(198 days)
The Dash 3000/4000 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and pre-hospital emergency response.
Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, and anesthetic agents as summarized in the operator's manual.
The Dash 3000/4000 Patient Monitor is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care.
This information can be displayed, trended, stored, and printed.
The Dash 3000/4000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.
The Dash 3000/4000 Patient Monitor is a device that is designed to be used to monitor, display, and print a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, impedance respiration, end-tidal carbon dioxide, oxygen, nitrous oxide and anesthetic agents. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL). Additionally, the network interface allows for the display and transfer of network available patient data.
The provided document refers to the K020290 submission for the GE Medical Systems Information Technologies Dash 3000/4000 Patient Monitor. This submission is a 510(k) premarket notification, which means the device is seeking substantial equivalence to a predicate device rather than presenting novel acceptance criteria or a detailed clinical study for efficacy.
Therefore, the document does NOT contain the specific information requested in the prompt regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods, or ground truth details for a test set.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Details of a standalone algorithm performance study.
- Sample size and ground truth establishment for a training set.
Instead, the document focuses on the regulatory aspects of a 510(k) submission, confirming the device's intended use, classification, and that it "employs the same functional scientific technology as its predicate devices."
The "Test Summary" section lists quality assurance measures applied to the development, which are general engineering and quality management practices, not specific clinical performance studies with acceptance criteria as typically understood for AI/ML devices. These measures include:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing
- Safety testing
- Environmental testing
The conclusion states: "The results of these measurements demonstrated that the Dash 3000/4000 Patient Monitor are as safe, as effective, and perform as well as the predicate device." This is a statement of substantial equivalence, not a report of meeting specific numerical performance criteria from a clinical study.
In summary, the provided document does not contain the detailed study results and acceptance criteria as requested because it is a 510(k) summary for a patient monitor, which relies on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical performance data against predefined acceptance criteria in the manner expected for an AI/ML device.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.