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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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The Mac-Lab System is intended for use in a catheterization and related cardiovascular specialty laboratories under the direct supervision of a licensed healthcare practitioner. It is intended to monitor, calculate and/or record cardiovascular data from adult and pediatric patients undergoing cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG, heart rate, pulse oximetry (SpO2), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure and procedural information and optional intracardiac electrocardiogram (IECG). Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices. The Mac-Lab System does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during procedure. The Mac-Lab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

The CardioLab EP System is intended for use in an electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. It is intended to monitor, calculate and/or record electrophysiological data from adult and pediatric patients under going electrophysiological studies. Data includes: ECG, pressure, and intracardiac electrocardiogram (IECG) waveforms, heart rate, pulse oximetry (SpO2), respiration rate, EtCO2, temperature, invasive and noninvasive blood pressure, and procedural information. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and RF generators. The CardioLab EP System does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during the procedure. The CardioLab EP System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

The ComboLab System is the combination of the both the Mac-Lab and CardioLab EP systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related speciality laboratories under the direct supervision of a licensed healthcare practitioner. The ComboLab System allows the user to run either the Mac-Lab System or the CardioLab EP System, although only one may be used at a time.

The Mac-Lab System is a microprocessor based data acquisition system used during cath procedures to monitor, calculate and record physiological data from pediatric or adult patients. Data may be entered manually or acquired via an interfaced GE Medical Systems Information Technologies acquisition device, such as: TRAM module (K011000), EtCO2 module (K904789), CardioLab Amplifier Module (K910307), DASH 3000/4000 Monitor (K001359), Solar 8000M Monitor (K993757), MUSE cardiovascular system (K992637) or other peripheral interface. Data includes: ECG, pressure, respiration intracardiac electrocardiograms (IECG), and SpO2 waveforms, heart rate, pulse oximetry (SpO2), respiration rate, valve gradients and areas, cardiac output, EtCO2, hemodynamic measurements, invasive and noninvasive blood pressure, temperature, and procedural information. The Mac-Lab joins together the acquisition devices with computer processors, software, highresolution display monitors, power supply, printers, keyboard and mouse. Digital data is transmitted, via cable, from the acquisition devices to the computer for processing. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to the CardioLink INW server and other networked hospital information systems.

The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiology procedures to monitor, calculate and record physiological data from pediatric or adult patients. Data may be entered manually or acquired via an interfaced GE Medical Systems Information Technologies acquisition device, such as: CardioLab Amplifier Module (K910307), TRAM module (K011000), EtCO2 module (K904789), DASH 3000/4000 Monitor (K001359), Solar 8000M Monitor (K993757), MUSE cardiovascular system (K992637) or other peripheral interface, such as RF generators and fluoro video Data includes: ECG. intracardiac pressure waveforms, heart rate, pulse electrocardiograms (IECG), and oximetry (SpO2), respiration rate, EtCO2, invasive and noninvasive blood pressure, temperature, and procedural information. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient by third-party devices such as ECG leadwires and catheters. The amplifier filters, amplifies, digitizes and transmits the data to the computer via fiber optic cable. The CardioLab joins together the acquisition devices with computer processors, software, high-resolution display monitors, power supply, printers, Digital data is transmitted, via cable, from the keyboard and mouse. acquisition devices to the computer for processing. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to the CardioLink INW server and other networked hospital information systems.

The product will be available in three configurations: CardioLab EP application only, Mac-Lab application only, or a combination of both CardioLab EP and Mac-Lab applications. The 'CardioLab EP only's configuration only allows the user to run the CardioLab EP mode. The 'Mac-Lab only' configuration only allows the user to run the Mac-Lab mode. The ComboLab configuration is the combination of both CardioLab EP and Mac-Lab modes, though only one mode may be used at a time (CardioLab EP for electrophysiological lab cases and Mac-Lab for catheterization lab cases).

Here's a breakdown of the acceptance criteria and study information for the Mac-Lab/CardioLab EP/ComboLab System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state a specific sample size for a test set in the context of validating algorithm performance or diagnostic accuracy. The testing mentioned (Unit-level, Integration, Final Acceptance, Performance, Safety, Environmental) seems to focus on the system's functional and safety aspects, rather than a clinical accuracy study with a defined test set.

• Sample Size: Not specified for performance validation of algorithms or diagnostic accuracy.
• Data Provenance: Not specified. The mention of "Clinical Use Validation" suggests some form of clinical data was involved, but details like country of origin or retrospective/prospective nature are absent.

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

This information is not provided in the given text. The submission references "Clinical Use Validation" but does not detail how ground truth was established or if experts were involved in a diagnostic accuracy assessment for a test set.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done? No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission focuses on demonstrating equivalence to a predicate device via functional and safety testing.
• Effect Size: Not applicable, as no MRMC study was reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device described is a data acquisition and display system for physiological data, not an AI or algorithm-driven diagnostic tool that would typically have a "standalone" performance assessment in the absence of a human. Its function is to "monitor, calculate and/or record" data. Therefore, a standalone algorithm performance study, as typically understood for AI devices, was not conducted or reported. The validation focused on the system's ability to accurately acquire, process, and display physiological data, which inherently involves human interpretation.

7. Type of Ground Truth Used

The text does not specify a "ground truth" in the context of diagnostic accuracy. Given the nature of the device (data acquisition, monitoring, calculation, and recording of physiological parameters), the "ground truth" would likely be the accurate and verifiable physiological signals and measurements themselves, rather than a diagnostic outcome (like pathology or a physician's final diagnosis). The system derives physiological parameters (diastolic/systolic BP, heart rate, cycle length) from signal data but doesn't perform diagnostic analysis or have arrhythmia detection capabilities.

8. Sample Size for the Training Set

The text does not mention a training set size. This type of device, which is primarily a data acquisition and display system based on well-established physiological monitoring principles, would not typically involve "training" in the machine learning sense. Its functionality is based on predefined algorithms for processing signals, not learning from a dataset.

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

Not applicable, as no training set is mentioned or implied for this type of device.

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The Aware™ Transport Monitor System (includes Aware POD and Aware Transport Monitor) 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 medical facility, such as a hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care.

The Aware POD is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the Aware POD includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.

The Aware Transport Monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Aware POD or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. Both the Aware POD and TRAM acquisition module acquire, process and store information for all aforementioned parameters.

The Aware™ Transport Monitor System is a complete, high-acuity patient monitoring system composed of two main parts: the Aware POD and Aware Transport Monitor.

The Aware™ Patient Observation Device (POD) is an acquisition module that measures and processes a patient's physiological parameters. Physiological parameter data acquired by the Aware POD includes 12 Lead ECG, respiration, up to four invasive blood pressure channels (as options), non-invasive blood pressure, Masimo SpO2, dual temperature and cardiac output (optional).

The Aware™ Transport Monitor is designed to be lightweight, rugged, and provide continuous monitoring capability when coupled with a compatible acquisition module. The Aware Transport Monitor is designed to facilitate quick, simple connection of either the Aware POD or TRAM 2001 module (K011000). The Aware Transport Monitor provides a means to alert the clinician of limit violations via audible and visual alarms.

Acceptance Criteria and Device Performance Study for Aware™ Transport Monitor System

This document outlines the acceptance criteria and a summary of the study used to demonstrate that the Aware™ Transport Monitor System meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of specific numerical acceptance criteria. Instead, it broadly states that the device "complies with the voluntary standards as detailed in Section 9 of this submission" and that "The results of these measurements demonstrated that the Aware Transport Monitor System is as safe, as effective, and performs as well as the predicate devices."

Based on the information available, the acceptance criteria are implicitly tied to a combination of:

• Compliance with Voluntary Standards: Adherence to established industry and regulatory standards relevant to physiological patient monitors. (Specific standards are not detailed in the provided text.)
• Equivalency to Predicate Devices: Performance characteristics (safety and effectiveness) should be comparable to the legally marketed predicate devices (K011000 TRAM 2001 Module).

Implicit Acceptance Criteria & Reported Performance:

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

The document indicates "Clinical Use Validation" and various levels of testing (unit, integration, final acceptance, performance, safety, environmental). However, it does not specify a distinct "test set" and a corresponding sample size for clinical validation nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of clinical data). The testing described seems to be more focused on engineering verification and validation rather than a separate clinical performance study with a defined patient cohort.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not mention the use of experts to establish ground truth for a test set, nor does it specify their number or qualifications. The clinical validation is mentioned, but the methodology for assessing clinical outcomes or establishing "truth" for the device's physiological parameter measurements is not detailed beyond general testing.

4. Adjudication Method

The document does not describe any adjudication method used for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The device is a physiological monitor, not an imaging or diagnostic AI-assisted device where such studies are typically performed to assess human reader improvement. There is no information about AI assistance or human-in-the-loop performance improvement.

6. Standalone (Algorithm Only) Performance Study

Given that the device is a physiological patient monitor, its primary function is data acquisition and display. The concept of "standalone (algorithm only)" performance without a human in the loop is not directly applicable in the same way it would be for an AI diagnostic algorithm. The device's performance is inherently tied to its ability to accurately measure and process physiological parameters, which is implicitly evaluated through the "performance testing" and "clinical use validation." However, a specific standalone performance study report with metrics akin to AI algorithms is not provided.

7. Type of Ground Truth Used

The type of "ground truth" used for validating the accuracy of physiological parameter measurements is not explicitly stated. For physiological monitors, ground truth typically involves comparison against established reference devices or invasive measurements (e.g., arterial line for blood pressure, direct temperature probes, or gold-standard ECG recording systems). The document generally refers to "measurements" and "clinical use validation" without specifying the reference methods.

8. Sample Size for the Training Set

The document does not refer to a "training set" as the device is not described as utilizing machine learning or AI that would require a distinct training phase with a dataset. The development process mentions "Requirements Reviews," "Design Reviews," and various levels of testing, which are standard for medical device engineering but do not imply an AI model training paradigm.

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

As there is no mention of a training set for an AI or machine learning model, the method for establishing ground truth for such a set is not applicable and hence not provided.

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MAC-LAB System: The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare to monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via an interfaced GE Medical Systems Information Technologies TRAM modules (K01 1000), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). This information can be displayed, trended, stored, printed and/or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

CardioLab EP System: The CardioLab EP System is intended for use under the direct supervision of a licensed healthcare practitioner to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. The system does not transmit alarms or arrhythmias, and does not have archythmia detection capabilities.

The ComboLab System: The ComboLab is the combination of both CardioLab EP and MAC-LAB allowing the user to run the CardioLabEP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases). The system does not transmit alarms or anthythmias, and does not have arrhythmia detection capabilities.

The MAC-LAB/CardioLab EP/ComboLab Systems do not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during procedure.

Applicable to pediatric/adult patients requiring cardiac/circulatory system catheterization. Intended for use in catheterization and related cardiovascular specialty labs.

The MAC-LAB System is a microprocessor based data acquisition system used during cardiac catheterization procedures. The MAC-LAB system, via various models of the GE Medical Systems Information Technologies TRAM module (K011000) and amplifier module, acquires patient data which may include surface ECG, invasive and non-invasive blood pressure, blood oxygen saturation via pulse oximetry, respiration, and temperature, The TRAM module is housed in a dedicated front end chassis called the remote acquisition case (RAC). The MAC-LAB System joins together the TRAM module and amplifier module with computer processors, software, high resolution display monitors, power supply, laser printer, keyboard and mouse. Digital data is transmitted, via cable, from the TRAM module and/or amplifier module to the computer for processing. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to other information systems via L.A.N.

The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiology procedures to acquire ECG, intracardiac signals, and pressure signals via amplifier module. Digital data is also acquired from other devices such as RF generators, fluoro video systems and the GE Medical Systems Information Technologies TRAM module. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient by third-party devices such as ECG leadwires and catheters. The amplifier filters, amplifies, digitizes and transmits the data to the computer via fiber optic cable. The computer stores the data on optical disks, displays the data on the video monitors, allows the user to perform basic signal measurements, and prints out waveforms on a laser printer or continuous paper recorder. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to other information systems via LAN.

The product will be available in three configurations: CardioLab EP application only, MAC-LAB application only, or a combination of both CardioLab EP and MAC-LAB applications. The 'CardioLab EP only' configuration only allows the user to run the CardioLab EP modes. The 'MAC-LAB only' configuration only allows the user to run the MAC-LAB mode. The combination of both CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiological lab cases and MAC-LAB for catheterization lab cases).

This document is a 510(k) summary for the MAC-LAB/CardioLab EP/ComboLab System Version 6.0. It describes the device's intended use and states that it employs the same functional technology as a predicate device (K021366). However, the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, most of the requested information cannot be extracted from the given input.

Here's a breakdown of what can be stated based on the provided text, and what cannot:

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

• Cannot be provided. The document does not define specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity values) for any aspect of the device's performance. It also does not report performance metrics against such criteria.

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

• Cannot be provided. The document states that the new device employs the "same functional technology as the predicate device" but does not describe any specific testing or clinical study for this 510(k) submission that would involve a test set, sample size, or data provenance. 510(k) submissions often rely on substantial equivalence to a predicate device rather than new clinical trials, especially for Class II devices like this.

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)

• Cannot be provided. No test set or ground truth establishment is described.

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

• Cannot be provided. No test set or 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

• Cannot be provided. This document describes a cardiac catheterization and electrophysiology system for data acquisition and display, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or AI assistance effect size is not applicable to the device as described.

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

• Cannot be provided. The device is a data acquisition system for use "under the direct supervision of a licensed healthcare practitioner." It explicitly states it "does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during procedure." This strongly indicates it's not a standalone diagnostic algorithm but rather a tool for practitioners.

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

• Cannot be provided. No ground truth is described.

8. The sample size for the training set

• Cannot be provided. The document describes a medical device system, not an AI or machine learning algorithm that would typically involve a training set.

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

• Cannot be provided. No training set or ground truth establishment is described.

Summary based on the document:

The 510(k) submission for the MAC-LAB/CardioLab EP/ComboLab System Version 6.0 relies on demonstrating substantial equivalence to a predicate device (K021366), rather than presenting new performance data against specific acceptance criteria. The document states:

• Technology: "The proposed MAC-LAB/CardioLab EP/ComboLab System Version 6.0 employs the same functional technology as the predicate device."

This implies that the device is considered to meet implicitly acceptable performance levels because its technology and intended use are the same as a device already cleared by the FDA. Such submissions typically do not include detailed performance studies with acceptance criteria, ground truth, or sample sizes unless there are significant technological differences or new intended uses that raise new questions of safety or effectiveness.

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