(69 days)
The S/5™ Compact Critical Care Monitor with L-CICU05 and L-CICU05A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients.
The S/5™ Compact Critical Care Monitor with L-CICU05 and L-CICU05A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents.
The S/5™ Compact Critical Care Monitor with L-CICU05 and L-CICU05A software is indicated or use by qualified medical personnel only.
The two software options for the S/5™ Compact Critical Care Monitor are identical, except that the L-CICU05A is equipped with extended arrhythmia analysis capability.
The S/5™ Compact Critical Care Monitor with L-CICU05 and L CICU05A uses several types of plug-in measurement modules. The legacy Datex-Ohmeda M-series or E-series measurement modules are used. Modules are the subject of separate 510(k)'s and are not part of this notification.
The S/5TM Compact Critical Care Monitor with L-CICU05 and L-CICU05A 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/5™ 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 Compact Critical Care Monitor with L-CICU05 and L-CICU05A 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 aların depends on the parameter.
The S/5TM Compact Critical Care Monitor with L-CICU05 and L-CICU05A 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-CICU05 and L-CICU05A perform some module related tasks like arrhythmia analysis, ST values calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation and EEG spectrum analysis evoked potential response averaging 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 (K-CREMCO) which is still directly connected to the S/5™ Compact 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/5TM Compact 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-to-monitor viewing. Trends as well as the patient care documentation can be sent via a network to a central computer for archiving. Networking can be hardwired or wireless.
The S/5 Compact Critical Care Monitor can also be upgraded to L-CICU05(A) software using the S/5 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 2000 to the latest S/S 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 currently available U-LIFE upgrade kit codes for S/5 Compact Critical Care Monitor are:
ULIFE4-00-03 with U-CICU05 and User's Guide ULIFE4-00-03 with U-CICU05A and User's Guide
This 510(k) summary describes a premarket notification for the "Datex-Ohmeda S/5™ Compact Critical Care Monitor with L-CICU05 and L-CICU05A Software." It states that the device has been assessed against a list of international and national standards for medical devices, and asserts that "details of conformity are presented in the attached 510(k) notification." It further concludes that "The device has been thoroughly tested through validation and verification of specifications."
However, this document does not provide specific acceptance criteria or the details of any study that proves the device meets those criteria. Instead, it relies on conformance to various safety and performance standards for medical devices and a claim of substantial equivalence to a predicate device. Typically, acceptance criteria and performance data would be found within the full 510(k) submission, not just the summary.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot provide. The document states the device was "assessed against the standards below" and "thoroughly tested through validation and verification of specifications." It lists numerous IEC, EN, CAN/CSA, ISO, UL, and ANSI/AAMI standards (e.g., IEC 60601-1, IEC 60601-2-27, ANSI/AAMI ES-1, ANSI/AAMI EC57). These standards cover general safety, electrical safety, electromagnetic compatibility, and performance requirements for specific medical devices like arrhythmia detectors and ECG monitors. However, the document does not present specific quantitative acceptance criteria derived from these standards (e.g., "sensitivity for arrhythmia detection > 90%") nor does it provide reported device performance values against such criteria. The "Conclusion" only states substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot provide. No information on sample sizes, test sets, data provenance (country, retrospective/prospective), or data types (e.g., patient data, simulated data) is included.
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 provide. The document does not describe the methodology for establishing ground truth, nor does it mention any expert involvement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot provide. No information on adjudication methods is present.
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:
- Cannot provide. The device is a patient monitor with software for analysis (e.g., arrhythmia, ST-segment), not an AI-assisted diagnostic tool for human readers in the traditional sense of an MRMC study. It's designed to provide data and alarms directly. No MRMC study or similar comparative effectiveness study with human readers is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implied, but no details provided. The "validation and verification of specifications" implies testing of the algorithms (e.g., for arrhythmia analysis, ST calculation) in a standalone capacity (as part of the device software). However, no specific details of such standalone performance or testing methodologies are provided beyond the general statement of conformity to standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot provide. The document does not describe how ground truth was established for any testing conducted. For performance claims related to arrhythmia or ST-segment analysis, ground truth would typically come from expert-reviewed ECG waveforms or reference devices.
8. The sample size for the training set:
- Not applicable / Cannot provide. This device is from 2007 and focuses on software updates for a patient monitor, performing calculations and analyses rather than using "AI" in the modern machine learning sense that involves explicit training sets. The software performs "model-based" or "rule-based" analyses rather than being "trained" on data. Therefore, there's no "training set" in the context of deep learning or advanced machine learning.
9. How the ground truth for the training set was established:
- Not applicable / Cannot provide. For the same reasons as point 8, there is no "training set" to establish ground truth for.
In summary, this document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device and adherence to recognized safety and performance standards. It does not contain the detailed clinical or validation study results with specific acceptance criteria and performance metrics that would typically be found in a full submission.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.