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The S/5 Critical Care Monitor with L-ICU05 and L-ICU05A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, and neurophysiological status of all patients.

When the BIS module is used with the S/5 Critical Care Monitor with L-ICU05 and L-ICU05A, it is intended for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility patient care to monitor the state of the brain by data acquisition of EEG signals. The Bispectral index (B1S), a processed EEG variable, and one component of the BIS measurement, may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral index is a complex technology, intended for use only as an adjunct to clinical judgement and training. In addition, the clinical utility, risk/benefit, and application of BIS have not undergone full evaluation in the pediatric population.

The S/5 Critical Care Monitor with L-ICU05 and L-ICU05A software is indicated for use by qualified medical personnel only.

The two software options for the S/57M Critical Care Monitor are identical, except that the L-ICU05A is equipped with extended arrhythmia analysis capability. There are two monitor frame options; the new 5-module F-CU5(P) monitor frame and the 8-module F-CU8 monitor frame which can be extended with an Extension Frame. F-EXT4, via the Extension Module E-EXT. The monitor can be equipped with a Recorder Module, E-REC. The S/5TM Critical Care Monitor with L-ICU05 and L-ICU05A uses several types of plug-in measurement modules. The legacy Datex-Ohmeda M-series measurement modules can be used but they have been replaced by the new Eseries modules (510(k)'s submitted separately), which are basically face-lifted versions of the corresponding M-series modules (with the exception of E-REC and E-EXT) are the subject of separate 510(k)'s and are not part of this notification. The S/5TM Critical Care Monitor with L-1CU05 and L-ICU05A is typically furnished with a module that measures ECG, invasive and non-invasive blood pressures, pulse oximetry and temperature. Modules are placed in the S/5TM monitor frame and are automatically recognized by the monitor. The patient cables are connected to the module plug in jacks and then monitoring can begin. The S/5TM Critical Care Monitor with L-ICU05 and L-ICU05A can display measurements in the form of numeric values, traces and trends. Audible and visual alarms are used to indicate patient status. The priority profile of an alarm depends on the parameter. The S/5TM Critical Care Monitor with L-ICU05 and L-ICU05A is operated by a keyboard. Typically pressing a key results in a pop up menu appearing on the screen. Selections can then be made easily from the menu using a unique ergonomically designed pointing device on the keyboard called a ComWheel™. The software L-ICU05 and L-ICU05A perform some module related tasks like arrhythmia analysis, ST-values calculation, heart rate calculation. impedance and respiration rate calculation, energy expenditure calculation, EEG spectrum analysis evoked potential response averaging and entropy calculations. All the module communication is also handled in the main software. There are various optional types of keyboards, some are like standard keyboards and another is a hand-held Remote controller (REMCO) which is still directly connected to the S/5™ Critical Care Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. To facilitate quick access to menus, a bar code reader is also supported, although the bar code reader is not manufactured anymore.

The S/5™ Critical Care Monitor can be in a stand-alone or networked configuration. If networked, measurements are sent to the network for central station or monitor viewing. Trends can be sent via a network to a central computer for archiving.

The S/5 Critical Care monitor can also be upgraded to L-ICU05(A) software using the S/5 L.I.F.E. upgrade program that offers a means to continuously keeping products up-to-date, by upgrading modular anesthesia and critical care monitors and network products dating from back to 1992 to the latest 5/5 software level. Upgrading of modular monitors and network products is performed with one of the available U-LIFE upgrade kits. The kit includes all hardware and software components needed to make the monitor or network product compatible with the latest main software being delivered.

The provided text describes a 510(k) premarket notification for the Datex-Ohmeda S/5™ Critical Care Monitor with L-ICU05 and L-ICU05A Software, comparing it to a predicate device (K021376). The document focuses on demonstrating substantial equivalence through adherence to various international and national standards, rather than presenting a clinical study with acceptance criteria and device performance metrics.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies are not available in the provided text.

Based on the available information, here's what can be extracted:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) for the device. Instead, "acceptance criteria" are implied by the comprehensive list of national and international standards against which the device was assessed. The stated "device performance" is primarily that it conforms to these standards and is substantially equivalent to the predicate device in terms of safety and effectiveness.

Details Not Provided in the Document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present. The submission focuses on nonclinical testing against standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was a nonclinical safety and effectiveness assessment based on engineering and performance standards, not a clinical study requiring expert ground truth for interpretation outcomes.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of submission.
4. 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 patient monitor, not an AI-assisted diagnostic tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the "S/5™ Critical Care Monitor with L-ICU05 and L-ICU05A software" as a device that performs functions like arrhythmia analysis and ST-values calculation. It states that "The device has been thoroughly tested through validation and verification of specifications." This implies standalone testing of the software's performance against its specifications, but specific performance metrics are not given in this summary.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For nonclinical testing against performance standards, the "ground truth" would be the engineering specifications and the requirements outlined in the standards themselves. This is not clinical ground truth.
7. The sample size for the training set: Not applicable, as the document does not describe the development of a machine learning or AI model with a distinct training set. It refers to software for a patient monitor.
8. How the ground truth for the training set was established: Not applicable for the reasons mentioned above.

Conclusion from the document: The summary states that "The summary above shows that the Datex-Ohmeda S/5™ Critical Care Monitor with L-ICU05 and L-ICU05A Software is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software (K021376)." This conclusion is drawn from the assessment against the listed standards and the detailed analysis in the comparison document, implying that by successfully meeting these standards, the device's performance is deemed acceptable and equivalent to the predicate.

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