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510(k) Data Aggregation
(263 days)
The BMP MCG CS-MAG II Magnetocardiograph is intended for use as tool which non-invasively measures and displays the magnetic signals produced by the electric currents in the heart.
The BMP MCG CS-MAG II system will be used for diagnostic purposes in adult cardiology. Magnetocardiography (MCG) is a non-invasive, non-contact, radiation-free, multichannel body surface mapping technique to record biomagnetic signals from the heart generated by the same ionic currents underling the electrocardiogram. Compared to electrocardiography (ECG), MCG has similar morphological features such as T-, P-, and Q-waves, and the QRS complex. The advantages of MCGs over traditional ECGs are increased sensitivity to weak signals, lack of distortion from conductivity in body tissues, and presentation of direct current (DC) component signals and primary currents.
The provided text only contains very limited information regarding the device's testing and acceptance criteria. It focuses primarily on the predicate device, general device description, intended use, and a summary outlining what was tested rather than the specific quantitative acceptance criteria or the study proving these were met.
Here's what can be extracted based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| SQUID gradiometer sensitivity | Better than 3.5 fTrms/yHz at white frequency (to get clear signal from the magnetic field to voltage) |
| Dewar liquid capacity and boil-off rate | Minimal liquid capacity and boil-off rate (to get refill interval longer than 7 days) |
| Electronics filters | "analog filter: high pass, low pass, notch" (tested, but no specific performance metric given) |
| Electronics output amplifier | Output amplifier (tested, but no specific performance metric given) |
| Electronics automatic control of SQUID sensors | Automatic control of SQUID sensors (tested, but no specific performance metric given) |
| Software control | Controlling system (tested, but no specific performance metric given) |
| Software display | Display (tested, but no specific performance metric given) |
| Software signal processing | Signal processing (tested, but no specific performance metric given) |
| Software analysis (2D current map) | 2D current map (tested, but no specific performance metric given) |
| Gantry movement | Gantry movement (tested by inspection of specification, but no specific numeric or descriptive performance metric given) |
| Bed movement | Bed movement (tested by inspection of specification, but no specific numeric or descriptive performance metric given) |
| Bed alignment | Bed alignment (tested by inspection of specification, but no specific numeric or descriptive performance metric given) |
Missing Information: For many components, while "tested" is mentioned, specific numerical or descriptive acceptance criteria and their corresponding reported performance values are not provided. The text primarily states what was tested rather than the results against specific criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "The MCG system test included the system and each component," implying a system-level and component-level testing rather than a clinical study with a patient test set.
- Data Provenance: Not applicable, as there's no mention of patient data being used for a test set. This appears to be hardware and software functional testing rather than a clinical performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There is no mention of a clinical test set requiring expert-established ground truth. The testing described is technical validation of hardware and software specifications.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set or expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The document describes technical testing of the device's hardware and software components.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, this appears to be the type of study described, though it's a technical validation rather than a clinical performance study. The "MCG system test" focused on the performance of the system components (SQUID gradiometer, Dewar, Electronics, Software, Gantry, and Bed) in isolation, ensuring they meet their design specifications. There is no mention of human interaction or a human-in-the-loop performance evaluation.
7. Type of Ground Truth Used
- Technical Specifications / Design Requirements: The ground truth for this testing appears to be the device's own design specifications and functional requirements for its various components (e.g., SQUID sensitivity, Dewar boil-off rate, filter types, software functionalities, gantry/bed movements).
8. Sample Size for the Training Set
- Not applicable. The document does not describe any machine learning or AI component that would require a training set. The software testing mentioned is functional validation, not model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there's no mention of a training set or AI model, this information is not relevant.
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