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510(k) Data Aggregation
(204 days)
Retia Medical, LLC
The Argos Cardiac Output monitoring device is intended for use on patients above the age of 18. It is intended to be used as a hemodynamic monitor for monitoring cardiac output and its derived parameters on patients in the intensive care unit or the operating room.
The Argos Monitor is a portable hemodynamic monitor that calculates Cardiac Output and other derived parameters, including cardiac index (CI), stroke volume (SV), stroke volume index (SVI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), mean arterial pressure (MAP), heart rate (HR), and pulse pressure variation (PPV) based on a proprietary algorithm that analyzes the blood pressure waveform and user-entered patient demographic information (age, height weight and gender). The blood pressure waveform is input into the monitor via a connection with either a radial arterial catheter or the analog blood pressure signal output of a vital signs monitor. The scientific method that underlies the algorithm is based on a novel signal processing technique to determine the parameters of the well-established Windkessel model of the circulation in order to calculate cardiac output.
The Argos Monitor comes with a touchscreen monitor and computer system enclosed in a rigid plastic housing and a power cable. Cables to connect the monitor to a radial blood pressure transducer or to the analog blood pressure signal output of a vital signs monitor are also provided according to the setup and needs of the individual institution. The Monitor may be attached to a pole or a table stand via a standard screw interface pattern.
The requested information about the acceptance criteria and the study proving the device meets them is extracted from the provided text.
Based on the provided text, the device in question is the Retia Medical, LLC: Argos Monitor, which calculates Cardiac Output and other derived parameters.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria for specific performance metrics (e.g., accuracy thresholds for Cardiac Output). Instead, the acceptance is framed in terms of equivalence to a predicate device and meeting safety and performance standards.
| Acceptance Criteria Type | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Clinical Performance | The device should demonstrate accuracy in calculating cardiac output comparable to or better than the predicate device when compared to a reference standard (pulmonary artery catheter). The document states the Argos algorithm should have "as low or lower errors than the predicate Edwards device" and "perform as well as or better than the predicate device." | "The accuracies of the Argos monitor and the predicate device were assessed using the pulmonary artery catheter as the reference for all measurements. The data demonstrated that the Argos monitor has the same or lower errors in measurement compared to the reference than the errors shown by the predicate device compared to the reference." |
| Safety and Effectiveness | The device should be as safe and as effective as the predicate device for its intended use. | "The Argos monitor passed all verification and validation testing and was shown to be safe, effective and substantially equivalent to the predicate device." And "The Retia Argos monitor has been shown to be safe and effective as the predicate." |
| Functional and Performance Testing | The device must pass a comprehensive set of engineering, software, and usability tests. This includes IEC 60601-1, IEC 60601-1-2, IEC 60601-2-34, IEC 60601-1-8, ISTA 2A, and ISO 10993-1 standards requirements. | "The Argos CO Monitor has successfully passed functional and performance testing, including electrical and mechanical testing, environmental testing, shipping tests, software verification and validation, clinical usability testing, and comparison testing with the predicate device on clinical data." And "The monitor was assessed and/or tested for and met the following standard requirements: 1. IEC 60601-1, 2. IEC 60601-1-2, 3. IEC 60601-2-34, 4. IEC 60601-1-8, 5. ISTA 2A, 6. ISO 10993-1." |
| Usability | Clinical users (physicians and nurses) should be able to successfully set up, connect, configure, and interpret information from the monitor. | "Clinical usability testing for the monitor was performed on 15 clinical users, comprising physicians and nurses who work in the ICU and OR. All users were successfully able to set up the monitor, connect the appropriate cables, enter the patient demographic information, configure the displayed parameters, and interpret the information provided, including alarms." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Performance Test Set: 40 patients (20 from the Operating Room (OR) and 20 from the Intensive Care Unit (ICU)).
- Data Provenance: The document does not explicitly state the country of origin. It describes the study as "clinical testing" and "clinical data," implying a prospective collection of data in a clinical setting for the purpose of this study. The timeframe is not specified beyond "No adverse effects or complications were noted during the study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing the ground truth. The ground truth (reference standard) used was an invasive method: "the pulmonary artery catheter as the reference for all measurements." This is a direct measurement, and thus expert interpretation for ground truth establishment might not be applicable in the same way it would be for an image-based diagnostic study requiring consensus reads.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set, as the ground truth was established by direct measurement via a pulmonary artery catheter, not by expert consensus. The comparison was between the device's output, the predicate device's output, and the pulmonary artery catheter's output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not conducted. This study focused on device performance against a reference standard and comparison to a predicate device, not on the improvement of human reader performance with AI assistance. The device is a "Single-Function, Preprogrammed Diagnostic Computer" that measures physiological parameters.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, a standalone performance assessment was conducted implicitly. The "accuracies of the Argos monitor and the predicate device were assessed using the pulmonary artery catheter as the reference." This directly measures the algorithm's output against the ground truth without human intervention in the loop of the measurement process. Human users were involved in setting up and interpreting the device, but the accuracy assessment was of the device's calculated parameters.
7. The Type of Ground Truth Used
The ground truth used for the clinical performance assessment was outcomes data in the form of direct measurements from a pulmonary artery catheter (PAC). The PAC is considered a gold standard for cardiac output measurement.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set. It only mentions that the algorithm is "proprietary" and based on a "novel signal processing technique."
9. How the Ground Truth for the Training Set was Established
The document does not describe how the ground truth for the training set was established. It focuses on the validation of the device's performance against the predicate and a reference standard.
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