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EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates. ST. Segment monitoring is restricted to adult patients only.

EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms, including:

• Assessment of symptoms that may be related to rhythm disturbances of the heart
• -Patients with palpitations
• The evaluation of arrhythmias in patients from neonatal to pediatric to adult age
• arrhythmia
• -- Assessment of efficacy of anti-arrhythmic therapy
• -- Assessment of pacemaker function
• Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmia analysis during exercise testing

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The provided text describes the 510(k) summary for the EASI ECG device (K033513). However, it is very brief regarding detailed acceptance criteria and study particulars. Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 1185 patients.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data is referred to as a "database."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Not specified. The text only mentions "comparison of results to the predicate and direct ECG."

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

• No, an MRMC comparative effectiveness study is not mentioned. The comparison was primarily against a predicate device and "direct ECG."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, the performance verification involved the device (EASI ECG) being compared to "direct ECG" and a "predicate" algorithm/device. This implies a standalone evaluation of the EASI ECG algorithm's output.

7. The Type of Ground Truth Used

• The "ground truth" for the test set appears to be derived from a "direct ECG." This suggests a reference standard obtained by conventional, established ECG recording methods.

8. The Sample Size for the Training Set

• Not specified. The document only mentions the test set of 1185 patients.

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

• Not specified, as the training set details are not provided.

Summary of Limitations in the Provided Information:

The 510(k) summary provided is very high-level and lacks specific details regarding:

• The exact "Pass/Fail criteria" for substantial equivalence.
• The specific metrics used for comparison (e.g., accuracy, sensitivity, specificity for arrhythmia detection or ST segment analysis).
• Details on the "direct ECG" used as a reference.
• The nature of the "database" of 1185 patients (e.g., demographics, disease prevalence, data collection method).
• Any details about the training data or how its ground truth was established.
• The role of human experts in establishing ground truth for either the training or test sets.

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Assessment of real time ST segment analysis in adult patients. Assessment is indicated for the hospital environment.

The new device is a modification to previously reviewed submittals containing the EASI algorithm. The modification is a software-based change that slightly improves existing correlation coefficients. The modification also allows reconstruction to simulate a Mason Likar lead placement.

Acceptance Criteria and Device Performance

Study Information:

1. Sample size used for the test set and the data provenance: Not explicitly stated but the text mentions "earlier studies on the same patients" when discussing the comparison of correlation coefficients, implying a retrospective analysis of existing data. The number of patients in these "earlier studies" is not specified. The country of origin of the data is not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "2 physician over-reads" were involved in comparing the modified coefficients to traditional 12-Lead ECG and Mason Likar 12-Lead ECG. Their specific qualifications are not detailed beyond "physician."
3. Adjudication method for the test set: Not explicitly stated. The text mentions "2 physician over-reads comparing the modified coefficients," but does not clarify if there was a formal adjudication process if the physicians disagreed.
4. 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 was not a comparative effectiveness study involving human readers. The study focused on the performance of the algorithm itself in terms of correlation coefficients.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the study primarily evaluated the standalone performance of the algorithm's modified coefficients by comparing them to established ECG standards. The "2 physician over-reads" serve as a form of validation against human interpretation of established methods, but the core performance metric (correlation coefficient) is algorithmic.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth was established by "traditional 12 Lead ECG and Mason Likar 12 Lead ECG" which were then reviewed by "2 physician over-reads." This implies a form of expert consensus based on established clinical methods.
7. The sample size for the training set: Not specified. The document only refers to "earlier studies on the same patients" for validation, without detailing a separate training set.
8. How the ground truth for the training set was established: Not specified, as details about a distinct training set are absent. It can be inferred that the ground truth for any underlying algorithm development would have been established using similar methods (traditional ECGs and expert interpretation) as those used for validation.

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