(23 days)
The ECOM CV4 (Endotracheal Cardiac Output Monitor) System is intended for the monitoring of cardiac output by impedance cardiography while providing airway management by oral intubation with an ECOM Endotracheal Tube. The ECOM CV4 System is indicated for use in patients who are expected to be intubated for 24 hours or less and in whom an arterial pressure line is used.
The ECOM CV4 System will display the R-Wave Detection and the Impedance Waveforms as well as the patient's Cardiac Output (CO), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressures.
The ECOM CV4 System consists of an ECOM CV4 Endotracheal Tube and an integrated ECOM CV4 Monitor. The ECOM CV4 Monitor includes a Tube Cable, Arterial Pressure Cable, ECG Cable, ECG Lead Wire, and power cordset.
The ECOM CV4 System applies a high frequency, low amplitude electrical current and measures the resulting voltage directly from the tracheal mucosa by way of an ECOM CV4 Endotracheal Tube. The ECOM CV4 Monitor will display the tube and surface R-Wave and the Impedance Waveforms as well as the patient's Caridac Output (CO), Heart Rate (HR), Stroke Volume (SV), Systolic and Diastolic Pressures.
The provided document describes the ECOM CV4 System, an Endotracheal Cardiac Output Monitor. However, the document (a 510(k) summary) focuses on regulatory clearance and substantial equivalence to a predicate device, rather than a detailed study proving performance against specific acceptance criteria.
The clinical performance section states: "The ECOM CV4 System performance was tested with clinical data and the results met the acceptance criteria." Unfortunately, the document does not specify what those acceptance criteria were, nor does it provide details about the clinical study itself.
Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of what can and cannot be provided based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NOT SPECIFIED | "met the acceptance criteria" |
Reasoning: The document explicitly states: "The ECOM CV4 System performance was tested with clinical data and the results met the acceptance criteria." However, it does not define what those acceptance criteria were (e.g., specific accuracy thresholds, precision values, sensitivity, specificity, etc.).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Cannot be determined from the provided text. The document only mentions "clinical data" was used but gives no details about the sample size, its origin, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Cannot be determined from the provided text. The document does not describe how ground truth was established, which experts were involved, or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Cannot be determined from the provided text. There is no information regarding any adjudication process for the test set.
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
Not applicable/Cannot be determined. This device is an Endotracheal Cardiac Output Monitor, which outputs physiological measurements (Cardiac Output, Heart Rate, Stroke Volume, Pressures). It is not an AI-assisted diagnostic imaging system that involves human readers interpreting images. Therefore, a Multi-Reader Multi-Case (MRMC) study and "human readers improve with AI vs without AI assistance" are not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The device itself performs the measurement and displays the output (CO, SV, HR, etc.). While a human monitors and uses this information, the "performance" described (measuring cardiac output) is inherent to the device's function, implying a standalone assessment of its measurement capabilities. However, specific standalone performance metrics (e.g., accuracy against a gold standard) are not provided in detail beyond "met the acceptance criteria."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Cannot be determined from the provided text. The document mentions "clinical data" but does not specify the ground truth methodology used to validate the ECOM CV4's measurements. For cardiac output monitors, ground truth typically involves a more invasive, established method (e.g., pulmonary artery catheter thermodilution) against which the new device's readings are compared. This information is absent.
8. The sample size for the training set
Not applicable/Cannot be determined from the provided text. The ECOM CV4 is described as measuring physiological parameters via impedance cardiography. It's not a machine learning/AI device in the modern sense that typically has distinct "training" and "test" sets of data for algorithm development. Its "performance" refers to the accuracy and reliability of its physiological measurements, which would be validated against a reference method rather than trained on a dataset.
9. How the ground truth for the training set was established
Not applicable/Cannot be determined from the provided text. See explanation for point 8.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.