(119 days)
The MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories is intended for multiparameter patient monitoring.
The MRI Monitor with I -CANE05 or L-CANE05 A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories is indicated for monitoring of hemodynamic (comprising ECG (including heart rate, ST-segment and arrhythmia), NIBP, SpO2, and invasive blood pressure), respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE, Gas exchange monitoring is not indicated in the presence of N2O+O2 mixtures), status of hospital patients during magnetic resonance scanning.
The NIBP measurement is indicated for patients who weigh 5kg (11 lb) and up. The MRI Monitor with L-CANE05 or L-CANE05A software is also indicated for documenting patient care related information.
The MRI Monitor with L-CANE05 or L-CANE05A software, module options N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN, E-MRICAiOVX, E-MRICAiOV, E-MRICAiO, E-MRICO and accessories is indicated for use in the MR environment up to 300 Gauss with static magnets up to 3.0 Tesla. SpO2 and ECG monitoring is indicated only with accessories (OXY-FMR, OXY-WMR, 897986 (ECG cable, AAMI) and 897987, ECG Cable, IEC) specifically designed for the MR environment.
The MRI Monitor with L-CANE05 or L-CANE05A software is indicated for use by qualified medical personnel only.
The MRI Monitor has the following key components: MRI Shield in which the Compact Monitor Frame is placed, Monitor software and Built-in measurement modules. The optional components consist of Remote Controller, Anesthesia Record Keeper Keyboard and an aluminum/plastic MRI cart with locking casters.
The MRI Monitor can be controlled by the keys on the monitor's keyboard, Remote Controller or by Active Remote Screen keyboard. Function keys provide direct access to menu functions determined to be most important to the user. The ComWheel™ provides access to any menu function. The command board located on the lower front face of the monitor contains seventeen function keys, a wheel (ComWheel) for selection of monitor from menus as well as the on/off switch for the monitor. Function keys provide direct access to menu functions determined to be most important to the user. The ComWheelTM provides access to any menu function. There are keys on the monitor's side panel for ON/Standby, NIBP, Invasive Pressures and Recorder functions. With these keys, you can start or end a function immediately.
The built-in recorder is a thermal printer and records up to three real time waveforms simultaneously or displays recordings of numerical information in horizontal and vertical plane. The recorder prints up to 24 hours or graphical and numerical trend data.
The remote controller (K-CREMCO) has twelve function keys and a ComWheel for accessing all other monitor functions. It also has some direct function keys, which start or end a function immediately. To enter functions that do not have their own key, press the Menu key. The remote controller is not cordless but remains attached to the command board via a cable.
The anesthesia record keeper keyboard (K-ARKB) is attached to the frame with a cable. The record keeper keyboard features command board, record keeper function keys and letter and number keys (alphanumeric keys).
The bar code reader can be used to facilitate quick access to menus. The bar code reader is connected to the LCD display or to the record keeper keyboard. The manufacturing of the bar code reader has been discontinued, but the monitor software L-CANE05(A) still supports the use of it The parameter modules for the MRI monitor are built into the Compact Monitor frame during manufacturing. They cannot be removed during monitoring. Depending on the configuration the MRI Monitor features a different set of parameters.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the MRI Monitor with L-CANE05 or L-CANE05A software:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria or performance metrics for the device's functions (e.g., accuracy of heart rate, NIBP, SpO2 measurements). Instead, it states that the device has been "assessed against the standards below" and "thoroughly tested through validation and verification of specifications."
The primary performance improvement highlighted is related to its compatibility with the MRI environment:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| MRI compatibility line | Use in MRI Room up to the 300 Gauss line |
| RF interference reduction | Achieved by using a new RF shield, which eliminates the RF interference better than the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on sample size for any test sets, nor does it specify data provenance (country of origin, retrospective/prospective). The testing described is primarily non-clinical, focusing on compliance with various electrical, safety, and performance standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The testing described is technical and engineering-focused, not based on expert clinical evaluation of generated data.
4. Adjudication Method for the Test Set
This information is not provided. As there are no expert evaluations mentioned, there would be no need for an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study in the sense of an algorithm operating independently to produce a diagnosis or assessment was not performed or reported. This device is a patient monitor that displays physiological data for human (medical personnel) interpretation and decision-making. The "algorithm" here refers to the software controlling the physiological measurements and displays, which are validated against technical standards, not against clinical outcomes generated by AI.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is established through compliance with recognized electrical, safety, and performance standards. This involves testing the device against known inputs or controlled conditions to ensure its measurements are accurate and consistent with the specified standard requirements. For example, testing an ECG module against known electrical signals to verify heart rate accuracy.
8. Sample Size for the Training Set
The document does not describe a training set. This is a hardware and software integration project for a patient monitor, not a machine learning or artificial intelligence application that typically involves discrete training sets. The software (L-CANE05/A) is likely developed using traditional software engineering methodologies and verified against requirements and standards.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, there is no information on how its ground truth was established.
§ 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.