(96 days)
The PM Series Patient Monitors including models PM-9000 Express and PM-8000 Express are intended to be used for monitoring, recording, and alarming of multiple physiological parameters in health care facilities by qualified health care professionals trained in the use of the equipment.
The physiological parameters that can be monitored by PM-9000 Express Patient Monitor are: ECG(3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Pulse Oxygen Saturation (SpO2), Temperature (TEMP), Invasive Blood Pressure(IBP), Pulse Rate(PR), Carbon Dioxide (CO2), and Anaesthetic Gases(AG).
The physiological parameters that can be monitored by PM-8000 Express Patient Monitor are: ECG(3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Pulse Oxygen Saturation (SpO2), Temperature (TEMP), Invasive Blood Pressure(IBP) and Pulse Rate(PR) , and Carbon Dioxide (CO2).
Their design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.
The target populations are human patients ranged from adult to neonate with the exception of the arrhythmia detection and ST Segment analysis, for which the farget populations are adult and pediatric only.
The PM Series Patient Monitors are not intended for use in a patient's home or residence, or when it has not been ordered by a physician.
The PM Series Patient Monitors including models PM-9000 Express are battery or line-powered patient monitors. The patient monitors acquire the physiological signals such as ECG, respiration (RESP), non-invasive blood pressure (NIBP), saturation of pulse oxygen (SpO2), temperature (TEMP), invasive pressure (IBP), carbon dioxide (CO) and anaesthetic gases (AG, PM-9000 Express only). These physiological signals are converted into digital data and processed. The monitors examine the data for alarm conditions and present them on the color TFT display. The monitors also provide advantageous operating control for the user. The optional built-in recorder, the optional CF memory card provides hard copies of all digital data and waveforms as well as tabular and graphic trend information, and storage the previous monitoring data information when power off accidentally.
The provided document is a 510(k) summary for the PM Series Patient Monitors. It details the device's intended use, comparison to predicate devices, and testing performed. However, it does not contain a specific table of acceptance criteria with reported device performance or a detailed study description with the requested information (sample sizes, ground truth provenance, expert qualifications, adjudication, MRMC, or standalone performance).
The document broadly states that "Bench testing has been conducted to validate and verify that the PM Series Patient Monitors...meet all design specifications and are substantially equivalent to the predicate devices." It also mentions compliance with various standards, including:
- ANSI/AAMI EC13-2002, "Cardiac monitors, heart rate meters, and alarms"
- AAMI EC57-98, "Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measurement Algorithms"
- ISO 21647-2005, "Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors"
- ISO9919, IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, IEC60601-2-27, IEC60601-2-30, and ISO14971.
Compliance with these standards implies that the device met the requirements outlined within those standards for various physiological parameters, but the specific acceptance criteria and performance data are not excerpted or summarized in this document.
Therefore, I cannot provide the detailed information requested in the format of the table below based on the given text.
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The document states that "Bench testing has been conducted to validate and verify that the PM Series Patient Monitors...meet all design specifications" and comply with various standards. However, the specific acceptance criteria (e.g., accuracy thresholds, sensitivity, specificity for arrhythmias) and the corresponding reported performance values are not detailed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text. The document mentions "Bench testing" and "clinical and bench testing" but does not specify the sample sizes used for the test set or the provenance of the data (country, retrospective/prospective).
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)
- Not available in the provided text. The document does not describe how ground truth was established for the test set, nor does it mention the number or qualifications of any experts involved in this process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text. There is no information regarding any adjudication methods for establishing ground truth or evaluating the test set.
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/Not available in the provided text. This device is a patient monitor, not an AI software intended to assist human readers in interpreting medical images or data. No MRMC study or AI assistance effect size is mentioned. The device directly measures and processes physiological signals.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially applicable. The PM Series Patient Monitors operate as standalone devices to acquire, process, and display physiological signals, and generate alarms. Their "algorithm only" performance would be inherent to their function to meet the standards they claim compliance with (e.g., accuracy of ECG analysis, ST-segment measurement, arrhythmia detection). However, a specific "standalone study" with detailed metrics is not described beyond the general statement of "bench testing."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in the provided text. Given the nature of a patient monitor, ground truth would typically come from reference standards for physiological measurements (e.g., calibrated devices for NIBP, temperature; manually verified ECG rhythm analysis by cardiologists for arrhythmia detection). However, the document does not specify the method for establishing ground truth.
8. The sample size for the training set
- Not applicable/Not available in the provided text. The document describes a patient monitor, not an AI/ML-based device that typically undergoes a distinct "training" phase with a large dataset. While the algorithms within the monitor might have been developed using data, a specific "training set" in the context of modern AI/ML development is not mentioned.
9. How the ground truth for the training set was established
- Not applicable/Not available in the provided text. For the reasons stated in point 8, this information is not provided.
§ 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.