for.

Here's a breakdown of what could be inferred vs. what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Localization Accuracy	Implied criterion: Must accurately localize phantom signal sources.
Signal Sensitivity	Implied criterion: Must detect biomagnetic signals with sufficient sensitivity.
System Background Noise	Implied criterion: Background noise should be acceptable relative to biomagnetic signals.
Equivalence of Second Sensor	Criterion: Performance of the second sensor should be equivalent to the original sensor.

2. Sample size used for the test set and the data provenance

Sample Size: Not mentioned. The tests were "nonclinical" and involved "phantom" signal sources, not human data.
Data Provenance: Not human data. "Phantom" signal sources were used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not mentioned.
Qualifications: Not applicable, as "phantom" signal sources were used, implying an engineered ground truth.

4. Adjudication method for the test set

Not mentioned. Not applicable to nonclinical phantom tests.

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

No. This is a nonclinical test of a hardware device. No mention of AI assistance or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The tests described are for the standalone device operating with phantom sources. There is no "algorithm only" or "human-in-the-loop" aspect to these nonclinical tests.

7. The type of ground truth used

Engineered ground truth (from "phantom" signal sources) for characteristics like localization accuracy, signal sensitivity, and background noise.

8. The sample size for the training set

Not applicable. This document describes tests for a medical device (hardware and associated electronics), not a machine learning model that would require a "training set."

9. How the ground truth for the training set was established

Not applicable (no training set).

Summary

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MAY 1 6 1996

51(K) SUMMARY

(a) (1) Submitted By: Biomagnetic Technologies, Inc. (BTi) 9727 Pacific Heights Blvd. San Diego. CA 92121

Telephone: (619) 453-6300 (619) 453-4913 Fax:

Eugene C. Hirschkoff, Ph.D. Contact: Director of Clinical Applications

Prepared: 15 May 1996

Name of Device: (2)
Proprietary name: Device trade name: Magnes® II Biomagnetometer Magnetic Encephalograph
(3) Substantial Equivalence:
The Magnes II Biomagnetometer system is substantially equivalent to the Magnes Biomagnetometer system currently manufactured and marketed by Biomagnetic Technologies, Inc. (Reference 510(k) K901215)
(4) Description of Device:
The Magnes II Biomagnetometer system utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in the brain. The signals are amplified, filtered and digitized by signal processing clectronics. The digitized signals are computer processed to produce displays of information about biomagnetic field strength, direction, and location.

Intended Uses: (2)
"The Magnes II Biomagnetometer is intenced for use in diagnostic procedures that require the measurement and display of extracranial magnetic fields and information about the electrical activity of the brain as inferred from those fields."

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Technological Characteristics: (6)
The Magnes II biomagnetometer system provides a second magnetic field sensor unit but is otherwise equivalent to the slandard Magnes Biomagnetometer system.

The same clectrical currents in the brain that produce electric voltages on the body surface also produce magnetic fields orthogonal to those currents. The magnetic fields are mathematically related to the electrical currents and voltages by the classical electromagnetic field equations of Maxwell, Lenz, and others.

The major technological difference between the Magnes II Biomagnetometer and conventional clectrical signal devices (EEG) is the use of superconducting magnetic field sensors. The magnetic field sensor detects and converts magnetic field energy to electrical signals without patient electrical contact. The electronic and computer subsystems are equivalent to processing systems in use by electrical signal devices.

Nonclinical Tests and Results: (b) (1)
Nonclinical tests involve verification of basic physical principles associated with the Typical examples are tests using "phantom" signal sources for technology. localization accuracy, characterization of signal sensitivity, and system background noise relative to biomagnetic signals of interest.

Test results comparing the response of the second Magnes sensor relative to the original Magnes signal sensor indicate that there is no significant difference in the performance of the Magnes II Biomagnetometer system for the detection and display of biomagnetic signals.

(2) Conclusions:
The addition of the second sensor to the Magnes Biomagnetometer system provides additional simultaneous coverage area for signal acquisition and reduction of overall recording time.

Measurement, display, and interpretation of biomagnetic ficids originating from electrical activity in the brain has been under development for at least the pass 30 years. Current technology has produced enhanced capability through implementation of multiple signal sensors. The Magnetometer system ropresents the latest implementation of this technology.

Any questions regarding the 510(k) summary may be directed to the contact person noted.

Regulation Number and Section

§ 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).