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QT Guard Plus Analysis System is intended to be used in a hospital, clinic or research environment by competent health professionals. QT Guard Plus Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECGs for obtaining the measurement of QT interval dispersion and T wave complexity. QT Guard Plus Analysis System is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended to produce any interpretation of those measurement or diagnosis. The QT dispersion and T wave complexity measurements produced by QT Guard Plus Analysis System are intended to be used by qualified personnel in evaluating ECG data and the patient in conjunction with patient's clinical history, symptoms other diagnostic tests, as well as the professional's clinical judgment. QT Guard Plus Analysis System is intended for adult patient populations.

QT Guard Plus is a software program that runs on a Microsoft Windows PC-based platform and utilizes 12 lead data from GE's 12SL ECG Analysis Program (K092369) to measure QT and T Wave measurements for clinical or scientific investigation. The program analyzes simultaneously acquired digital 12 lead ECGs that have been previously acquired by other ECG acquisition and storage devices. QT Guard Plus does not directly acquire data from a patient. The program has a user interface that displays the ECG along with the measurements generated by the program. These measurements can be modified via the user interface.

The provided text, a 510(k) Premarket Notification Submission for the GE Healthcare QT Guard Plus Analysis System, states that no clinical studies were required to support substantial equivalence, and therefore, no specific acceptance criteria or study demonstrating device performance against such criteria are explicitly detailed in this document.

The submission focuses on establishing substantial equivalence to predicate devices (K981024; QT Dispersion and T Wave Analysis Program (QT-Guard Analysis System) and K072502 MUSE Cardiology Information System) based on fundamental scientific technology and non-clinical tests.

However, I can extract the information provided about the development and testing that was performed:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical studies or specific quantitative acceptance criteria are presented in this document, a table correlating acceptance criteria with reported device performance cannot be generated based on the provided text. The document states:
"There are no recognized consensus standards applicable to QT Guard Plus Analysis System. QT Guard Plus and its applications comply with the Guidances and/or Special Controls as detailed in Section 9 of this premarket submission."
And later, under "Summary of Clinical Tests":
"The subject of this premarket submission, QT Guard Plus did not require clinical studies to support substantial equivalence."

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

Not applicable. No clinical test set data is provided or referenced in this document. The submission explicitly states that clinical studies were not required.

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

Not applicable. No clinical test set and thus no ground truth established by experts is mentioned.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set is mentioned.

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

Not applicable. No clinical efficacy study comparing human readers with and without AI assistance is mentioned.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study of the algorithm (QT Guard Plus) was conducted, but it was non-clinical. The "Summary of Non-Clinical Tests" states that "Performance testing" was applied to the development of the system. However, specific results, metrics, or the dataset used for this performance testing are not detailed in this 510(k) summary.

7. Type of Ground Truth Used:

For the non-clinical "Performance testing," the type of ground truth used is not specified. Given the nature of an ECG analysis program, it's highly probable that the ground truth for this internal performance testing would be derived from precisely measured intervals by expert cardiologists or a gold standard reference method applied to a dataset of ECGs. However, this is not explicitly stated.

8. Sample Size for the Training Set:

Not applicable. The document does not provide information on a training set as it refers to a software component that performs measurements rather than a machine learning model that would typically require a training set. The device is described as "a software program that runs on a Microsoft Windows PC-based platform and utilizes 12 lead data from GE's 12SL ECG Analysis Program (K092369) to measure QT and T Wave measurements." This suggests an algorithmic approach rather than a data-driven machine learning approach that requires a distinct training set.

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

Not applicable, as no training set is mentioned for this device.

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