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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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The Marquette Eagle 4000 Patient Monitor is designed to monitor and display patient data. Its design allows the operator to adjust parameter alarm settings that would audibly and visually notify the operator when a violation occurs. The option is provided for printing of information by a paper recorder. Use of the Marquette Eagle 4000 Patient Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal. Use of the Marquette Eagle 4000 Patient Monitor is not recommended for use in patient's home or residence, during patient transport, or when it has not been ordered by a physician or other qualified medical personnel. Use of the Marquette Eagle 4000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.

The Marquette Eagle 4000 Patient Monitor is a patient monitoring system that is designed to be used to monitor a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, respiration, apnea detection, pulse rate, cardiac output, and full arrhythmia analysis. The device now includes Marquette's 12 lead ECG Analysis program (commonly referred to as 12 SL).

The provided text is a 510(k) summary for the Marquette Eagle 4000 Patient Monitor, dated February 2, 1997. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than conducting a detailed performance study with specific acceptance criteria and detailed quantitative results as might be found in a modern clinical trial or a more recent AI/ML device submission.

Therefore, much of the requested information cannot be extracted directly from this document because it predates the rigorous, quantitative evaluation standards common for AI/ML medical devices today. The summary primarily relies on a general statement of "verification and validation testing" and "accuracy requirements as specified in the contents of the premarket notification submission" without detailing the specifics of these tests or their results.

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

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

• Acceptance Criteria: Not explicitly stated in a quantifiable way in this summary. The summary broadly states that "Test results indicate that the Eagle 4000 Patient Monitor provides an equivalent level or better in performance, when compared to the legally marketed predicate devices when tested to the accuracy requirements as specified in the contents of the premarket notification submission." The "accuracy requirements" themselves are not provided.
• Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, error rates) are reported 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)

• Sample Size: Not specified.
• Data Provenance: Not specified.

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 specified. The document does not describe the establishment of ground truth by independent experts in a test set, as would be common for AI/ML devices. The "verification and validation testing" likely refers to internal engineering and clinical validation testing against established standards or predicate device performance.

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

• Not applicable/Not specified. There is no mention of an adjudication process for a test set.

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

• No. This type of study (MRMC for AI assistance) is not mentioned and is highly unlikely given the device type (patient monitor) and the era (1997). The device provides physiological parameter monitoring and 12-lead ECG analysis, but there's no indication of it being an AI-assisted diagnostic tool that would improve human reader performance in the modern sense.

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

• Yes, implicitly. The performance evaluation would inherently be of the device's algorithms and hardware alone, as it's a patient monitor providing data and analysis. The "verification and validation testing" would assess the accuracy of its measurements and analyses (e.g., ECG, blood pressure, arrhythmia detection) as a standalone system. However, specific results are not provided.

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

• Not explicitly defined in the summary. For a patient monitor, ground truth would typically involve:
  • Reference Devices: Comparing measurements against highly accurate, calibrated reference instrumentation (e.g., for blood pressure, temperature, oxygen saturation).
  • Validated ECG Databases: For the "12 SL" ECG analysis program, ground truth might involve comparisons against widely accepted ECG databases with expert-adjudicated diagnoses, though this is not stated.
  • Clinical Observation: For arrhythmia detection, comparison against expert interpretation of concurrent ECG recordings.
• The summary only broadly refers to "accuracy requirements as specified in the contents of the premarket notification submission."

8. The sample size for the training set

• Not applicable/Not specified. The document does not mention "training sets" as it would for a machine learning device. The ECG analysis program would have been developed using a dataset, but it's not characterized as a "training set" in the context of modern ML.

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

• Not applicable/Not specified. As no "training set" is described, its ground truth establishment is not discussed.

In summary, the provided 510(k) summary from 1997 is a regulatory declaration of substantial equivalence for a patient monitor and does not contain the detailed performance study information, acceptance criteria, or ground truth methodologies that are now standard for AI/ML device submissions. The document's purpose is to demonstrate that the Eagle 4000 is as safe and effective as its predicate devices based on general verification and validation testing, without providing the quantitative specifics you've requested.

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