(252 days)
The Integrated CardioRespiratory (ICR) System, when used with ICR Acoustic Sensors and ECG Sensor Electrodes on the chest wall, is intended for use in acquiring and analyzing heart sound data and computing and reporting an estimate of left ventricle Ejection Fraction that is comparable to that derived by 2-D echocardiography. The device is not intended for continuous monitoring of Ejection Fraction.
The ICR System is not intended as a sole means of diagnosis. It does not supersede the judgment of the qualified medical personnel. The ICR System is intended to aid the physician in the evaluation of heart function. The interpretation of EF values offered by the ICR System are only significant when used in conjunction with physician over-read as well as consideration of all relevant patient data.
Indicated for use in adults only. The ICR System is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
The Integrated CardioRespiratory (ICR) System is a non-invasive skin adhering sensors and computer based device that allows for measurement of Ejection Fraction (EF). The ICR System includes four acoustic sensors and ECG electrodes that are placed on the patient's chest to collect signals, which are combined to compute the EF percentage value. The ICR System performs signal processing computation to identify and characterize amplitude and time of event characteristics of S1 and S2 heart sounds. The computed EF percentage value is presented to the clinician on the ICR Patient Monitor display.
The ICR System consists of the following components:
- ICR Acoustic Sensors
- ECG Sensor Electrodes
- ICR Sensor Application System
- ICR Patient Monitor
Here's an analysis of the provided text to extract information regarding the acceptance criteria and the study proving the device meets them:
Disclaimer: The provided text is a 510(k) summary, which is a regulatory document. It summarizes the device, predicate devices, and testing performed to demonstrate substantial equivalence. It does not typically contain the detailed raw data or full study reports that would include specific acceptance criteria thresholds or comprehensive statistical results for every performance metric. Therefore, some information requested might not be explicitly present and can only be inferred or stated as "not specified."
Acceptance Criteria and Device Performance
The document broadly states that the device was evaluated for "equivalence to the Echocardiography method" and "agreement... to cardiac Magnetic Resonance Imaging (cMRI) EF measurements." However, specific numerical acceptance criteria (e.g., "within X% difference" or "sensitivity > Y%") for these comparisons are not explicitly stated in the provided text. The performance is summarized qualitatively as "comparable" and "low and acceptable variability."
| Acceptance Criteria (Not explicitly stated numerically in the document) | Reported Device Performance (Qualitative Summary) |
|---|---|
| Equivalence to 2-D Echocardiography for Left Ventricle Ejection Fraction (EF) estimation | "the performance of the ICR system is comparable with the echocardiography method." |
| Agreement with Cardiac Magnetic Resonance Imaging (cMRI) for EF assessment (Gold Standard) | "evaluate the agreement of the ICR System to cardiac Magnetic Resonance Imaging (cMRI) EF measurements, with cMRI being considered the gold standard for EF assessment." (No direct statement of agreement achieved, but implies it was satisfactory enough for clearance). |
| Low Measurement Variability (Operator & Device) | "the ICR System has low and acceptable variability in EF measurements." |
| Software Verification and Validation | "meets the established specifications necessary for consistent performance." |
| Measurement Reproducibility | "meets the established specifications necessary for consistent performance." |
| Human Factors testing | (No specific performance metric mentioned, but implies it met requirements for safe and effective use) |
Study Details
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: "A total of 81 patients who arrived at the healthcare facility for some cardiac condition were enrolled."
- Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Not explicitly stated, but the phrase "patients who arrived at the healthcare facility for some cardiac condition were enrolled" suggests a prospective enrollment for the study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: The ground truth methods were "2-D echocardiography" and "cardiac Magnetic Resonance Imaging (cMRI)". These procedures are performed and interpreted by trained medical professionals (e.g., cardiologists, sonographers, radiologists). The document refers to "qualified medical personnel" in the Indications for Use, but doesn't specify expert qualifications for ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. The ground truth was established by comparison to echocardiography and cMRI, implying these methods served as the reference standard rather than human adjudication of the device's output.
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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. The study described is a direct comparison of the device's output (EF) against established medical imaging methods (echocardiography and cMRI), not an evaluation of human reader performance with and without AI assistance.
- Effect Size: Not applicable, as no MRMC study was performed to assess human reader improvement.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes. The "measurement validation study" evaluated the "equivalence of the ICR System to the Echocardiography method" and "agreement... to cardiac Magnetic Resonance Imaging (cMRI) EF measurements." This inherently describes the algorithm's performance in estimating EF independently, as its output (the EF percentage value) is directly compared to the reference standards. The device's output is "presented to the clinician on the ICR Patient Monitor display," meaning the algorithm generates the EF value.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The primary ground truths were 2-D Echocardiography and Cardiac Magnetic Resonance Imaging (cMRI) EF measurements. cMRI is explicitly stated as "considered the gold standard for EF assessment."
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The sample size for the training set:
- Not specified. The document only details the clinical study for the test set (81 patients). Information about the training set size or methodology is not included in this 510(k) summary.
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How the ground truth for the training set was established:
- Not specified. As the training set size and details are not provided, how its ground truth was established is also not mentioned.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).