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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 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.

The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters.

The CARESCAPE ONE can be used as a standalone monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.

The CARESCAPE ONE can be connected as an accessory to a compatible CARESCAPE monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition. Visual and audible alarms, user controls, and user interface on the CARESCAPE ONE are not active in this mode.

The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE ONE is indicated 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, with CARESCAPE Software version 3 belongs to the CARESCAPE V3 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 we have ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, or CO2. 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, the CARESCAPE ONE screen and user interface is effectively disabled and it transmits data received from 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) Pre-Market Notification for the GE Healthcare CARESCAPE ONE device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (K190008, also CARESCAPE ONE).

However, the document does not describe a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML medical device (e.g., performance metrics like sensitivity, specificity, or AUC for an algorithm). Instead, this document focuses on demonstrating substantial equivalence to a previously cleared device. The "study" mentioned is primarily focused on compliance with updated medical standards and the ability of the device to function as an acquisition module when connected to a host monitor, rather than a clinical performance study of a novel algorithm against pre-defined acceptance criteria.

Specifically, the document states:

• "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." (Page 14)
• The only "clinical study" mentioned ("U-TruSignal SpO2, Testing in Neonates") is related to a component (GE TruSignal sensors) and is described as an update to older data to ensure compliance with a specific FDA guidance for pulse oximeters, not a general performance study of the CARESCAPE ONE itself or its new features. It explicitly states there is "no change to the GE TruSignal Parameter active cable module in hardware, software or pulse oximetry algorithm, or in the sensors used compared to the predicate CARESCAPE ONE (K190008)."

Therefore, based on the provided text, I cannot extract information regarding a study that proves the device meets acceptance criteria in terms of algorithmic performance against a defined ground truth using a test set, expert consensus, etc. The submission's focus is on demonstrating safety and effectiveness through substantial equivalence and compliance with relevant standards.

Therefore, many parts of your request cannot be answered directly from the provided text.

Here's what can be extracted and inferred, with limitations noted:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for algorithmic performance, nor does it present "reported device performance" in terms of specific diagnostic or predictive metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this submission are focused on demonstrating substantial equivalence to a predicate device and compliance with updated industry standards.

The table on pages 8-9 compares the new CARESCAPE ONE to the predicate CARESCAPE ONE (K190008) across various specifications. The "Discussion of Differences" column implicitly reflects the "performance" relative to the predicate, often stating "Identical" or "Equivalent". For example, for "Medical Standards," the acceptance criterion would be compliance with the listed standards, and the reported performance is that it complies with newer editions. For "Monitored Parameters" and "EK-Pro arrhythmia detection algorithm," the performance is that they are "Identical" to the predicate.

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

• Test Set Sample Size: Not applicable in the context of an algorithmic performance test. The clinical study mentioned "U-TruSignal SpO2, Testing in Neonates" used "convenience samples collected in neonatal patients." The exact sample size is not stated in this document.
• Data Provenance: Not specified for the "U-TruSignal SpO2, Testing in Neonates" study. It's noted as a clinical study, implying prospective data collection, but no further details are given.

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)

Not applicable. The document does not describe a study involving expert readers or establishing ground truth for an AI algorithm. The mentioned "clinical study" pertains to pulse oximetry sensor performance, which typically relies on arterial blood gas measurements for ground truth, not expert adjudication in the traditional sense of image interpretation.

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

Not applicable. No expert adjudication method is described.

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

No. The document explicitly states: "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." This type of MRMC study is not mentioned or implied.

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

Not applicable in the context of a new AI algorithm. The device incorporates existing algorithms (like EK-Pro arrhythmia detection V14) which were part of the predicate device and are stated to be "identical." The type of "performance" testing done was bench testing and verification of compliance with updated standards.

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

For the "U-TruSignal SpO2, Testing in Neonates" study, the ground truth for pulse oximetry studies typically involves direct arterial blood gas measurements (SaO2), considered the "gold standard" for oxygen saturation. The document mentions compliance with "Pulse Oximeters - Premarket Notification Submissions [510(k)s], Guidance," which outlines the ground truth methodology for such devices.

8. The sample size for the training set

Not applicable. This submission is not about a new AI/ML algorithm that requires a training set. The device utilizes existing algorithms.

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

Not applicable. As above, this document does not describe a new AI/ML algorithm requiring a training set with established ground truth.

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The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters.

The CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.

The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated 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 is a new patient monitor device based on GE Healthcare predicate devices, the Patient Data Module (K071073) and the CARESCAPE B450 (K132533).

CARESCAPE ONE, with CARESCAPE Software version 3 belongs to the CARESCAPE V3 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 parameter, including ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, or CO2. 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. The ACM's are CARESCAPE TEMP, CARESCAPE PRES, CARESCAPE ECG, CARESCAPE SpO2 (TruSignal), CARESCAPE SpO2 -Nellcor, CARESCAPE SpO2 - Masimo and CARESCAPE CO2 - LoFlo. CARESCAPE SpO2 - Nellcor, CARESCAPE SpO2 -Masimo, and CARESCAPE CO2 - LoFlo have been developed by their respective companies/manufacturers (OEM) for use with the CARESCAPE ONE. The technology from each OEM has received 510(k) clearance and is adapted to function with the CARESCAPE ONE. The OEM technologies are not new and are not a part of this submission, only their integration into the Parameters/Active Cable Modules for use with the CARESCAPE ONE is covered in this 510(k).

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.

Here's an analysis of the acceptance criteria and supporting studies for the CARESCAPE ONE device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a direct table of specific acceptance criteria with corresponding performance values for all features. However, it does highlight performance claims and comparisons for key components, specifically arrhythmia detection and SpO2.

2. Sample Size Used for the Test Set and Data Provenance

• Arrhythmia (EK-Pro V14): The document references ANSI/AAMI EC57:1998 (R)2012. This standard specifies databases (e.g., AHA, MIT-BIH) that are used for testing arrhythmia algorithms. The specific sample size from these databases used for EK-Pro V14 testing is not explicitly stated in this 510(k) summary, but it would be derived from the standard's requirements.
  • Data Provenance: The databases mentioned in EC57 are typically retrospective, internationally recognized ECG databases. The exact country of origin for the data used for this specific EK-Pro V14 validation is not specified, but the standard's databases often compile data from various global sources.
• SpO2 (TruSignal V3): The document states a "controlled desaturation study." The sample size is not explicitly stated in this summary.
  • Data Provenance: A controlled desaturation study is a prospective clinical study designed to test pulse oximeter accuracy. The country of origin for this study is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Arrhythmia (EK-Pro V14): When using standard databases like those referenced by ANSI/AAMI EC57, the ground truth (arrhythmia annotations) is typically established by multiple, highly experienced cardiologists or cardiac electrophysiologists. The exact number and qualifications for the original annotation of the standard databases are not specified in this document, as the standard itself defines these.
• SpO2 (TruSignal V3): For controlled desaturation studies, the "ground truth" for SpO2 is provided by a CO-oximeter measurement, which itself is a highly accurate laboratory method for oxygen saturation. This is an objective measurement rather than expert consensus. Therefore, "experts" in the traditional sense for establishing ground truth are not directly applicable here.

4. Adjudication Method for the Test Set

• Arrhythmia (EK-Pro V14): For standard databases, ground truth annotation often involves multiple experts reviewing and adjudicating discrepancies, sometimes with a "majority rules" or senior expert decision process. The specific adjudication method for the creation of the databases referenced by EC57 is not detailed in this summary, but would adhere to the methodologies defined by the creators of those databases.
• SpO2 (TruSignal V3): As the ground truth comes from CO-oximetry, an objective measurement, adjudication by experts is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." This indicates that human-in-the-loop performance with or without AI assistance was not assessed in this submission for primary equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Yes, standalone performance was assessed for key algorithms:
  • EK-Pro V14 Arrhythmia Detection algorithm: Its performance was evaluated against the ANSI/AAMI EC57 standard, comparing it to the predicate's EK-Pro V13 algorithm. This is a standalone algorithm performance evaluation.
  • TruSignal V3 SpO2 algorithm: Its accuracy was validated in a controlled desaturation study against CO-oximetry. This is also a standalone algorithm performance evaluation.

7. The Type of Ground Truth Used

• Arrhythmia (EK-Pro V14): The ground truth would be expert consensus annotations of ECG waveforms from standard arrhythmia databases (e.g., those specified in ANSI/AAMI EC57).
• SpO2 (TruSignal V3): The ground truth was objective laboratory measurement using CO-oximetry in a controlled study. This is considered a gold standard for blood oxygen saturation.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size used for training the EK-Pro V14 arrhythmia detection algorithm or the TruSignal V3 SpO2 algorithm. In 510(k) submissions, training set details (especially for existing, updated algorithms) are often not required to be as extensively disclosed as test set performance, particularly when demonstrating equivalence to a predicate.

9. How the Ground Truth for the Training Set was Established

• The document does not explicitly state how the ground truth for the training sets of the EK-Pro V14 or TruSignal V3 SpO2 algorithms was established. For complex algorithms like these, training data is typically meticulously annotated by a combination of clinical experts (for arrhythmia) or using highly accurate reference methods (for SpO2) and then verified. Again, in a 510(k) for an updated algorithm or component, the full developmental history and training data specifics may not be detailed if the focus is on demonstrating equivalent performance post-modifications.

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