(101 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 prehospital 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 text is a 510(k) summary for the GE DASH 3000/4000 Patient Monitor. It does not contain specific acceptance criteria or a detailed study section with reported device performance metrics against those criteria.
Instead, it outlines the device's intended use, technological equivalence to predicate devices, and a high-level summary of tests and standards it complies with. It concludes with a general statement about safety and effectiveness.
Therefore, I cannot populate the requested table or provide detailed information for many of the questions based on the provided text.
Here is what can be inferred or stated based on the text, with limitations noted:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from regulatory standard compliance and general claims) | Reported Device Performance (as stated in the document) |
|---|---|
| Compliance with ANSVAAMI EC13 (ECG) | Device "complies with" standard. |
| Compliance with ANSVAAMI SP10:1992 (BP Sphygmomanometer) | Device "complies with" standard. |
| Compliance with IEC 60601-1 (General medical electrical equipment safety) | Device "complies with" standard. |
| Compliance with IEC 60601-1-1 (Safety requirements for medical electrical systems) | Device "complies with" standard. |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Device "complies with" standard. |
| Compliance with IEC 60601-2-27 (ECG safety) | Device "complies with" standard. |
| Compliance with IEC 601-2-30 (Automated noninvasive sphygmomanometers) | Device "complies with" standard. |
| Compliance with IEC 601-2-34 (Invasive blood pressure monitoring) | Device "complies with" standard. |
| Compliance with UL 2601 (Medical electrical equipment safety) | Device "complies with" standard. |
| Safety equivalent to predicate devices | "is as safe as the predicate devices." |
| Effectiveness equivalent to predicate devices | "is as effective as the predicate devices." |
| Performance equivalent to predicate devices | "performs as well as the predicate devices." |
Limitations: The document only states compliance with these standards and general equivalence. It does not provide specific numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity, or specific error ranges) for each physiological parameter that would typically define "acceptance criteria" in a detailed study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document mentions "Software and hardware testing," "Safety testing," "Environmental testing," and "Final validation" but gives no details on sample sizes, types of data (e.g., clinical, simulated), or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This device is a patient monitor, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for a patient monitor would typically be established by comparing its measurements to established reference standards or other calibrated devices. The document does not detail this process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically used in studies involving human interpretation (e.g., radiologists) where there might be disagreement in assessments. For a patient monitor, performance is usually assessed against objective, measurable standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a patient monitor, not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study comparing human performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided in the context of an "algorithm only" AI device. The device is a physiological monitor; its performance is inherently standalone in terms of measuring vital signs. The summary describes general testing and compliance with standards, implying the device's functions work as intended, but doesn't detail standalone algorithmic performance in the way it would for an AI-driven image analysis tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified, but inferred to be reference standards or calibrated measurement devices. For physiological monitors, ground truth for parameters like ECG, blood pressure, temperature, etc., is typically established by using highly accurate and calibrated reference instruments or simulated physiological signals that mimic real-world conditions. The document does not describe the specific ground truth methods.
8. The sample size for the training set
- Not applicable. This device precedes the era where "training sets" for deep learning models were a standard part of medical device submissions. It appears to be a traditional hardware and software medical device, not an AI/machine learning product. Therefore, there is no "training set" in the modern sense.
9. How the ground truth for the training set was established
- Not applicable. As a traditional device, there is no "training set" (as understood in machine learning) or associated ground truth establishment for such a set.
§ 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.