(17 days)
The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A software is intended for multiparameter patient monitoring with optional patient care documentation.
The S/5TM Compact Anesthesia Monitor with L-CANE05 and I -C ANE05A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory. ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response entropy) and neurophysiological status of all hospital patients. The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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 Anesthesia Monitor with L-CANE05 and L-CANE05A software is also indicated for documenting patient care related information. The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05 A software is indicated for use by qualified medical personnel only.
The S/5™ Compact Anesthesia Monitor with L-CANE05 and L CANE05A uses several types of plug-in measurement modules. Datex-Ohmeda M-series measurement modules or E-series modules are used. The S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A 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-CANE05 and L-CANE05A 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. The software L-CANE05 and L-CANE05A also include the option of creating patient care documentation. The trend informatically 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 (K-CREMCO) which is still directly connected to the S/5TM Compact 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 supported, although the bar code reader is not manufactured anymore. The S/5™ Compact 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. Networking can be hardwired or wireless. The S/5 Compact Anesthesia Monitor can also be upgraded to L-CANE05(A) software using the S/5 L.I.F.E. upgrade program that offers a means to continuously keeping products upto-date, by upgrading modular anesthesia and critical care monitors and network products dating from back to 2000 to the latest S/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 is a 510(k) Premarket Notification Summary for the Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE05 and L-CANE05A Software. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain the type of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, ground truth methodologies, or MRMC study results) that would typically be found in an clinical trial report or a comprehensive technical performance study.
Therefore, I cannot extract the requested information. The document states:
- "The device has been thoroughly tested through validation and verification of specifications."
- It lists numerous IEC, EN, CAN/CSA, ISO, UL, and ANSI/AAMI standards against which the device was assessed.
However, it does not provide:
- A table of acceptance criteria and reported device performance: This is not available in the document. It only states that the device was "assessed against" and "thoroughly tested through validation and verification of specifications" according to various standards. Specific performance metrics against acceptance criteria are not presented.
- Sample size used for the test set and data provenance: No information on test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective) is provided.
- Number of experts used to establish ground truth and qualifications: No information on experts or ground truth establishment is provided.
- Adjudication method: Not mentioned.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned. The document primarily focuses on demonstrating substantial equivalence based on technical characteristics and general safety standards.
- Standalone (algorithm only) performance: While the document mentions a "new improved arrhythmia detection and analysis algorithm," it does not provide standalone performance metrics for this algorithm.
- Type of ground truth used: Not specified.
- Sample size for the training set: Not mentioned.
- How ground truth for the training set was established: Not mentioned.
The document's primary argument for meeting acceptance criteria implicitly relies on its compliance with known medical device standards and its substantial equivalence to a previously cleared predicate device, rather than presenting a novel clinical performance study with detailed performance metrics.
§ 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.