(181 days)
The PM-8000 Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PM-8000 Patient Monitor has many features and functions, yet is easy to use through an integrated keypad, knob and an intuitive menu system.
The patient parameters that can be monitored by PM-8000 Patient Monitor are: ECG (3-lead or 5-lead selectable). Heart Rate derived from selected source (SP02, ECG), Respiration Rate (derived from ECG), Non-invasive blood pressure (NBP), Oxygen Saturation of the blood (SpO2), Temperature (TEMP) and invasive pressure (IBP). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.
The PM-8000 Patient Monitor is intended for us in health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.
The PM-8000 Patient Monitor is not recommended for use in a patient's home or residence, during the patient transport, or when it has not been ordered by a physician.
The PM-8000 Patient Monitor is a battery or linc-powered patient monitor. The PM-8000 Patient Monitor acquires the physiological signals such as ECG, respiration (RESP), non-invasive blood pressure (NIBP), Saturation of Pulse Oxygen (SpO2), temperature (TEMP) and invasive pressure (IBP). These physiological signals are converted into digital data and processed. The PM-8000 Patient Monitor examines the data for alarm conditions and presents them on the color TFT display.
The optional built-in recorder provides hard copies of all digital data and waveforms as well as Tabular and Graphic Trend Information.
The provided 510(k) summary for the PM-8000 Patient Monitor describes its safety and effectiveness relative to a predicate device, the Datascope Passport 2TM Vital Signs Monitor. However, it does not contain specific acceptance criteria for individual performance metrics (like accuracy, sensitivity, specificity for each physiological parameter) nor detailed study results demonstrating how the device meets such criteria in terms of quantitative performance.
Instead, the submission focuses on:
- Substantial Equivalence: Arguing the PM-8000 is substantially equivalent to a combination of existing systems, particularly the Datascope Passport 2TM, despite one minor difference in NIBP measurement range, which is stated to still meet the SP-10 standard.
- Compliance with Standards: Stating that laboratory testing was conducted to ensure compliance with several industry standards (e.g., ANSI/AAMI EC13-2002 for cardiac monitors, ANSI/AAMI SP10 for NIBP, and Masimo's testing protocol for pulse oximetry).
- Risk Analysis: Discussing potential risks (electrical shock, misdiagnosis due to inaccurate data or alarms) and how they are addressed.
Therefore, many of the specific questions about acceptance criteria implementation and detailed study design cannot be fully answered from this document. I will provide information based on what is present and explicitly state when information is not available.
Acceptance Criteria and Device Performance
The document does not provide a table of explicit acceptance criteria for specific performance metrics (e.g., "ECG HR accuracy must be +/- 5 bpm"). Instead, it states that the device was tested to meet design specifications and comply with relevant industry standards.
Reported Device Performance:
- For Non-Invasive Blood Pressure (NIBP), the document states: "the specifications of the PM-8000 patient monitor are met the SP-10 standard."
- For Pulse Oximetry (SpO2), "Testing of the pulse oximetry portion of the system was conducted according to Masimo's testing protocol." (This implies it meets the standards relevant to Masimo's licensed technology, which is used in the predicate).
- For Cardiac Monitors (ECG, Heart Rate, Respiration Rate), "Additional testing was performed to demonstrate compliance with the ANSI/AAMI standards EC13-2002, 'Cardiac monitors, heart rate meters, and alarms'."
| Parameter Type | Acceptance Criteria (as stated or implied) | Reported Device Performance |
|---|---|---|
| Overall Device | Met all design specifications and demonstrated substantial equivalence to the predicate device. | "Demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device." |
| NIBP | Compliance with ANSI/AAMI Standards SP10 "Electronic automated sphygmomanometers." | "The specifications of the PM-8000 patient monitor are met the SP-10 standard." |
| Pulse Oximetry | Compliance with Masimo's testing protocol (licensed technology, similar to predicate). | "Testing of the pulse oximetry portion of the system was conducted according to Masimo's testing protocol." |
| Cardiac Monitoring | Compliance with ANSI/AAMI standards EC13-2002, "Cardiac monitors, heart rate meters, and alarms." | "Testing was performed to demonstrate compliance with the ANSI/AAMI standards EC13-2002, 'Cardiac monitors, heart rate meters, and alarms'." |
| Environmental/Safety | Compliance with FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document and various other safety standards (e.g., EN865-1997, IEC 601-1 series). | Laboratory testing conducted to validate and verify compliance with all identified environmental testing, hazard analysis, and external safety standards. |
Study Details
-
Sample size used for the test set and the data provenance:
- The document mentions "Laboratory testing" and "environmental testing" and "testing of the non-invasive blood pressure portion" and "testing of the pulse oximetry portion." However, no specific sample sizes (e.g., number of patients, number of measurements) for any of these tests are provided.
- Data Provenance: Not specified. Given the nature of performance testing against standards, these were likely conducted in a controlled laboratory environment rather than on clinical patient data with specific geographic origins.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. For medical device performance testing against standards (like NIBP accuracy against a reference manometer, or ECG accuracy against a calibrated signal generator), ground truth is established by highly accurate reference instruments or simulated signals, not typically by expert human interpretation.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. This type of adjudication is typically used for subjective image interpretation or complex clinical endpoint studies. Device performance testing against standards relies on objective measurements.
-
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:
- No, an MRMC study was not done. This device is a patient monitor, not an AI-assisted diagnostic tool for human readers. Its primary function is to acquire, process, and display physiological signals, and generate alarms, not to provide interpretations that human readers would then review or be assisted by.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, standalone performance testing against standards was performed for each parameter. The testing described (e.g., compliance with SP10 for NIBP, EC13-2002 for cardiac monitors) represents the inherent performance of the device's algorithms and hardware in measuring and processing physiological signals, independent of human interaction beyond operating the device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Reference Standards and Calibrated Instruments: The ground truth for this type of device performance testing would be established using validated reference measurement systems and calibrated devices. For example:
- NIBP: Likely compared against a validated reference method (e.g., an intra-arterial catheter or a highly accurate reference sphygmomanometer) as required by ANSI/AAMI SP10.
- ECG/Heart Rate: Likely compared against precisely generated electrical signals with known heart rates and waveforms from an ECG simulator.
- SpO2: Likely involved controlled hypoxia studies or comparison to co-oximetry in accordance with Masimo's protocols (which typically involve human subjects).
- Reference Standards and Calibrated Instruments: The ground truth for this type of device performance testing would be established using validated reference measurement systems and calibrated devices. For example:
-
The sample size for the training set:
- Not applicable / Not specified. This device predates widespread machine learning/AI for core physiological parameter measurement. While it involves signal processing algorithms, these are typically rule-based or classic digital signal processing techniques that do not require "training sets" in the modern machine learning sense. The "design specifications" and "hazard analysis" mentioned are part of its development, but not "training."
-
How the ground truth for the training set was established:
- Not applicable / Not specified. As noted above, typical machine learning training sets with associated ground truth are not relevant to the described development and testing for this type of patient monitor in 2003.
§ 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).