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· The System is intended to derive, display and print a derived 12 lead ECG as well as the X, Y, Z leads from the acquisition of just 3 leads (5 electrodes).The System also has the capability to acquire the standard 12 lead ECG using the standard 10 electrodes and convert the ECG signal into a digital format.

· The 12 lead interpretive software is a windows-based program intended to interpret electrocardiograms. The software receives, displays and stores a single, three or standard 12 lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from an ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze and interpret the 12 lead ECG signal only.

· In 5 electrode mode, the System analyzes data from 3 leads (5 electrodes) and produces visual and audible alarms for ECG changes that may be consistent with 12-lead ECG signs of Acute Myocardial Ischemic Injury (AMII), including Acute Myocardial Infarction (AMI).This mode is not intended to be a sole means of diagnosis, but prompts, the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician when the Cardian Electrical Biomarker (CEB®) is 95 or greater. Monitoring patients with a CEB® is only indicated for patients presenting with chest pain or other presumed anginal equivalents.

· The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes.

· The System is intended to be used by healthcare professionals, or trained personnel where ECG monitoring /acquisition is indicated for hospitals and/or clinics.

· The System can be used within electro-surgical environments.

· Device is for Adult use.

The Universal SmartECG is a device with 10 lead wires attaching to electrodes on a patient's chest and one wire connecting to a computer. The system is able to display, store, and print a 12 lead ECG with 10 electrodes attached to the patient. In addition, The Universal SmartECG incorporates the VectraplexECG software (K102378), to derive up to a 15 lead (standard 12 leads and Frank vector X, Y, and Z leads) ECG from only three measured leads (5 electrodes). The device also monitors, in real-time, ECG changes that may be indicative of acute myocardial ischemic injury, including AMI*, via a displayed index number, the Cardiac Electrical Biomarker (CEB; VectraplexAMI). The system also provides the vector loops. The System's derivation algorithm is able to provide additional information based on geometric principals relating to the placement of electrodes on the body. The Cardiac Electrical Biomarker (CEB) is produced based on an algorithm accounting for the multipolar contributions of the electrical field around the heart, which was FDA cleared via K102378.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the Universal SmartECG, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with specific performance metrics against pre-defined acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred, with limitations noted due to the nature of the document:

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

The document states that the new hardware device, the Universal SmartECG, "has been tested to, and passed. 60601-1.-1-2. and 2-25 standards." This implies that the device met the performance requirements of these electrical safety and essential performance standards. However, specific performance metrics (e.g., sensitivity, specificity, accuracy for disease detection) and their acceptance thresholds are not explicitly stated or quantified in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "Since this update is not changing the CEB algorithm or the derivation algorithm from the VectraplexECG System it has been determined that no clinical data is necessary to support these functions." This implies that no new clinical test set data was collected for this specific 510(k) submission to demonstrate the performance of the CEB algorithm or the derived ECG. The assessment was based on the fact that existing, previously cleared algorithms and functionalities were not altered in a way that would necessitate new clinical validation for their core performance.

Therefore, sample size, data provenance, retrospective/prospective nature for clinical performance is not applicable to this specific submission. Any previous clinical studies for the predicate device (K102378) would have contained this information.

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, as no new clinical test set data was collected for this submission. The effectiveness of the CEB® algorithm was previously established during the K102378 submission.

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

Not applicable, as no new clinical test set data was collected for this submission.

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

Not applicable to this 510(k) submission, as it focuses on demonstrating substantial equivalence of an updated system rather than new clinical effectiveness. The CEB® mode is described as "not intended to be a sole means of diagnosis, but prompts, the user to acquire a standard 12 lead ECG... for interpretation by a physician." This suggests an assistive role, but no MRMC study details are provided in this document.

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

This document does not specify a standalone performance study. The device's CEB® algorithm is designed to alert users, prompting further physician interpretation. Its performance without human interpretation is integral to its function, but specific standalone metrics are not provided in this summary.

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

Not applicable to this specific submission for new clinical data. For the original clearance of the CEB® algorithm (K102378), the ground truth for Acute Myocardial Ischemic Injury (AMII) and Acute Myocardial Infarction (AMI) would typically involve a combination of:

• Clinical diagnosis: based on patient symptoms, cardiac enzymes (e.g., troponin levels), and serial ECG changes interpreted by cardiologists.
• Outcomes data: confirming a myocardial infarction event.

8. The sample size for the training set

The document does not provide information about the training set size for the algorithms within the Universal SmartECG. This information would have been part of the previous 510(k) for the VectraplexECG System (K102378), which included the CEB® algorithm.

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

Not provided in this document. Similar to point 7, the ground truth for the training set of the CEB® algorithm (from K102378) would have been established through a combination of clinical diagnosis, cardiac biomarker levels, and expert cardiologist interpretation.

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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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