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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, and 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 including interventional laboratories (e.g. cardiac catheterization and radiology), operating room environments, and pre 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 anatomical 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 includes 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-supporting or 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 application, CardioLab application, SpecialsLab application, or a combination of both CardioLab and Mac-Lab applications marketed as ComboLab. 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 full advanced functionality.

The provided document is a 510(k) Premarket Notification Submission for GE Healthcare's Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems. This type of submission is for medical devices that are substantially equivalent to legally marketed predicate devices.

Medical device submissions for substantial equivalence do not typically include acceptance criteria, performance tables, or clinical studies of the type described in the prompt (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance). Instead, the focus is on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness.

Here's a breakdown based on the provided text, addressing the prompt's points where applicable, and explaining why other points cannot be addressed:

Response to Prompt:

Based on the provided 510(k) Summary, the device did not require a clinical study to demonstrate that it meets acceptance criteria because it is being submitted for substantial equivalence to a predicate device. The document explicitly states:

"The subject of this premarket submission, Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems, did not require clinical studies to support substantial equivalence." (Page 4, "Summary of Clinical Tests")

Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not available or applicable in this submission. The submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of fundamental scientific technology.

However, I can provide information based on the "Summary of Non-Clinical Tests" mentioned:

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

• Not applicable / Not provided. The submission focuses on substantial equivalence to a predicate device, not on meeting specific, de novo acceptance criteria with reported performance values from a clinical study. The non-clinical tests mentioned are quality assurance measures, not performance metrics against specific acceptance thresholds.

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

• Not applicable / Not provided. No clinical test set or data provenance is detailed, as clinical studies were not required. The non-clinical tests (e.g., unit testing, integration testing) would not typically involve patient data or sample sizes in the context of clinical performance evaluation.

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 / Not provided. No clinical ground truth establishment is described, as clinical studies were not required.

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

• Not applicable / Not provided. No clinical 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

• Not applicable / Not provided. No MRMC study was conducted or is documented, nor is there any mention of AI assistance in the context of human reader performance. This device is an EP/hemodynamic recording system, not an AI diagnostic tool.

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

• Not applicable / Not provided. The device is a recording system, not an algorithm performing a diagnostic task independently. Its function is to acquire, process, display, and record physiological data for interpretation by licensed healthcare practitioners.

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

• Not applicable / Not provided. No clinical ground truth is detailed, as clinical studies were not required. The non-clinical tests likely used engineering specifications and reference standards as a "ground truth" for verification.

8. The sample size for the training set

• Not applicable / Not provided. This device is not described as utilizing a machine learning algorithm that would require a "training set" in the conventional sense for AI/ML performance evaluation. Its software development followed traditional quality assurance measures.

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

• Not applicable / Not provided. (See point 8).

Information from the Document Regarding Device Performance and Verification:

While specific acceptance criteria and clinical performance data are not provided, the document does list the quality assurance measures applied during the development of the system to ensure its functionality and safety, implying these serve as the verification methods against internal requirements:

Summary of Non-Clinical Tests (Page 4):
The Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems and their applications comply with voluntary standards (as detailed in Sections 9, 11, and 17 of the submission, which are not provided here). The following quality assurance measures were applied:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use and Usability testing (Validation)

These measures confirm that the device was developed following a robust quality system and that its functions were verified and validated against design requirements and intended use within a non-clinical context. The basis for its market clearance is "substantial equivalence" to existing predicate devices (K061741 Mac-Lab, CardioLab, ComboLab, and SpecialsLab System), rather than de novo clinical proof of specific performance metrics against pre-defined acceptance criteria.

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The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare practitioner 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 Marquette TRAM modules (K921669), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO-), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG).

Applicable to pediatric/adult patients requiring cardiac/circulatory system catheterization

Intended for use in catheterization and related cardiovascular specialty labs

The MAC-LAB Systems ioin together the TRAM module which is housed in a Remote Acquisition Unit (RAU) with computer processors, software, high resolution display monitors, power supply, thermal printer and a keyboard. Data acquisition modules, depending upon application, are inserted into the RAU and then digital data is transmitted, via cable, to the computers for An optional IECG module (K935394) processing. enables electrophysiological investigations of the heart to be performed. The IECG module consists of electronic amplifiers and other signal processing devices. An IECG cable connects an intracardiac catheter (not covered by this submission) to the IECG system.

This document (K992948) describes a 510(k) premarket notification for the MAC-LAB System, a device intended for monitoring and recording cardiovascular data during cardiac catheterization.

Here’s a breakdown of the acceptance criteria and study information 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 the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Test Summary" only lists quality assurance measures and general testing without detailing patient-specific data or cohorts.

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

The provided text does not mention any expert review or establishment of ground truth for a test set in the context of clinical performance evaluation. The "Test Summary" focuses on internal development and verification processes rather than independent clinical validation with expert consensus.

4. Adjudication Method for the Test Set

The provided text does not describe any adjudication method. This type of detail is typically associated with clinical studies where independent reviewers resolve discrepancies in interpretations or diagnoses, which is not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, the provided text does not indicate that an MRMC comparative effectiveness study was done. The focus is on demonstrating substantial equivalence to predicate devices, not on comparing reader performance with and without AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The MAC-LAB System described is a comprehensive cardiac catheterization laboratory system that assists human healthcare practitioners. It is not a standalone algorithm in the sense of an AI-only diagnosis or measurement device. Its intended use is "under the direct supervision of a licensed healthcare practitioner," implying a human-in-the-loop system. The tests described are for the integrated system, not a decoupled algorithm.

7. The Type of Ground Truth Used

The provided text does not explicitly specify the type of ground truth used for performance evaluation in a clinical sense. Given that the device monitors and records various physiological data (ECG, heart rate, blood pressure, etc.) and performs calculations (valve gradients, cardiac output), the "ground truth" would likely involve comparison against:

• Reference standards for physiological measurements: e.g., precisely calibrated sensors or other established methods for measuring heart rate, blood pressure, oxygen saturation.
• Clinical expert interpretation: For waveforms and more complex analyses, though not explicitly detailed here.
• Predicate device output: The primary "ground truth" for demonstrating substantial equivalence seems to be the performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

The provided text does not mention any "training set." The MAC-LAB System, as described, appears to be a deterministic system for data acquisition, processing, and display, rather than a machine learning or AI-based system that undergoes a separate training phase with a distinct dataset.

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

Since there is no mention of a training set, the establishment of its ground truth is not applicable here.

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