(196 days)
The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources.
The CARESCAPE B650 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Contraindications for using CARESCAPE B650:
The CARESCAPE B650 is not intended for use in a controlled MR environment.
CARESCAPE B650 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650 includes the monitor with built-in CPU, power unit, a 15 inch touch display, the CARESCAPE Software and the battery. CARESCAPE B650 is equipped with two module slots where patient data acquisition modules (E-Module type) can be connected to perform patient monitoring. CARESCAPE B650 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition devices. In addition to the ePort interface the PDM module can be also connected directly to the CARESCAPE B650 via special slide mount connector which is in the back of the monitor. The CARESCAPE B650 includes features and subsystems that are optional or configurable.
The provided text is a 510(k) Summary for the GE Healthcare CARESCAPE B650 patient monitor. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of acceptance criteria and device performance. Therefore, the information requested in your prompt is largely not available within this document.
Here's a breakdown of what can and cannot be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding reported device performance values in the format you requested. It states: "Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B650, demonstrating the design meets the specifications." This is a general statement about testing without specific criteria or performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "Bench testing related to software, hardware and performance," but does not detail the nature of the test sets, their size, or their origin.
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)
This information is not provided. As this is a 510(k) submission for a patient monitor, the primary evidence relies on engineering and performance testing against established standards, not typically on expert consensus for "ground truth" in the way it might be for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done, and it is not applicable to this submission. The device is a patient monitor, not an AI-assisted diagnostic tool that would involve human readers. The document explicitly states: "The subject of this premarket submission, CARESCAPE B650 did not require clinical studies to support substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "Bench testing related to software, hardware and performance" and "Software testing included software design, development, verification, validation and traceability." This implies standalone testing of the device's algorithms and functionality. However, specific details about the results of such standalone performance are not provided in a quantifiable manner against acceptance criteria.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (a multi-parameter patient monitor), "ground truth" would likely be established through:
- Reference measurement devices/standards: For parameters like ECG, blood pressure, oxygen saturation, temperature, etc., the device's measurements would be compared against validated reference devices or established physical standards.
- Simulated physiological signals: For arrhythmia detection, the device would be tested with simulated ECG waveforms containing known arrhythmias.
However, the specific types of "ground truth" used are not explicitly elaborated beyond "bench testing" and "applicable consensus standards."
8. The sample size for the training set
This information is not provided and is generally not applicable in the context of a patient monitor's 510(k) submission unless specific machine learning algorithms requiring training data were a novel aspect of the submission, which is not indicated here. The document describes modifications to software and hardware, implying updates to existing functionalities rather than the introduction of new, data-trained AI models.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons stated in point 8.
§ 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.