Search Results

The CardioQ-EDM series fluid management and cardiac output monitoring systems are designed to provide clinicians with real-time information about patients left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM series beat to beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward.

The CardioQ-EDM series monitors when used in Flow Monitoring Mode (esophageal Doppler) or Pressure Monitoring Mode (EDM+ only) are intended for use with adult and pediatric patients. When the CardioQ-EDM series monitors are used for High-Definition Impedance CardioGraphy with a PhysioFlow Q-Link module the intended use is for adult patients only.

The CardioQ-EDM series are medical instruments designed to monitor cardiac function and fluid status. The CardioQ-EDM & EDM+ achieve this by combining Doppler measurements of the blood flow (4MHz continuous wave ultrasound) to monitor and quantify the blood flow in the descending thoracic aorta. In addition to this the CardioQ-EDM+ previously introduced as an upgrade to the EDM under (K132139) allows additional Pulse Pressure Waveform Analysis (PPWA) through arterial blood pressure based parameters slaved from a high-end monitor.

The CardioQ-EDM (K111542) & Cardio EDM+ (K132139) have now been introduced with the addition of a USB Hub accessory and software modifications that allow the CardioQ-EDM series monitors to display hemodynamic parameters from the coupled together hemodynamic impedance cardiography device.

The addition of USB Hub accessory and software modifications allow the CardioQ-EDM series monitors to become a non-invasive cardiac output measurement system which displays hemodynamic parameters, allowing analysis of a trans-thoracic impedance cardiography signal & cardiac output monitoring. The only addition to the CardioQ-EDM & CardioQ-EDM+ is the enabling of HD-ICG functionality through the USB Hub accessory introduction and software modifications to display the hemodynamic parameters from the coupled hemodynamic impedance cardiography device.

The provided document is a 510(k) summary for the Deltex Medical CardioQ-EDM and Deltex Medical CardioQ-EDM+ device. It outlines the regulatory submission, device description, intended use, technological features, and a summary of completed testing.

However, the document does not contain any information about acceptance criteria or a study that specifically proves the device meets acceptance criteria related to its performance in terms of accuracy or efficacy, particularly concerning AI or algorithms. The submission focuses on substantial equivalence to predicate devices, primarily due to software modifications and the addition of a USB hub accessory to enable the display of hemodynamic parameters from a coupled impedance cardiography device.

Therefore, I cannot extract the detailed information requested in the prompt. The document explicitly states:

• "No Acoustic Output Testing has been conducted, because the CardioQ-EDM series monitors are only displaying data rather than performing any primary calculations are conducted by the hemodynamic impedance cardiography device coupled to the CardioQ-EDM series monitors."
• "No animal testing was conducted in support of this 510(k)."
• "No clinical testing was conducted in support of this 510(k)."

The "Bench Testing" mentioned is comparative and aims to show that "the software modifications and introduced USB Hub accessory have enabled additional HD-ICG functionality to be introduced to the existing CardioQ-EDM series monitors" and that "the software correctly displays the information received from the coupled hemodynamic impedance cardiography device without any manipulation of the coupled device." This is a functional verification, not a performance study against specific acceptance criteria for a new clinical claim or algorithm.

The document discusses "Letter-to-File Changes" for "Addition of Cardiac Power (CPO) and Cardiac Power Index (CPI)" and "Addition of Elastance (Ea) and Dynamic Arterial Elastance (Eadyn)," citing published papers to validate the use of these formulae. This indicates that the device displays these calculated parameters, but the 510(k) submission itself does not contain a study proving the device's performance in calculating or displaying these against acceptance criteria from a statistical clinical trial.

In summary, based on the provided text, the document does not contain the information required to answer your specific questions regarding acceptance criteria and performance studies for an AI/algorithm-driven device. The device described here is a display unit for parameters calculated by another coupled device and its assessment is for substantial equivalence relating to software and hardware changes enabling this display functionality.

Ask a specific question about this device

The Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM beat-to-beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward.

The Deltex Medical CardioQ-EDM series are medical instruments designed to monitor cardiac function and fluid status. The CardioQ-EDM series combine Doppler measurement of the blood flow (4MHz continuous wave ultrasound) with Pulse Pressure Waveform Analysis (PPWA) to monitor and quantify the blood flow in the descending thoracic aorta and hence calculate other clinically significant information.

The provided document is a 510(k) premarket notification for the Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM, a cardiovascular blood flowmeter. The submission focuses on minor software changes to extend the range of volumetric calculations and accommodate future probe additions, rather than a new standalone device with extensive clinical studies. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, or human-in-the-loop performance is not present.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of patient data. The testing described focuses on software functionality.

• Test Set Sample Size: Not applicable in the context of patient data. Testing involved simulation and code examination concerning formula selection and calculation.
• Data Provenance: Not applicable, as no patient data was used for this particular submission. The changes are software-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for the software's functionality was established through internal code examination and "by hand" calculations during simulation testing. No external experts or medical professionals were mentioned for this specific validation.

4. Adjudication method for the test set

Not applicable. The validation was based on software implementation and calculation accuracy, not on expert adjudication of clinical data.

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

No. This document describes a software update for a medical device that measures hemodynamic parameters, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a way. The testing focused on the algorithm's functional correctness ("software correctly implements the formula and algorithms" and "values displayed match those calculated 'by hand'"). However, this is distinct from "standalone performance" in the context of a diagnostic AI algorithm. Here, it refers to the accuracy of the device's internal calculations.

7. The type of ground truth used

For the specific software changes:

• Ground Truth: Verification that the software's internal logic for probe identification, formula selection, and volumetric calculations aligns with predefined expectations and manual calculations. This assumes the underlying physiological models and formulas used are already well-established.

8. The sample size for the training set

Not applicable. This submission concerns a software update to an existing device, primarily focused on formula selection and calculation. It does not involve machine learning or AI models that require a "training set" of data.

9. How the ground truth for the training set was established

Not applicable, as there was no training set for a machine learning algorithm.

Ask a specific question about this device