Search Results

The Datex-Ohmeda S/5™ Cardiac Output and SvO2 module, E-COPSv and accessories is intended for use with Datex-Ohmeda modular monitors for cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2), and invasive blood pressure monitoring of hospitalized patients.

The Datex-Ohmeda S/5™ Cardiac Output and SvO2 module, E-COPSv and accessories is used for monitoring cardiac output (C.O.), right ventricular ejection (REF), mixed venous oxygen saturation (SvO2), and invasive blood pressure of hospitalized patients. The device is indicated for use by qualified medical personnel only.

E-COPSv is a single-width plug-in parameter module for a Datex-Ohmeda S/5 modular monitoring system. E-COPSv is used for monitoring cardiac output (C.O.), right ventricular ejection fraction (REF) and mixed venous oxygen saturation (SvO2) of hospitalized patients. Invasive pressure measurement is also available. All measurements are invasive. The E-COPSv module can be used in any of the four Datex-Ohmeda modular monitoring systems with 510(k) clearances: Anesthesia Monitor AM, Compact Anesthesia Monitor CAM, Critical Care Monitor CCM, or Compact Critical Care Monitor CCCM. The Cardiac Output, SvO2 or invasive pressure signal can be displayed on the monitor screen. The waveform size, color and sweep speed can be adjusted. The E-COPSv module calculate a number of parameters related to oxygenation or hemodynamics. All the calculated parameters can be selected on the display, and trended. The Cardiac Output and SvO2 accessories are the same for the E-COPSv module and the predicate device, the M- COPSv (K961063). Accessories that are in contact with the patient are CE-marked by Baxter and distributed by GE Healthcare.

The provided text describes a 510(k) premarket notification for the Datex-Ohmeda S/5™ Cardiac Output and SvO2 Module, E-COPSv and accessories. This submission focuses on demonstrating substantial equivalence to a predicate device (Datex-Ohmeda M COPSv Module, K961063) rather than presenting a de novo study with acceptance criteria and device performance as typically understood for AI/ML or novel diagnostic devices.

Therefore, many of the requested categories (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or explicitly stated in this type of submission.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed performance results in terms of sensitivity, specificity, accuracy, etc., as would be common for AI/ML diagnostics. Instead, the "acceptance criteria" are implied by the conformity to various medical device standards and the demonstration of substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on nonclinical testing and comparison to a predicate device, not a clinical study with a distinct test set involving patient data.

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)

Not applicable. There is no mention of a separate "test set" and no experts establishing ground truth in the context of a new diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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. This device is a physiological monitor, not an AI-assisted diagnostic tool involving human readers.

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

This concept is not directly applicable in the context of this device. The device itself is a standalone module for monitoring. Its "performance" is assessed through engineering validation and verification against its specifications and comparison to the predicate, rather than an algorithm's performance in isolation from a human operator. The document states it has been "thoroughly tested through validation and verification of specifications."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined for AI/ML diagnostics is not present. The validation of this device relies on:

• Engineering Specifications: The device's measurements (C.O., SvO2, invasive pressure) are compared against established engineering and physiological standards.
• Predicate Device Comparison: The "ground truth" for demonstrating substantial equivalence is the previously cleared predicate device, M-COPSv (K961063), and its established safety and effectiveness.
• Compliance with Standards: Adherence to a long list of international and national medical device standards (e.g., IEC 60601 series, ISO 14971).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Ask a specific question about this device