(29 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, non-invasive 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 GE Medical Systems Information Technologies Dash 3000/4000 Patient Monitor is a physiological patient monitor designed to monitor, display, and print a patient's basic physiological parameters. These parameters include electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, impedance respiration, end-tidal carbon dioxide, oxygen, nitrous oxide, and anesthetic agents. The device also offers features like arrhythmia detection, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12-lead ECG analysis (12SL).
This submission describes the acceptance criteria and study used to demonstrate the substantial equivalence of the Dash 3000/4000 Patient Monitor to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list specific numerical acceptance criteria for each physiological parameter monitored by the Dash 3000/4000 Patient Monitor, nor does it provide detailed reported device performance values in a quantitative table.
Instead, the submission outlines a general approach to compliance and testing. The "Test Summary" section states:
"The Dash 3000/4000 Patient Monitor complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:
- Requirements specification review
- Code inspections
- Software and hardware testing
- Safety testing
- Environmental testing
- Final validation"
The "Conclusion" then states:
"The results of these measurements demonstrated that the Dash 3000/4000 Patient Monitor is as safe, as effective, and performs as well as the predicate devices."
This implies that the acceptance criteria were based on adherence to relevant voluntary standards and that the device's performance was found to be comparable to that of the predicate devices for all specified physiological parameters. Without "Section 9" or further detailed test reports, specific numerical performance figures and acceptance thresholds cannot be extracted from this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the test set. It mentions "software and hardware testing," "safety testing," and "environmental testing," but does not provide details about the number of patients, data points, or scenarios included in these tests.
The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned in the summary. The studies appear to be internal verification and validation tests rather than clinical trials with external data sources.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided summary does not mention the use of experts to establish ground truth for any specific physiological parameter. The testing appears to be focused on technical performance against established standards and predicate device comparisons rather than requiring expert adjudication of clinical outcomes or interpretations.
4. Adjudication Method for the Test Set
Since the summary does not indicate the involvement of experts for establishing ground truth, there is no adjudication method mentioned (e.g., 2+1, 3+1). The testing described likely relied on instrumental measurements and technical specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The summary does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is a physiological patient monitor, and the described testing focuses on its technical performance and compliance with standards, not on human reader interpretation accuracy or the effect of AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The summary does not explicitly describe a standalone performance study in terms of "algorithm only without human-in-the-loop performance." However, the "Test Summary" detailing "software and hardware testing" and "final validation" implies that the device's functionality was evaluated in a standalone manner to ensure it meets requirements and performs as intended. The listed physiological parameters are measured and displayed by the device itself, suggesting an inherent standalone performance evaluation against established reference methods or predicate devices.
7. Type of Ground Truth Used
The type of ground truth used for the testing highlighted in the summary would be based on:
- Voluntary standards: Compliance with recognized industry and regulatory standards (as mentioned in Section 9, although not provided).
- Predicate device comparison: Performance being "as safe, as effective, and performs as well as the predicate devices," indicating that the predicate device's performance serves as a benchmark for comparison.
- Technical specifications and requirements: The device's performance against its own "requirements specification."
- Instrumental measurements: For parameters like ECG, blood pressure, temperature, etc., the "ground truth" would be derived from calibrated reference instruments or established measurement methodologies.
8. Sample Size for the Training Set
The Dash 3000/4000 Patient Monitor is presented as a physiological monitoring device, not a machine learning or AI-driven diagnostic algorithm that typically relies on a distinct "training set." Therefore, the concept of a "training set sample size" as understood in AI/ML contexts does not apply to the information provided in this 510(k) summary. The device's functionality is based on established signal processing and measurement techniques, not on a data-driven learning model requiring traditional training data.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" is not applicable to the type of device and information provided in this 510(k) summary. Therefore, how ground truth for a training set was established is not relevant or described.
§ 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.