Search Results

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.

Ask a specific question about this device

The Solar 8000M System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in the use of the equipment. The Solar 8000M is a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment. The Solar 8000M System is capable of monitoring electrocardiogram, non-invasive pressure, pulse, invasive blood pressure, blood temperature, cardiac output, respiration, pulse oximetry, venous O2 saturation, Transcutaneous O2 and CO2 respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations, impedance cardiography, electroencephalography and bispectral index. O2 and CO2 concentrations are available for neonates not under anesthesia. Information can be displayed, trended and stored in the monitor from a variety of peripheral devices. The Solar 8000M System is also intended to provide physiologic data over the UNITY Tu network. The Solar 8000M System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

The Solar 8000M System includes the following basic components: Solar 8000M processing unit a display TRAM-rac housing acquisition module(s) keypad and/or remote control Additional, optional components include: Clinical Information Center (central station) Remote display digital writer or printer TRAM-Net interface adapter(s) Octanet connectivity device Remote Alarm Box

This submission describes a patient monitoring system and does not contain detailed performance metrics or specific acceptance criteria in the format typically seen for algorithm-based devices. Therefore, I cannot extract all the requested information for acceptance criteria and a study that proves the device meets them.

However, I can provide information based on the available text:

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported device performance values. The "Test Summary" only lists the types of tests performed.

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

The document does not specify a sample size for any "test set" in the context of an algorithm's performance. It mentions "Clinical use validation" but provides no details on the number of patients, data origin, or whether it was retrospective or prospective.

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

This information is not provided. The submission focuses on hardware and system functionality, not algorithmic interpretation requiring expert ground truth.

4. Adjudication Method:

This information is not provided.

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

No MRMC study is mentioned. This submission is about a patient monitoring system, not an AI-assisted diagnostic tool.

6. Standalone Performance:

The document does not describe standalone (algorithm-only) performance in the sense of a diagnostic algorithm without human intervention. The device's function is to display and store physiological data for healthcare practitioners.

7. Type of Ground Truth Used:

The concept of "ground truth" as it applies to diagnostic algorithms (e.g., pathology, expert consensus) is not relevant to this submission. The "ground truth" for a patient monitor would be the actual physiological readings, which are measured directly by the device's sensors. The document states "performance testing" was done, implying comparison against expected physiological values or established calibration standards for each parameter monitored.

8. Sample Size for the Training Set:

This information is not applicable. The device described is a physiological patient monitor, not an AI/ML algorithm that undergoes a "training set."

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

This information is not applicable, as there is no training set for an AI/ML algorithm.

Summary of available information related to performance and testing:

Acceptance Criteria (Implicit and general, not specific metrics):

• Safety: The device is as safe as the predicate device.
• Effectiveness: The device is as effective as the predicate device.
• Performance: The device performs as well as the predicate device.
• Compliance: The device complies with voluntary standards.
• Functionality: Adherence to requirements (via requirements reviews, design reviews, unit, integration, and final acceptance testing).
• Environmental Robustness: Successful environmental testing.

Study/Testing Information:

The document mentions a "Test Summary" with the following quality assurance measures and testing:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Final acceptance testing (Validation)
• Performance testing
• Safety testing
• Environmental testing
• Clinical use validation

Conclusion from the Submission:

"The results of these measurements demonstrated that the Solar 8000M System are as safe, as effective, and perform as well as the predicate device."

Predicate Device: K993757 Solar 7/8000 System

In essence, this 510(k) submission establishes substantial equivalence to a predicate device based on similar technology and comprehensive quality assurance testing, rather than an AI-specific performance study with detailed acceptance criteria and ground truth analysis.

Ask a specific question about this device