(254 days)
The Nihon Kohden Vital Sign Telemeters GZ-120P and GZ-130P are intended to monitor and transmit physiological data from a patient to a Nihon Kohden monitor via radiofrequency in the 802.11 band for continuous monitoring. Both GZ-120P and GZ-130P transmit electrocardiogram (ECG) and respiration data, and GZ-130P transmits blood oxygen saturation (SpO₂) in addition. The device may generate an audible and/or visible alarm when an arrhythmia exists, when a measured physiological rate falls outside preset limits, or when a technical error is detected. Furthermore, the devices can be configured for use as a temporary simple monitor to display the patient's vital signs on the device screens and generate alarms without transmitting the data to other Nihon Kohden monitor.
The devices are intended to be used by qualified medical personnel within a medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.
The Nihon Kohden Vital Sign Telemeter GZ-120P/GZ-130P is mainly used as a telemetry system within a medical facility. The device transmits patient's vital signs (ECG, SpO2*, respiration, pulse waveform) and alarm information via wireless LAN connection to the central monitoring station. The device can be configured to display the patient's vital signs on the screen and generate alarms for use as a temporary simple monitor. *SpO2 is for GZ-130P only.
The provided text describes the Nihon Kohden Vital Sign Telemeter GZ-120P/GZ-130P and details its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for a novel algorithm's performance. The document focuses on regulatory approval based on safety, essential performance, and equivalence to existing devices.
Therefore, many of the requested categories regarding algorithm-specific performance, ground truth, expert adjudication, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it describes a hardware device with monitoring capabilities, not an AI/algorithm-driven diagnostic/decision-support tool.
However, I can extract information related to the device's general performance and the types of tests conducted for its regulatory approval.
Here's the information based on your request, with an emphasis on what is available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the context of an algorithm's diagnostic accuracy. Instead, it refers to compliance with safety and performance standards.
Implicit "Acceptance Criteria" (Compliance with Standards) and "Reported Performance" (Validation of Compliance):
| Acceptance Criteria Category | Implicit Acceptance Criteria / Standard Compliance | Reported Device Performance / Validation |
|---|---|---|
| Electrical and Electromagnetic Safety | Compliance with relevant electrical and electromagnetic safety standards. | Testing to compliance standards for electrical and electromagnetic safety was performed. Standards include: ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2007, IEC 60601-1-2:2014. |
| Wireless Coexistence | Compliance with IEC 60601-1-2 (Edition 4, 2014) regarding immunity to proximity fields from radio frequency wireless communications equipment. | Wireless coexistence testing and evaluation was performed following IEC 60601-1-2 (Edition 4, 2014), and the device's immunity was validated. |
| Alarm Systems | Compliance with standards for alarm systems in medical electrical equipment. | Compliance with IEC 60601-1-8: 2006 + Am1: 2012 (General requirements, tests and guidance for alarm systems). The device may generate an audible and/or visible alarm when an arrhythmia exists, measured physiological rate falls outside preset limits, or a technical error is detected. |
| Electrocardiographic Monitoring Performance | Compliance with particular requirements for basic safety and essential performance of electrocardiographic monitoring equipment. | Compliance with IEC 60601-2-27: 2011 (Particular requirements for basic safety and essential performance of electrocardiographic monitoring equipment). The device transmits ECG data and its specifications of parameter measurements, ECG analysis and alarming function are "equivalent to the predicate device, BSM-6000." |
| Software Functionality | Software is verified and validated. | Includes software verification and validation test, software unit test, integration test, and system test. Traceability documented between all system specifications to validation test results. |
| Overall Safety and Effectiveness | Substantial equivalence to predicate devices and no new questions of safety or effectiveness. | Performance is "substantially equivalent" to predicate devices (Nihon Kohden BSM-6000 Series Bedside Monitor and Nihon Kohden ZS-940PA Transmitter), and "raises no safety or effectiveness issues." Differences were minor and did not raise questions regarding safety or efficacy. The device's "specifications of parameter measurements, ECG analysis and alarming function are equivalent to the predicate device." |
| Water Resistance | Meets applicable water resistance standards. | Water resistance specification is "better than that of the predicates, and the improved function is evaluated by safety standard." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "sample size" in terms of number of patients or physiological recordings for evaluating performance of an algorithm. The testing described is primarily related to engineering and regulatory compliance of the device itself (hardware, software, communication protocols). Therefore, data provenance is not discussed in terms of country of origin or retrospective/prospective collection as there isn't patient data being evaluated for a diagnostic algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This document describes the regulatory clearance for a vital sign telemeter, which transmits physiological data (ECG, respiration, SpO2) and generates alarms. It does not involve a diagnostic algorithm that requires expert-established ground truth for performance evaluation in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
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
Not applicable. The device is a monitor and telemeter, not an AI-assisted diagnostic tool that would involve human readers and their improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document does not describe a standalone algorithm performance study. The device itself performs functions like arrhythmia detection and alarm generation, but these are inherent to the monitor's functionality, not a separate "algorithm" requiring a standalone performance study. Its performance for these functions is indicated as being "equivalent to the predicate device."
7. The Type of Ground Truth Used
Not applicable in the context of an algorithm's diagnostic accuracy. The "ground truth" here would relate to the accuracy of the physiological measurements themselves against calibrated standards, and the proper functioning of alarms as per specifications and standards. This is implied by the "Test Summary" and "Standards compliance testing" sections.
8. The Sample Size for the Training Set
Not applicable. This device is not described as having an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated above.
§ 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.