(113 days)
The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.
The proposed Monitor B40V2 is a multi-parameter patient monitor that is developed based on the predicate Monitor B40V1 (K120598) platform. The proposed Monitor B40V2 provides additional support for optional modules (E-Entropy module (K061907) and CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) compared with predicate Monitor B40V1 (K120598). The proposed Monitor B40V2 is also compatible with CARESCAPE Respiratory modules (E-sCOV and EsCAiOV)(K123195) but with disabled spirometry function. The proposed Monitor B40V2 utilizes the existing 12 inch LCD display with an integrated keypad and a pre-configuration patient parameter measurement module. The proposed Monitor B40V2 will continue to interface with the optional E-MiniC (K052582) and Thermal Recorder with an extension rack. As with the predicate Monitor B40V1, the proposed Monitor B40V2 includes features and subsystems that are optional or configurable. The proposed Monitor B40V2 interfaces to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40V1, the proposed Monitor B40V2 has a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.
This document describes the GE Monitor B40V2, a multi-parameter patient monitor. The primary focus of the provided text regarding acceptance criteria and studies is on the SpO2 accuracy performance for the neonatal patient population.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document specifically mentions an SpO2 accuracy performance study for the neonatal population. However, it does not explicitly state numerical acceptance criteria (e.g., specific accuracy ranges or statistical thresholds) within the provided text. It only reports that the study "demonstrated SpO2 accuracy performance."
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance |
|---|---|
| (Specific SpO2 accuracy threshold for neonates, e.g., ±X% saturation) | SpO2 accuracy performance of the TruSignal V2 technology was demonstrated on the neonate population. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document only mentions "Neonatal patient population" for the clinical study.
- Data Provenance: Not explicitly stated in the provided text regarding country of origin. The study was a "Clinical study of the GE SpO2 TruSignalV2 on Neonatal patient population." It is described as a prospective study since it was a "clinical study" performed "in accordance to ISO 14155-1, ISO14155-2, ISO9919 and FDA Guidance."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not explicitly stated in the provided text.
4. Adjudication Method for the Test Set
Not explicitly stated in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study described is a clinical study for SpO2 accuracy in neonates, not a comparison of human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The clinical study was performed to demonstrate the "SpO2 accuracy performance of the TruSignal V2 technology on the neonate population," which implies an evaluation of the algorithm's performance independent of human interpretation.
7. The Type of Ground Truth Used
The ground truth for the SpO2 accuracy study would typically be established by a co-oximeter or a reference device known to precisely measure arterial oxygen saturation (SaO2) from blood samples. While not explicitly stated as "co-oximetry," clinical studies for SpO2 accuracy universally rely on such reference measurements.
8. The Sample Size for the Training Set
Not applicable/Not stated. The document refers to a clinical study for performance demonstration, not the training of an AI algorithm. The device primarily consists of a "TruSignal V2 algorithm" which is likely a fixed, developed algorithm, not one that undergoes continuous training in the context described.
9. How the Ground Truth for the Training Set was Established
Not applicable/Not stated. As above, this document describes performance testing of a developed algorithm, not the training phase.
§ 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.