(100 days)
The PM-7000 Patient Monitor is 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 the PM-7000 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).
Its 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 ranging from adult to neonate with the exception of the arrhythmia detection and ST Segment analysis, for which the target populations are adult and pediatric only.
The Monitor is not intended for use in a patient's home or residence, or when it has not been ordered by a physician.
The PM-7000 Patient Monitor is battery or line-powered patient monitor. The patient monitor 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 (CO2) and anaesthetic gases (AG). These physiological signals are converted into digital data and processed. The monitor examines the data for alarm conditions and presents them on the color TFT display. The monitor also provides 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-7000 Patient Monitor. It asserts the substantial equivalence of the PM-7000 to a predicate device, the PM-9000 Express Patient Monitor (K070791), rather than presenting a de novo study with specific acceptance criteria and performance data for the PM-7000 itself.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria. Instead, it relies on the predicate device's prior clearance and claims that the PM-7000, sharing the same parameters modules, measurement accessories, software/hardware, and main board, should perform equivalently.
However, I can extract the information that is present regarding the basis for equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of acceptance criteria or quantitative performance data for the PM-7000 Patient Monitor. It relies on the equivalence to its predicate device, the PM-9000 Express. The implicitly accepted performance is that the PM-7000 performs "as well as" the PM-9000 Express.
2. Sample Size for the Test Set and Data Provenance:
The document does not describe a specific test set or sample size used for a standalone study of the PM-7000's performance. The basis for equivalence is that the PM-7000 shares "identical parameters subsystems," "main board and host software," and "identical screen layout" with the predicate, PM-9000 Express. The "verification and validation" conducted were "caused by differences between PM-7000 and PM-9000 Express" and used "testing methods that have been cleared in PM-9000 Express (K070791)."
Therefore, information on data provenance (e.g., country of origin, retrospective/prospective) for a PM-7000 specific test set is not available in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document, as no specific test set or ground truth establishment for a de novo performance study of the PM-7000 is described.
4. Adjudication Method:
This information is not provided in the document, as no specific test set or ground truth establishment for a de novo performance study of the PM-7000 is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study is not mentioned in the document. The submission focuses on device equivalence, not on the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study for the PM-7000 is not explicitly described with specific results. The document states, "Parameter measurement performance and function specification of PM-7000 could be proved by the verification and validation of PM-9000 Express (K070791) because both are ensured by same modules and same software." This implies that the standalone performance is assumed to be equivalent to the predicate device due to shared internal components and software.
7. Type of Ground Truth Used:
The type of ground truth used to establish the performance of the PM-7000 is not specified within this document, as it defers to the "verification and validation" of the predicate PM-9000 Express. For vital sign monitoring devices, ground truth would typically come from reference standards and calibrated instruments.
8. Sample Size for the Training Set:
The document does not discuss a training set for the PM-7000. This is expected as the PM-7000 appears to be a direct physical and software equivalent to the predicate, PM-9000 Express, with minor changes in power supply, keyboard, and display screen. The functionality, including any algorithms (e.g., for arrhythmia detection), would have been developed and "trained" (if applicable) for the predicate device.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document, as no training set for the PM-7000 is discussed.
§ 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.