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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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