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CARESCAPE ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. CARESCAPE ONE is indicated for the monitoring of hemodynamic and respiratory physiological parameters. When the CARESCAPE ONE is operated as a standalone multi-parameter physiological patient monitor, it provides the following physiological parameters: - · ECG (heart rate, ST segment, and arrhythmia detection) - · Pulse oximetry (pulse rate, functional oxygen saturation [SpO2]) - · Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures) - · Invasive pressure (pulse rate and systolic, diastolic, and mean pressures) - · Temperature - · Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate) - · Impedance respiration When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, it provides the following physiological parameters to the host monitor: - · ECG (heart rate, ST segment, and arrhythmia detection) - · Pulse oximetry (pulse rate, function [SpO2], and total hemoglobin concentration [SpHB]] - · Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures) - · Invasive pressure (pulse rate and systolic, diastolic, and mean pressures) - · Regional oxygen saturation (rSO2) - · Temperature - · Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate) - · Impedance respiration When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, visual and audible alarms, user controls, and user interface are provided on the compatible host monitor and not on CARESCAPE ONE. CARESCAPE ONE is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. Regional oxygen saturation (rSO2) is an adjunct parameter for nonitoring of cerebral/somatic regional oximetry of blood in the brain or other tissue beneath the sensor. It is intended to be used on patients greater than 40 kg (88 lbs) at risk for reduced-flow or no-flow ischemic states. CARESCAPE ONE is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility. Contraindications for using CARESCAPE ONE: The CARESCAPE ONE is not intended for use within a controlled MR environment.

CARESCAPE ONE belongs to the CARESCAPE patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only the parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular vital sign, currently there are ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, CO2, and rSO2 (rSO2 monitoring is only supported when CARESCAPE ONE is operating as an acquisition device. rSO2 values are not displayed on CARESCAPE ONE). The only exception is the Non-Invasive Blood Pressure (NIBP) measurement which does not require a separate ACM since the capability to measure NIBP is built-in to the CARESCAPE ONE monitor itself. CARESCAPE ONE provides the users the acquired display values, waveforms, alarms and status messages in compact footprint monitor that runs on an internal battery as well as AC power when connected to the docking station. When connected to a compatible host monitor, CARESCAPE ONE operates as an acquisition device. In this mode, CARESCAPE ONE screen and user interface is effectively disabled and it transmits data received form the Active Cable Modules to the host monitor, which is responsible for managing clinical configuration settings, and displaying values, waveforms, alarms, and status messages.

The provided text is a 510(k) Summary for the GE Medical Systems Information Technologies, Inc.'s CARESCAPE ONE device. It outlines the device's characteristics, intended use, and a comparison to a predicate device (K200494). However, it explicitly states that clinical studies were not required to establish substantial equivalence for this submission.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and the study that proves the device meets them, specifically in the context of human reader performance or ground truth established by experts beyond what is implied by general device performance testing. The focus of this 510(k) submission is on demonstrating substantial equivalence to a previously cleared device through non-clinical bench testing, not through a clinical study involving human readers and a robust ground truth determination process.

Here's what can be extracted from the document regarding "acceptance criteria" and "device performance" in a general sense, based on the non-clinical tests performed:

Summary of Non-Clinical Tests and Implied Acceptance Criteria:

The non-clinical tests performed demonstrate that the device meets its own specifications and relevant consensus standards. The "acceptance criteria" implicitly refer to compliance with these standards and the device's design specifications.

Implied Acceptance Criteria and Reported Device Performance (based on Non-Clinical Tests):

Here's why the other requested information cannot be provided from this document:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • This document focuses on non-clinical bench testing and compliance with standards. It does not mention clinical test sets, patient data, country of origin, or retrospective/prospective study design.

• 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)

  • No clinical user studies are mentioned that would require ground truth established by experts.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

  • Not applicable as there are no clinical test sets or expert reviews mentioned for adjudication.

• 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

  • The document explicitly states: "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." Therefore, no MRMC study or AI assistance effect size is discussed.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

  • While the device has algorithms (e.g., EK-Pro arrhythmia algorithm), the document focuses on the device's performance in meeting safety and compatibility standards, not on a standalone algorithm's performance where "human-in-the-loop" is a distinct variable to be tested. The algorithms themselves are "identical" to the predicate, implying their performance was previously accepted.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

  • Not relevant to the non-clinical bench testing described. Ground truth is not established in the context of clinical accuracy for this submission.

• 8. The sample size for the training set

  • The document does not describe the development or training of any AI/ML components or algorithms. It states that the measurement algorithms are "identical" to the predicate, suggesting they were already developed and validated.

• 9. How the ground truth for the training set was established

  • Not applicable as there is no mention of a training set or its associated ground truth.

In summary, this 510(k) submission for the CARESCAPE ONE device relies on demonstrating "substantial equivalence" to a previously cleared predicate device (K200494) through non-clinical bench testing and adherence to recognized standards, rather than new clinical studies involving human performance or ground truth established by experts.

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The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, 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 B105M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.

The monitor B105M, B155M, B105P and B125P are not intended for use during MRI.

The monitor B105M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.

The monitor B105M, B125M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric noninvasive blood pressure (systolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/ Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy and neuromuscular transmission (NMT).

The monitor B105M, B125M, B105P and B125P are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

The proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors that were developed based on predicate Monitor B125/B105(K201941) to provide additional monitored parameter: neuromuscular transmission (NMT), by supporting additional optional modules previously cleared by FDA: E-NMT module (K051635) with existing interface rack and/or second frame (B1X5-F2).

In addition to the added parameter, the proposed monitors B105M, B125M, B155M, B105P and B125P offer several software enhancements:

• Support 12-lead ECG measurement mode;
• Additional SPV (Systolic Pressure Variation) and PPV (Pulse Pressure Variation) values calculation;
• Enabled the Impedance Respiration measurement from lead RL-LL:
• Display Pulse Rate (PR) from NIBP when performing NIBP determination;
• Display real-time GE SpO2 Perfusion Index (PI) value; .
• Adoption of TruSignal V3 SpO2 algorithm;
• Additional optimizing IBP waveform scale function;
• Additional connectivity capabilities within GE CARESCAPE network (K032582) including Bed-to-Bed View and Automatic View on Alarm (AVOA);
• Additional remote service function:
• Additional cybersecurity enhancements.

The proposed monitors B105M, B125M, B155M, B105P and B125P include improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate Monitor B125/B105(K201941) while maintaining the same primary function and operation.

The five models (B105M, B125M, B155M, B105P and B125P) share the same hardware platform and software platform to support the data acquisition and algorithm modules. The differences between them are the LCD screen size and configuration options.

As with the predicate Monitor B125/B105 (K201941), the proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors, utilizing an LCD display and pre-configuration basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2, and optional parameters whic include CO2 and Gases parameters provided by the E-MiniC module (K052582), CARESCAPE Respiratory modules E-sCO and E-sCAiO (K171028), Airway Gas Option module N-CAiO (K151063), Entropy parameter provided by the E-Entropy module (K150298), Cardic Output parameter provided by the E-COP module (K052976), and thermal recorder B1X5-REC.

In addition, the predicate Monitor B125/B105 (K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P consists of the same interface to a variety of existing central station systems via a cabled or wireless network interface which implemented with identical integrated WIFI module. (WIFI feature is disabled in B125P/B105P)

Moreover, both the predicate Monitor B125/B105(K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided document is an FDA 510(k) Premarket Notification for a patient monitor. It does not describe a study involving an AI-driven device or an equivalent. Therefore, I cannot extract the information required to answer your prompt, as the prompt is geared towards AI/ML-based medical devices with specific performance metrics and validation studies.

The document focuses on demonstrating substantial equivalence of the new monitor models (B105M, B125M, B155M, B105P, B125P) to existing predicate devices (Monitor B125/B105, CARESCAPE B450, CARESCAPE VC150, CARESCAPE ONE). The changes primarily involve physical design, software enhancements (display modes, calculation additions, connectivity), and support for an additional, previously cleared, NMT measurement module. The document explicitly states:

"The subject of this premarket submission, the proposed monitors B105M, B125M, B155M, B105P and B125P did not require clinical studies to support substantial equivalence." (Page 16)

This indicates that the device's performance was evaluated through bench testing, cybersecurity assessments, and verification of software and hardware changes against established standards, rather than through comparative effectiveness studies with human readers or standalone algorithm performance studies typical for AI/ML devices. Therefore, a table of acceptance criteria and proven performance for an AI/ML component, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable or present in this document.

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