(178 days)
The CardioFlux FAC Magnetocardiograph is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents of the heart.
The CardioFlux FAC Magnetocardiograph (MCG) is a biomagnetic sensing device that can record and display the magnetic fields generated by cardiac electrical activity. The CardioFlux FAC hardware connects to the Faraday™ Analytical Cloud (FAC) to allow access to a patient database and software for data analysis. The CardioFlux FAC MCG system consists of a patient table, a 6 x 6 array of optically pumped magnetometers covering roughly an area of 400 square centimeters and a shielding cylinder to reduce ambient electromagnetic interference during a patient scan. CardioFlux FAC is primarily controlled via software applications on a local computer. Data are displayed as 36 superimposed cardiocycles and magnetic field maps.
The provided text does not contain detailed acceptance criteria and the results of a specific study proving the device meets those criteria, as one would typically find in a detailed clinical performance study report. Instead, it describes a 510(k) summary for the CardioFlux FAC Magnetocardiograph, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Here's a breakdown of the information that is available, and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy against a gold standard) for the device's diagnostic performance. Instead, it discusses the device's ability to record magnetic signals and qualitative and quantitative agreement with the predicate device.
Reported Device Performance (from "Performance Testing"):
- Ability to record human cardiac biomagnetic signals: The device was able to record these signals from male and female adults.
- Agreement with predicate device: "Analysis of the magnetic field traces of each volunteer showed excellent qualitative and quantitative agreement between data acquired with the proposed device and data acquired with the predicate."
2. Sample Size Used for the Test Set and Data Provenance
The text states: "Performance Testing (head-to-head against the predicate device) to determine the ability of CardioFlux FAC to record human cardiac biomagnetic signals from male and female adults ranging in age from 23 to 77."
- Sample Size: Not explicitly stated as a number of participants. It says "each volunteer" but does not quantify the total number of volunteers.
- Data Provenance: Not specified (e.g., country of origin). It's a prospective head-to-head performance test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The performance test focused on comparing the device's output to a predicate device's output, not on an "expert ground truth" in a diagnostic context.
4. Adjudication Method for the Test Set
This information is not provided. As "expert ground truth" is not mentioned, an adjudication method for that purpose would not be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not mentioned. The performance testing described is a technical comparison of signal acquisition between the proposed device and the predicate, not a study involving human readers and diagnostic accuracy.
6. Standalone (Algorithm Only) Performance
The document describes the device's ability to "non-invasively measures and displays the magnetic signals produced by the electric currents of the heart." The performance testing focused on the device's ability to record these signals and its agreement with the predicate. This implies a standalone capability for signal acquisition and display, but not for diagnostic interpretation against a clinical ground truth.
7. Type of Ground Truth Used
The "ground truth" for the performance testing was essentially the measurements obtained from the legally marketed predicate device (Tristan Technologies Model 621/624 Biomagnetometer K151135). The assessment was based on "qualitative and quantitative agreement" between the proposed device's magnetic field traces and the predicate's traces. This is a technical (measurement) ground truth, not a clinical diagnostic ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
This information is not provided. The document describes the device as a biomagnetic sensing device that records and displays signals, with software for data analysis. It does not mention a machine learning component requiring a training set in the context of diagnostic interpretation.
9. How the Ground Truth for the Training Set Was Established
This information is not provided (see point 8).
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence for a new medical device mainly through technological comparison and non-clinical performance testing against a predicate device. It confirms the device's ability to acquire signals similar to the predicate but does not include the detailed clinical performance study information (such as diagnostic accuracy, specific acceptance criteria for performance metrics, expert adjudication, or MRMC studies) that would be needed to answer all parts of your request in a typical AI/diagnostic device context.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).