(108 days)
The PM-1000F+ Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients.
The patient parameters that can be monitored with the PM-1000F+ Patient Monitor are ECG(3-lead or 5-lead selectable), Heart rate (HR), Pulse Rate (PR), Respiration rate (RESP), Non-invasive blood pressure (NIBP), Saturation of Pulse Oxygen (SpO2), Temperature (TEMP), Invasive Blood pressure (IBP), 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.
This monitor is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.
The PM-1000F+ Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
The PM-1000 F+ Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG, respiration (RES), non-invasive blood pressure (NIBP), saturation of pulse oxygen (SpO2), temperature (TEMP), invasive pressure (IBP), carbon dioxide (CO2) and anesthetic gases (AG). These physiological signals are converted into digital data and processed. The PM 1000F+ Patient Monitor examines the data for alarm conditions and presents them on the color TFT display. The Patient 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, a 510(k) summary, describes a patient monitor (PM-1000F+) and asserts its substantial equivalence to predicate devices. However, it does not explicitly detail a study conducted to demonstrate the device meets specific acceptance criteria with reported performance metrics. Instead, it describes compliance through testing against established standards and comparison to predicate devices.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific acceptance criteria (e.g., minimum accuracy percentages for parameters) and the PM-1000F+ Patient Monitor's reported performance against those criteria. Instead, it states:
"Testing was conducted to validate and verify that the PM-1000F+ Patient Monitor met all design specifications and was substantially equivalent to the predicate devices. Testing was performed to demonstrate compliance with the ANSI/AAMI standards EC13-2002, "Cardiac monitors, heart rate meters, and alarms." The PM-1000F+ has also been tested to assure compliance with the requirements of various published standards, including IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, IEC60601-2-27, IEC60601-2-30 and ISO14971."
This indicates that the acceptance criteria are implicitly defined by compliance with these international and national standards for medical electrical equipment and specific performance requirements for cardiac monitors. The "reported device performance" is summarized as having "met all design specifications" and being "substantially equivalent" to predicate devices, rather than detailed quantitative results.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical data for a study. The testing described is against established standards. Therefore, information about sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
As no clinical test set with associated ground truth established by experts is described, this information is not applicable and not provided.
4. Adjudication Method for the Test Set:
Since a clinical test set requiring expert adjudication is not described, this information is not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
The PM-1000F+ Patient Monitor is a vital signs monitor, not an AI-assisted diagnostic device that would involve human "readers" or an AI component designed to improve human interpretation. Therefore, an MRMC comparative effectiveness study with AI assistance is not applicable and not mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The PM-1000F+ is a patient monitor that directly measures physiological signals and processes them for display and alarm generation. It doesn't present an "algorithm-only" performance scenario in the way an AI diagnostic tool might. The device's performance is tested against established standards for accuracy and reliability of its measurements (ECG, NIBP, SpO2, etc.). While its processing of signals represents an "algorithm," the document doesn't break down testing into a standalone algorithm performance versus human-in-the-loop in the context of a typical AI submission. Its "standalone" performance is implicitly covered by the compliance testing to the listed standards.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
For a physiological monitor, the "ground truth" for its measurements (e.g., heart rate, blood pressure, oxygen saturation) is typically established by reference methods or simulators that are themselves validated and considered accurate. For example, during NIBP testing, a manometer might be considered the ground truth. The document broadly states "Testing was conducted to validate and verify that the PM-1000F+ Patient Monitor met all design specifications," implying that the measurements taken by the device were compared against such established reference standards or methods. However, specific details of the ground truth for each parameter are not explicitly described beyond compliance with relevant standards.
8. The Sample Size for the Training Set:
The PM-1000F+ Patient Monitor is a traditional medical device, not an AI/Machine Learning device that undergoes a "training" phase with a dataset. Therefore, the concept of a "training set" is not applicable and not mentioned.
9. How the Ground Truth for the Training Set Was Established:
Since there is no "training set," this information is not applicable.
In summary:
The provided 510(k) summary focuses on demonstrating substantial equivalence through adherence to recognized performance and safety standards for patient monitors and comparison to predicate devices, rather than detailing a clinical study with specific acceptance criteria, sample sizes, and expert adjudication as might be found in an AI/diagnostic device submission.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).