(88 days)
The S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software is intended for multiparameter patient monitoring with optional patient care documentation.
Indications for use:
The S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A 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™ Anesthesia Monitor with L-ANE02 and L-ANE02A 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™ Anesthesia Monitor with L-ANE02 and L-ANE02A software is also indicated for documenting patient care related information.
The S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software is indicated for use by qualified medical personnel only.
The S/5TM Anesthesia Monitor is a patient monitor, which displays the measurement of patient physiological parameters in the hospital setting.
The measurement of patient physiological parameters is accomplished by specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor. The care giver can select from a variety of available measurements (parameters) and apply those parameters that are best suited to patient care. Modules perform the functions of parameter measurement and minor data processing. The S/5TM Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing.
There are two software options available for the S/57M Anesthesia Monitor: L-ANE02 and L-ANE02A.
L-ANE02A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ANE02.
The S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A uses several types of plugin measurement modules are the subject of separate 510(k)'s and are not part of this notification. The S/5TM Anesthesia Monitor with L-ANE02 and L-ANE02A 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/57M 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/57M Anesthesia Monitor with L-ANE02 and L-ANE02A 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/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A 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-ANE02 and L-ANE02A 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 and evoked potential response averaging. All the module communication is also handled in the main software. The software L-ANE02 and L-ANE02A also include the option of creating patient care documentation. The trend information is automatically transferred to the anesthetic record, and the related events and medication can be easily entered with the same user interface as the monitor itself. 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/5TM Anesthesia Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper software, patient related care events are documented using the keyboard. To facilitate quick access to menus, a bar code reader is also available. The S/5TM Anesthesia 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.
I am sorry, but based on the provided text, there is no information about explicit acceptance criteria or a specific study proving the device directly meets acceptance criteria for improved arrhythmia analysis (L-ANE02A software). The document focuses on regulatory approval (510(k) submission) for a modified patient monitor by demonstrating substantial equivalence to a predicate device.
Here's a breakdown of why I cannot fulfill your request with the given information:
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Acceptance Criteria and Reported Device Performance: The document lists several recognized safety and performance standards (like IEC, EN, CAN/CSA, ISO, UL, ANSI/AAMI, FDA 21 CFR 898.12) that the device complies with. These are general standards, not specific acceptance criteria for a particular feature like arrhythmia detection. There are no reported performance metrics for the device (e.g., sensitivity, specificity, accuracy) in relation to arrhythmia detection or any other specific physiological parameter.
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Sample Size and Data Provenance: This information is completely absent. The document discusses device modifications and compliance with standards, but not the methodology of a study involving a test set, its size, or its origin.
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Number and Qualifications of Experts: Not mentioned.
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Adjudication Method: Not mentioned.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. The document describes a "standalone" device (patient monitor) and its software, not an AI-assisted interpretation tool for human readers.
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Standalone Performance Study: The document states, "Uses an arrhythmia analysis version which has an improved vfib algorithm compared to arrhythmia analysis version submitted in the predicate 510(k)." This implies an improvement in algorithmic performance. However, there is no detailed standalone study presented with performance metrics (e.g., sensitivity, specificity for vfib detection), sample sizes, or ground truth methodology to quantify this improvement. The focus is on demonstrating overall safety and effectiveness through compliance with general standards and substantial equivalence, rather than a detailed performance study of a specific algorithm.
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Type of Ground Truth: Not specified. If an arrhythmia study were conducted, the ground truth would likely be expert-adjudicated ECGs, but this is not detailed in the provided text.
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Sample Size for Training Set: Not applicable/not mentioned. This isn't a machine learning algorithm where a distinct "training set" would be referenced in this context. While the software has an "improved vfib algorithm," the development and validation data for this algorithm are not disclosed here.
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Ground Truth for Training Set: Not applicable/not mentioned.
In summary: The provided 510(k) summary focuses on demonstrating that the Datex-Ohmeda S/5™ Anesthesia Monitor with L-ANE02 and L-ANE02A software is substantially equivalent to a predicate device and complies with various safety and performance standards. It does not contain the details of a specific clinical or technical study that defines acceptance criteria for its arrhythmia analysis capability and then presents data to show those criteria were met. The claim of an "improved vfib algorithm" is stated, but without supporting study data in this document.
§ 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.