(188 days)
The DINAMAP® ProCare Series Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature. The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/ surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.
The DINAMAP ProCare Series Monitor is a prescription device intended for use only by health care professionals. Four configurations of the monitor-all with integrated printer-will offer the following vital signs parameters:
- DPC XXX: Non-Invasive Blood Pressure and Pulse Rate ●
- DPC XXX: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry o
- . DPC XXX: Non-invasive Blood Pressure and Pulse Rate, Temperature
- DPC XXX: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry ● and Temperature.
This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery.
The GE Medical Systems Information Technologies DINAMAP® ProCare Series Monitor relies on substantial equivalence to predicate devices rather than a standalone study demonstrating specific acceptance criteria. This means the device is deemed safe and effective because it operates with the same underlying technology and performs comparably to devices already legally marketed.
Here's an breakdown based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria or quantifiable performance metrics for the DINAMAP® ProCare Series Monitor in a specific table. Instead, it relies on the "substantial equivalence" of its underlying technologies to predicate devices. The study proving the device meets "acceptance criteria" (implicitly, the performance of the predicate devices) is primarily based on:
| Parameter/Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance | Study Type to Demonstrate Equivalence |
|---|---|---|---|
| Non-Invasive Blood Pressure (NIBP) | Performance equivalent to DINAMAP® Pro Series 100-400 or Welch Allyn Vital Signs Monitor. Meets ANSI/AAMI SP10 standard. | NIBP oscillometric algorithm wholly implemented from the DINAMAP Pro Series 100-400 or an NIBP auscultatory algorithm tested according to the ANSI/AAMI SP10 standard. | Bench studies (AAMI/ANSI SP10) |
| Pulse Oximetry (SpO2) | Performance equivalent to Masimo SET Pulse Oximeter. | Wholly implemented Masimo SpO2 technology. | Substantial Equivalence to K992238 |
| Temperature | Performance equivalent to Alaris Medical System. | Wholly implemented Alaris thermometry technology. | Substantial Equivalence to K955846 |
| Overall Functionality (Mechanical, Electrical Safety, EMC, Battery) | Meets established safety and performance standards for medical devices. | Demonstrated through various bench studies: Mechanical and Environmental, Electromagnetic Compatibility, Battery Power, Electrical Safety. | Bench studies |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a "test set" in the context of human patient data with a specific sample size. The testing primarily involved bench studies to confirm adherence to engineering and performance standards (e.g., AAMI/ANSI SP10, mechanical, electrical safety).
There is no information provided on the country of origin of data or whether the data was retrospective or prospective as no human patient data test set is described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since there isn't a described "test set" and a process of establishing ground truth with experts in the human data sense, this information is not applicable and therefore not provided in the document.
4. Adjudication Method for the Test Set
As there is no described test set involving human data and expert review, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The device's approval is based on substantial equivalence to predicate devices and bench testing, not on human reader performance improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The NIBP algorithm is stated to be "wholly implemented from the DINAMAP Pro Series 100-400 Monitor or an NIBP auscultatory algorithm tested according to the ANSI/AAMI SP10 standard." The Masimo SpO2 and Alaris thermometry technologies are also "wholly implemented." This indicates that the algorithms themselves were likely evaluated in a standalone manner as part of the predicate device's original testing and by adherence to standards like ANSI/AAMI SP10 for NIBP. However, a dedicated standalone study for this specific device with performance metrics is not detailed beyond the statement of implementation and standard adherence.
7. Type of Ground Truth Used
The "ground truth" for the performance of the NIBP algorithm, for example, would have been established historically for the predicate devices or by the ANSI/AAMI SP10 standard, which specifies requirements for accuracy of non-invasive blood pressure monitors. For SpO2 and temperature, the "ground truth" would be inherent in the established performance and accuracy of the "wholly implemented" Masimo and Alaris technologies, respectively, likely validated by their own regulatory submissions. This would primarily be objective measurements against established reference methods or standards, rather than expert consensus, pathology, or outcomes data in the context of this submission.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning. The device relies on established algorithms from predicate devices (DINAMAP Pro Series 100-400 for NIBP, Masimo for SpO2, Alaris for Temperature). Therefore, information on a training set size is not applicable.
9. How the Ground Truth for the Training Set Was Established
Since there is no described "training set" for a new machine learning algorithm, how its ground truth was established is not applicable. The ground truth for the underlying algorithms would have been established during the development and validation of the predicate devices or the implemented technologies (Masimo, Alaris) using methods appropriate for physiological measurements (e.g., comparison to invasive gold standards for BP, co-oximetry for SpO2, calibrated thermometers for temperature).
§ 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).