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QT Guard Analysis System is intended to be used in a hospital or clinic environment by competent health professionals.

QT Guard Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECG for obtaining the measurements of QT interval dispersion and T wave complexity.

QT-Guard Analysis Program 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 measurements or diagnosis.

The QT dispersion and T wave complexity measurements produced by QT Guard Analysis System are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment.

QT Guard Analysis System is intended for adult patient populations.

QT Guard Analysis System is a software program for measuring the QT interval dispersion and T wave complexity from simultaneously acquired 12-lead ECG.

The provided text is a 510(k) summary for the "QT Dispersion and T wave Analysis System (QT Guard Analysis System)". It states that the device is substantially equivalent to a predicate device, the Marquette 12SL Analysis Program, based on quality assurance measures and laboratory tests. However, it does not provide detailed acceptance criteria or a comprehensive study report with specific performance metrics as requested.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for a test set or the data provenance. It mentions "laboratory tests" but does not elaborate on their methodology or the data used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The comparison is made against a predicate device, and it's not clear how "ground truth" was established for any internal testing, if any such concept was even applied in a formal way beyond comparing outputs to the predicate.

4. Adjudication method for the test set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or implied. The device is for analysis of ECGs to provide measurements, not for assisting human readers in interpretation or diagnosis.

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

Yes, the testing described appears to be a standalone assessment of the algorithm's performance. The statement "The results of these measurements demonstrated that QT Guard analysis is as safe, as effective, and performs as well as the predicate device" refers to the system itself, without human intervention in its primary function of generating measurements.

7. The type of ground truth used

The concept of "ground truth" in the typical sense (e.g., pathology, outcomes data, or expert consensus on clinical diagnoses) is not directly applicable or explicitly stated in the context of this submission. The device provides measurements of QT interval dispersion and T wave complexity. The "truth" in this context would likely be the correctness and consistency of these measurements when compared to the predicate device, or possibly to known physiological standards, though the latter is not detailed. The submission relies on comparison to a predicate device (Marquette 12SL Analysis Program) as the basis for establishing substantial equivalence for its performance.

8. The sample size for the training set

The document does not specify a training set or its sample size. As a 510(k) submission for substantial equivalence, the focus is on demonstrating similar performance to an existing device, rather than detailing the development and training of a new AI model in the contemporary sense.

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

This information is not provided, as a training set is not discussed.

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