(167 days)
The PM-9000 Express Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PM-9000 Express 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-9000 Express Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(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.
The PM-9000 Express 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-9000 Express 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-9000 Express Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires 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 PM-9000 Express 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 text describes a 510(k) premarket notification for the PM-9000 Express Patient Monitor, comparing it to predicate devices. However, it does not contain a table of acceptance criteria with reported device performance or information about a specific study designed to prove the device meets said acceptance criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through compliance with various industry standards and general testing.
Here's an attempt to extract relevant information based on your request, noting where information is explicitly missing:
Acceptance Criteria and Study Information for PM-9000 Express Patient Monitor
The provided 510(k) summary does not include a direct table of acceptance criteria with corresponding device performance metrics. Instead, it asserts compliance with various national and international standards as evidence of safety and effectiveness, and substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
No specific table of acceptance criteria with corresponding performance metrics (e.g., sensitivity, specificity, accuracy) is presented in the provided document. The device broadly claims compliance with established standards for various physiological measurements.
However, the document states:
- "all these parameters of the pending device and the predicate device comply with ANSI/AAMI standards, IEC standards, EN standards and ISO standards."
- "The PM-9000 Express Patient Monitor provides two kinds of Temperature accessories applicable. YSI series and MR series. Both of them have same measurement range and accuracy, and both comply with EN12470-4."
- "For CO2, both the pending device and the predicate device with EN864, ISO9918; for AQ, both the pending device and the predicate device comply with EN864, ISO11196, EN12598, EN7767."
- "Testing of the non-invasive blood pressure portion of the system was conducted according to the requirements outlined in the ANSI/AAMI Standards SP10 'Electronic automated sphygmomanometers.'"
Based on these statements, the "acceptance criteria" are implied to be the performance and safety requirements specified by these standards. The "reported device performance" is implicitly that the device meets these standards.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing described is "Laboratory testing" and does not specify a "test set" in terms of patient data samples, nor does it mention data provenance (country, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The summary focuses on engineering and regulatory compliance testing rather than clinical validation involving expert adjudicated ground truth.
4. Adjudication Method
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided in the document. The document describes laboratory testing and compliance with standards, not a comparative effectiveness study involving human readers with and without AI assistance. The device itself is a patient monitor, not explicitly an AI-driven diagnostic tool in the context of this summary.
6. Standalone (Algorithm Only) Performance
The device is a "Patient Monitor" and its performance is described in the context of its overall function of acquiring, processing, and displaying physiological signals. The testing described focuses on the device as a whole and its compliance with relevant standards for patient monitoring equipment. It does not isolate an "algorithm only" performance separate from the integrated device.
7. Type of Ground Truth Used
The "ground truth" implicitly used for the testing described are the specifications and requirements defined by the various industry standards (e.g., ANSI/AAMI, IEC, EN, ISO). For instance, NIBP testing was against the requirements of ANSI/AAMI SP10. This would typically involve reference measurement techniques defined within those standards. There is no mention of pathology, outcomes data, or expert consensus in a clinical validation sense.
8. Sample Size for the Training Set
This information is not provided in the document. The document does not describe the use of machine learning algorithms requiring a distinct "training set" in the context of AI.
9. How Ground Truth for the Training Set Was Established
This information is not provided as there is no mention of a "training set" or AI-specific development.
Summary of Testing:
The PM-9000 Express Patient Monitor underwent:
- Laboratory testing to validate and verify design specifications.
- Environmental testing as identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document.
- Compliance testing against:
- ANSI/AAMI standards (EC13-2002 for Cardiac monitors; SP10 for NIBP).
- IEC standards (IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, IEC60601-2-27, IEC60601-2-30).
- EN standards (EN864, EN865, EN12470-4 for Temperature, EN11196, EN12598, EN7767 for AG).
- ISO standards (ISO14971 for risk management, ISO9918 for CO2, ISO11196 for AG).
- Hazard analysis of the system and its software, with subsequent testing to validate overall operation.
- Safety testing performed by third-party agencies.
The conclusion drawn from this testing was that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate device."
§ 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).