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The MobileECG System is intended to provide an interpretation of the resting 12 lead ECG in all situations, whether in a hospital or primary care setting. It is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction (MI), including acute MI, ventricular hypertrophy, abnormal ST-T changes and common abnormalities of rhythm.

The MobileECG System is intended for use in adults and children of any age from birth upwards.

The MobileECG System's interpretation software is not intended as sole means of diagnosis and is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.

The MobileECG System is an electrocardiograph consisting of Model 950-12LR HHC module and CardioVu interpretation software.

The Model 950-12LR HHC module is a small, light weight, single battery, wireless module designed to transmit 12Lead electrical heart activity of a patient to a computer. This module will transmit a patient's ECG wirelessly to a laptop, netbook, tablet, or desktop computer containing the CardioVu interpretation software from up to 100 feet away.

Elimination of the cable reduces a source of artifact resulting in high-quality ECG tracings. Wireless dedicated and secure communication links the Model 950-12LR HHC module to CardioVu interpretation software.

The CardioVu software receives, displays, and stores the patients ECG data wirelessly on a laptop, netbook, tablet, or desktop computer in "real time". The software also has the data using ECG algorithms for review by a physician or other qualified medical professional as an advisory basis only in conjunction with the physician's knowledge of ECG. The wireless feature allows the patient not to be tethered to the computer or a bulky box thus reducing motion artifacts caused by movement of the connecting cables and providing comfort to the patient.

The provided 510(k) summary for the Memtec Corporation's MobileECG System (K103427) does not describe an extensive study (clinical or analytical) with specific acceptance criteria and performance metrics for the device's diagnostic capabilities. Instead, it focuses on non-clinical testing for substantial equivalence to predicate devices based on applicable standards.

Therefore, many of the requested details about acceptance criteria, study sizes, expert qualifications, and ground truth establishment cannot be extracted from this document as such a study is not presented.

Here's a breakdown of what can be inferred from the document regarding comparative effectiveness and analytical performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity) for its ECG interpretation software. The assessment is based on demonstrating equivalence to predicate devices through compliance with technical standards.

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

No clinical test set is described. The "non-clinical tests" focused on standards compliance, not diagnostic performance on a patient dataset.

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

Not applicable, as no clinical test set with expert-established ground truth is described. The software's interpretation is "an advisory basis only in conjunction with the physician's knowledge of ECG."

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set for diagnostic performance 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:

No MRMC study is mentioned. The device's software is described as providing "interpretation software... on an advisory basis only," suggesting it's an aid, but no study on human performance improvement with this aid is presented.

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

The document states, "The software also has the data using ECG algorithms for review by a physician or other qualified medical professional as an advisory basis only." While algorithms are present, a formal standalone performance study (e.g., sensitivity/specificity of the algorithm alone against a gold standard) is not described or quantified in this 510(k) summary.

7. The Type of Ground Truth Used:

Not applicable, as a study requiring ground truth for diagnostic performance is not described.

8. The Sample Size for the Training Set:

The document does not provide any information about a training set for the ECG interpretation algorithms.

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

Not applicable, as no training set or its ground truth establishment is described.

Summary of what the 510(k) does convey:

The document primarily demonstrates substantial equivalence to predicate devices through non-clinical testing against relevant industry standards (e.g., electrical safety, electromagnetic compatibility, ECG performance requirements like filtering and lead accuracy). It asserts that the device's technical specifications and intended use are similar to those of previously cleared devices, making it equally safe and effective from a manufacturing and functional standpoint, rather than providing a detailed clinical validation of its diagnostic algorithm's accuracy.

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