(258 days)
CorSens Device records vibrational waveforms produced by the heart contractions and transmitted to the chest wall. CorSens Device may be used as a tool to measure the timing of part of the cardiac cycle for adult population.
CorSens Device senses and analyzes the mechanical movement of the heart. This is accomplished by 3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motions.
The CorSens Device, a Ballistocardiograph, records vibrational waveforms produced by heart contractions to measure the timing of part of the cardiac cycle in adults.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format. However, it indicates a high-level performance expectation and makes a direct comparison to an established clinical method.
| Acceptance Criterion (Inferred from text) | Reported Device Performance |
|---|---|
| Ability to provide accurate timing of part of the cardiac cycle events. | "CorSens Device can provide accurate timing of part of the event of the cardiac cycle, at least as accurate as the echocardiogram." |
| Safety and efficacy comparable to predicate devices. | "Results of tests and validations, performed with the proposed CorSens Device demonstrates that it is as safe and effective as its primary predicate device, without raising any new safety and/or effectiveness concerns." |
2. Sample Size and Data Provenance for Test Set
The provided document does not explicitly detail a specific 'test set' with a defined sample size for a clinical study comparing the CorSens Device to an echocardiogram. It refers to a "comparison test" with echocardiogram, stating: "In addition to the verification and validation testing, a comparison test with the current common clinical practice to measure the timing of the events in the cardiac cycle, an Echocardiogram, was conducted."
Without further information, the specific sample size, country of origin, or whether the data was retrospective or prospective cannot be determined from this document.
3. Number and Qualifications of Experts for Ground Truth
The document does not specify the number or qualifications of experts used to establish ground truth for any test set. The ground truth (echocardiogram measurements) would typically be established by trained sonographers and/or cardiologists.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for the comparison test with echocardiogram.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, information on the effect size of human readers improving with or without AI assistance is not applicable or provided.
6. Standalone (Algorithm Only) Performance Study
The document indicates that "the proposed CorSens Device safety and the efficacy of the system were established by performance lab tests and Software V&V." While this suggests evaluation of the device's technical performance in isolation, it does not specifically describe a 'standalone (algorithm only without human-in-the-loop performance)' study in the way it might be discussed for an AI-driven diagnostic algorithm. The device is a measurement tool, and its 'performance' inherently involves its ability to capture and process data to produce timing measurements.
7. Type of Ground Truth Used
For the comparison test, the ground truth used was echocardiogram. The text explicitly states: "a comparison test with the current common clinical practice to measure the timing of the events in the cardiac cycle, an Echocardiogram, was conducted."
8. Sample Size for the Training Set
The document does not mention any specific training set or its sample size. This implies that the device's core functionality does not rely on a machine learning model that requires a discrete training phase with labeled data in the way many contemporary AI devices do. The device's operation is based on established biophysical principles of measuring vibrational waveforms.
9. How Ground Truth for the Training Set Was Established
Since no training set is mentioned as part of the device's development or validation process in this document, the method for establishing its ground truth is not applicable or provided. The device likely operates on fixed algorithms rather than a trained machine learning model.
§ 870.2320 Ballistocardiograph.
(a)
Identification. A ballistocardiograph is a device, including a supporting structure on which the patient is placed, that moves in response to blood ejection from the heart. The device often provides a visual display.(b)
Classification. Class II (performance standards).