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Mac-Lab: The Mac-Lab System is intended for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. The Mac-Lab System is configurable. Clinical data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, CO2 (EtCO2), temperature, hemodynamic measures [e.g. valve gradients and areas, cardiac output, shunts, Fractional Flow Reserve (FFR), invasive and noninvasive blood pressure] Physiological parameters such as diastolic. systolic, mean pressures, and heart rate are derived from the signal data, displayed and recorded. The data is entered manually or acquired via interfaced devices and/or information systems and may be used for report generation. Procedural information and optional anatomical and physiological imaging and data devices may be interfaced (e.g. X-ray, ultrasound, patient monitors and information systems). The Mac-Lab System can display, store and annotate images previously acquired and stored by other systems. Data may be provided to other systems via multiple formats (e.g. HL7, DICOM. Analog outputs). Data may be received from other devices via multiple formats (e.g. DICOM, Analog inputs). Optional accessories for hardware and software include research tools to be used exclusively outside active patient care settings. The purpose of the research tools is to assist researchers or clinicians in developing algorithms. The Mac-Lab System does not have alarms, does not generate energy delivered to the patient, does not administer drugs and does not perform any life-supporting or life-sustaining functions. The Mac-Lab System is not intended for use on unattended patients, or in situations where diagnostic arrhythmia detection is required. The Mac-Lab System provides the ability to transmit patient data for storage, analysis and viewing at distributed locations within a clinical facility via network connectivity. The Mac-Lab System also functions as a stand-alone device. The Mac-Lab System is used in a variety of hospital and clinical settings interventional laboratories (e.g. cardiac catheterization and radiology), operating room environments, and post areas all under the direct supervision of licensed healthcare practitioners who are responsible for interpreting the data.

CardioLab: The CardioLab System is intended for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. The CardioLab System is configurable. Clinical data includes: ECG waveforms, intracardiac signals, stimulus data, ablation data, pulse oximetry (SpO2), respiration rate, CO2 (EtCO2), temperature, and invasive and noninvasive blood pressure. Physiological parameters such as diastolic, systolic, mean pressures, heart rate, and cycle length are derived from the signal data, displayed and recorded. The data is entered manually or acquired via interfaced devices and/or information systems and may be used for report generation. Procedural information and optional and physiological imaging and data devices may be interfaced [e.g. X-ray, ultrasound, mapping systems, ablation generators (e.g. RF and cryogenic)], stimulators, patient monitors and information systems. The CardioLab System can display, store and annotate images previously acquired and stored by other systems. Data may be provided to other systems via multiple formats (e.g. HL7, DICOM, Analog outputs). Data may be received from other devices via multiple formats (e.g. DICOM, Analog inputs). Optional accessories for hardware and software include research tools to be used exclusively outside active patient care settings. The purpose of the research tools is to assist researchers or clinicians in developing algorithms. Optional accessories for hardware and software include a waveform simulator to be used exclusively outside active patient care settings. The waveform simulator may be used for training, demonstration without a patient attached, and as a troubleshooting tool on the CardioLab System. The CardioLab System does not have alarms, does not generate energy delivered to the patient, does not administer drugs and does not perform any life-sustaining functions. The CardioLab System is not intended for use on unattended patients, or in situations where diagnostic arrhythmia detection is required. The CardioLab System provides the ability to transmit patient data for storage, analysis and viewing at distributed locations within a clinical facility via network connectivity. The CardioLab System also functions as a stand-alone device. The CardioLab System is used in a variety of hospital and clinical settings including interventional laboratories (e.g. electrophysiology and cardiac catheterization), operating room environments, and pre and post areas all under the direct supervision of licensed healthcare practitioners who are responsible for interpreting the data.

SpecialsLab: The SpecialsLab System executes the same software and runs on the same hardware in the same environments as the Mac-Lab System. Products designated as a SpecialsLab System support fewer options than the Mac-Lab system.

ComboLab: The ComboLab System is the combination of both the Mac-Lab and CardioLab Systems. The ComboLab System allows the user to run either the Mac-Lab System or the CardioLab System, although only one system may be used at a time. The ComboLab System executes the same software and runs on the same hardware in the same environments as the Mac-Lab and CardioLab Systems.

Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems are hemodynamic and electrophysiology (EP) recording systems. The product will be available in the following configurations: Mac-Lab System, CardioLab System, SpecialsLab System, or a combination of both Mac-Lab and CardioLab marketed as the ComboLab System. The product designated as SpecialsLab is the same as the Mac-Lab System with the exception that it will support fewer options. The SpecialsLab System performs the same intended use as the Mac-Lab, executes the same software, and runs on the same hardware. The Mac-Lab, CardioLab, and ComboLab Recording Systems are each available in several configurations ranging from basic to advanced functionality.

The document provided is a 510(k) summary for GE Healthcare's Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems v6.9.5. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study.

Here's an analysis based on your requested information:

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

This information is not provided in the document. The 510(k) summary for this type of device (a hemodynamic and electrophysiology recording system update) typically focuses on demonstrating that the new version is as safe and effective as the predicate device. It highlights new features or changes and asserts that these changes do not raise new questions of safety or effectiveness. Specific performance acceptance criteria and reported numerical performance values against those criteria are generally not part of a 510(k) summary for software updates in this context, especially when no clinical studies were deemed necessary.

The document states: "The Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems and their applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission." However, the specific acceptance criteria from these voluntary standards and the device's measured performance against them are not included in this summary.

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

This information is not applicable as the document explicitly states: "The subject of this premarket submission, Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems and their applications did not require clinical studies to support substantial equivalence." Therefore, there was no "test set" of patient data in the context of a clinical performance study. The testing mentioned (unit, integration, performance, safety, simulated use) would have been internal engineering and validation testing, not a clinical trial with a patient data test set.

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)

This information is not applicable as no clinical studies were performed, and thus no ground truth was established by human experts for a clinical test set.

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

This information is not applicable as no clinical studies requiring adjudication of a test set were conducted.

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

An MRMC study was not performed, nor is it applicable. This device is a recording system, not an AI-assisted diagnostic tool for interpretation by human readers. It collects and displays physiological data. The update involves "an additional data acquisition alternative" (PDM support) and "software application enhancements to existing features and functions." These changes do not relate to AI assistance for human interpretation.

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

A standalone performance study of an algorithm is not applicable to this device. This is a system for acquiring, displaying, and recording physiological data, not an algorithm providing a diagnostic output that would typically undergo standalone evaluation.

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

This information is not applicable as no clinical studies requiring a ground truth were performed.

8. The sample size for the training set

This information is not applicable. The device described is a hemodynamic and electrophysiology recording system, updated with new data acquisition and software enhancements. It does not appear to utilize machine learning or AI that would require a "training set" in the conventional sense for algorithm development. The "research tools" mentioned are for clinicians to develop algorithms, implying the device itself is not an algorithm-driven diagnostic tool relying on a training set.

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

This information is not applicable as there is no indication of a training set or ground truth in the context of machine learning.

Summary of the Study:

The "study" presented here is a non-clinical assessment for substantial equivalence. The document confirms that "The subject of this premarket submission... did not require clinical studies to support substantial equivalence."

Instead, substantial equivalence was demonstrated through:

• Comparison to a predicate device: K111200 Mac-Lab, CardioLab, ComboLab, and SpecialsLab System.
• Assessment of technological characteristics: The proposed systems "employ the same fundamental scientific technology as the predicate devices." The update includes additional data acquisition alternatives (PDM support) and software application enhancements to existing features.
• Compliance with voluntary standards: Stated without providing details in this summary.
• Quality assurance measures applied to development: Including Risk Analysis, Requirements Reviews, Design Reviews, Unit Testing, Integration Testing, Performance Testing, Safety Testing, and Simulated Use Testing. These are internal validation activities, not clinical trials.

In essence, this 510(k) summary asserts that the changes in v6.9.5 are minor and do not alter the safety or effectiveness of the device compared to the previously cleared predicate, thus no new clinical data or performance acceptance criteria against patient data sets were required by the FDA for this particular submission.

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