(31 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 the PM-8000 Patient Monitor are: ECG (3-lead or 5-lead selectable), Heart Rate derived from selected source (SPO2, ECG), Respiration Rate (derived from ECG), Non-Invasive Blood Pressure (NIBP), Saturation of Pulse Oxygen (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 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-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 line-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.
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for a PM-8000 Patient Monitor, discussing its substantial equivalence to a predicate device and outlining general testing performed, but it lacks the detailed information you requested regarding acceptance criteria and performance metrics.
The provided text focuses on:
- Device identification and classification
- Comparison to a predicate device
- Intended use
- A brief "Test Summary" indicating general lab testing (Risk Analysis, Electrical Safety Testing, Function and Performance Testing, Environmental Testing, Clinical Testing) was conducted to ensure design specifications were met and substantial equivalence.
- A conclusion that the device is as safe and effective as the predicate device based on clinical and laboratory testing.
It does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or related effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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).