(70 days)
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status.
The CARESCAPE Monitor 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 Monitor 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.
The CARESCAPE Monitor B650 is not intended for use during MRI.
The CARESCAPE Monitor B650 is a multi-parameter patient monitor including both new and existing subsystems. The CARESCAPE Monitor B650 includes the monitor itself, the CARESCAPE Software Platform (also called ESP software) and the battery. The CARESCAPE Monitor B650 itself has 15 inch display (optional touch screen) with integrated keypad and a frame for parameter measurement modules. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader, and corded remote control), and physiological parameter measurement modules, which are existing subsystems. The CARESCAPE Monitor B650 communicates to a variety of existing OEM medical devices. The CARESCAPE Monitor B650 interfaces to a variety of other existing patient monitoring systems via a cabled or wireless network interface. The CARESCAPE Monitor B650 includes features and subsystems that are optional or configurable.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the CARESCAPE™ Monitor B650's performance or a table of its reported performance against such criteria. The submission states that the device "complies with voluntary standards" and that "The CARESCAPE Monitor B650 device is as safe and effective as the predicate devices." This suggests that the acceptance criteria are implicitly tied to demonstrating equivalence to the predicate devices and compliance with relevant standards, rather than specific performance metrics outlined in the document itself.
Therefore, I cannot generate a table with explicit acceptance criteria and corresponding performance numbers from this document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned.
- Data Provenance: Not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not mentioned. The document does not describe a test set or ground truth established by experts.
4. Adjudication Method for the Test Set
Not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement
No MRMC comparative effectiveness study was mentioned. The submission states, "The subject of this premarket submission, CARESCAPE™ Monitor B650 did not require clinical studies to support substantial equivalence."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a multi-parameter patient monitor that includes the EK-Pro Arrhythmia Detection Algorithm, EK-Pro V12. While the algorithm is a component, the submission focuses on the overall device's substantial equivalence and does not detail specific standalone algorithm performance studies. The "Summary of Non-Clinical Tests" includes "Performance testing (Verification)", but no details are provided about the nature or results of this testing specifically for the algorithm in a standalone context.
7. The Type of Ground Truth Used
Not mentioned. Given that no clinical studies were required, there is no mention of how ground truth (e.g., expert consensus, pathology, outcomes data) was established for performance evaluation.
8. The Sample Size for the Training Set
Not mentioned.
9. How the Ground Truth for the Training Set Was Established
Not mentioned. Given the device's substantial equivalence filing and the lack of explicit clinical studies, details about training set ground truth are not included. The algorithm (EK-Pro V12) is stated to employ the "same functional technology as the predicate device(s)" (EK-PRO ARRHYTHMIA DETECTION ALGORITHM, EK-Pro V11), implying that the underlying methodology and perhaps training data (if applicable to the original algorithm development) would be similar or derived from previous versions. However, no specific details are provided in this document.
§ 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.