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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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