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CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients.

The CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are designed to acquire, process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection.

The arrhythmia detection portion of CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but do not provide alarms.

CASE V7.0 Cardiac Testing System and Cardiac Testing System provide the control of external devices (typically a treadmill or bicycle ergometer) and communicate with centralized electronic/digital storage system via data networks.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System provide a user selectable option for printouts of prognostic scores on selected reports. Vector loops are also available.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System can be configured in a network environment for multiple CASE and CardioSoft stations allowing the user to create a central database of patient demographics and collected patient physiological data.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used primarily in the hospital but can also be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed.

CASE V7.0 Cardiac Testing System and Cardiac Testing System offer no diagnostic opinion to the user. Instead, it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion.

CASE V7.0 Cardiac Testing System and Cardiac Testing System are not intended to be used as a transport device or for home use.

CASE V7.0 Cardiac Testing System and Cardiac Testing System are not intended for use as a vital signs physiological monitor.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for intracardiac use.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use as an emergency device.

CASE V7.0 Cardiac Testing System and Cardiac Testing System will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulators.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use with high frequency surgical units. Disconnect the patient from CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System before using the high frequency surgical unit.

The CASE V7.0 Cardiac Testing System and the CardioSoft V7.0 Cardiac Testing System are designed to be used for resting ECG, stress test ECG, Spirometry, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CardioSoft V7.0 Cardiac Testing System will be offered as a software only package including a front end for data acquisition. The CASE V7.0 Cardiac Testing System is a turnkey product utilizing the CardioSoft V7.0 Cardiac Testing software.

This FDA 510(k) summary provides information for the CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System. However, it does not contain specific acceptance criteria, reported device performance metrics tied to those criteria, or a detailed study description with sample sizes, expert qualifications, or ground truth methods related to the device's diagnostic or analytical capabilities.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (CASE Cardiac Testing System, CS Cardiac Testing System (K103678)) by comparing features and functions. It mentions compliance with performance standards but does not detail the results of performance tests in terms of specific metrics for the device itself.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's what can be gathered, addressing the points where information is available or noting its absence:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria with corresponding reported device performance metrics for diagnostic accuracy, sensitivity, specificity, or other analytical capabilities. Instead, it compares the proposed device's features and technical specifications to those of the predicate device, asserting "Identical" or "Equivalent" for most technical aspects.

For example, under "ECG Signal Bandwidth", the proposed device has "0.04 to 150 Hz (CC14)" compared to the predicate's "0.01 to 150 Hz (CAM 14)". The explanation notes that the proposed device complies with IEC60601-2-25:2011 requirement of 0.67 Hz to 150 Hz, implying that 0.04 Hz is within acceptable limits for capturing useful ECG data. This is a comparison to a standard, not a specific performance metric of the device against an internal acceptance criterion.

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

This information is not provided in the document. The submission states, "The subject of this premarket submission, CASE V7.0 and CardioSoft V7.0 did not require clinical studies to support substantial equivalence." This indicates that no new clinical study was conducted for this 510(k) submission to demonstrate performance with a test set of patient data.

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)

This information is not provided as no new clinical study (test set evaluation) was detailed.

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

This information is not provided as no new clinical study (test set evaluation) was detailed.

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 mentioned or performed for this submission, as it explicitly states no clinical studies were required. The device provides "interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion," implying human-in-the-loop, but the submission doesn't detail performance with or without AI assistance.

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

A standalone performance study of the algorithm (e.g., for arrhythmia detection or ECG analysis) was not detailed as part of this submission. The "arrhythmia detection portion" is described as being "provided to the user for the convenience of automatic detection of arrhythmias but do not provide alarms." The 12SL ECG Analysis Program (V23) is mentioned, which is a previously cleared component (K141963), suggesting its performance was established in its own clearance.

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

This information is not provided as no new clinical study (test set evaluation) was detailed.

8. The sample size for the training set

This information is not provided. The document describes upgrades to existing software and hardware components and relies on compliance with voluntary standards and substantial equivalence to a predicate device. There is no mention of a new "training set" in the context of machine learning, although software development would involve internal testing.

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

This information is not provided. As above, there's no mention of a new training set or ground truth establishment. The device incorporates a "12SL ECG Analysis Program (V23) (K141963)" which would have had its own ground truth established during its prior clearance.

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EK12 V2 analyzes 10 or more seconds of a previously acquired electrocardiogram (ECG) from physiological ECG signal recording devices for rhythm and measurements.
EK12 is used to create reports intended for use by a Qualified Medical Professional, including a trained ECG Technician operating within Independent Diagnosic Testing Facility (IDTF) requirements and performance standards for the review and assessment of an ECG.
EK 12 V2 is indicated for use on adults and pediatric patients older than 2 years. The device is intended for use in an IDTF or a professional medical facility, such as a hospital, clinic, or physician's office.

EK12 V2 algorithm is a software only product that provides computerized measurements from the ECG parameter data acquired by the host device. EK12 V2 analyzes ECG recordings for rhythm and measurements that is deployed as part of a host system used to generate ECG reports

Here's a breakdown of the acceptance criteria and study information for the EK12 V2 Algorithm, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics from a study. Instead, it states that "The EK12 V2 Algorithm complies with the voluntary consensus standard AAMI/ANSI EC57: 2012 – Testing And Reporting Performance Results Of Cardiac Rhythm and St-Segment Measurement Algorithms."

This implies that the acceptance criteria are the performance requirements outlined in the AAMI/ANSI EC57: 2012 standard for cardiac rhythm and ST-segment measurement algorithms. The document then asserts that the device meets these criteria by stating its compliance. However, specific numerical performance results against these criteria are not provided within the given text.

Therefore, a direct table cannot be constructed with numerical performance. The closest interpretation based on the provided text would be:

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

The document states: "The EK12 V2 Algorithm program was designed for compliance with applicable clauses of the following voluntary standard: AAMI/ANSI EC57: 2012 – Testing And Reporting Performance Results Of Cardiac Rhythm and St-Segment Measurement Algorithms."

However, the provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) of the data used for the "Performance testing" mentioned.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications for the test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers with and without AI assistance.

6. Standalone Performance Study

The document implies that standalone performance testing was conducted. It states, "Performance testing" was a quality assurance measure applied to the development of the system and that "The EK12 V2 Algorithm program was designed... for compliance with applicable clauses of the following voluntary standard: AAMI/ANSI EC57: 2012 – Testing And Reporting Performance Results Of Cardiac Rhythm and St-Segment Measurement Algorithms." This suggests that the algorithm itself was tested against the standard.

However, specific results of this standalone performance are not detailed beyond the statement of compliance.

7. Type of Ground Truth Used

While the standard AAMI/ANSI EC57: 2012 typically involves a precise "ground truth" derived from expert review or more invasive methods for rhythm and ST-segment identification, the document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the testing of EK12 V2.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set.

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

The document does not provide information on how the ground truth for the training set was established.

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The MAC VU360 Resting ECG Analysis System is a non-invasive prescription device.
-The device is indicated for use to acquire, analyze, display and print electrocardiograms.
-The device is indicated for use to provide interpretation of the data for consideration by a physician.
-The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
-The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data.
-The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.

The MAC VU360 Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The MAC VU360 can capture 3, 6, 12, or 15 lead electrocardiograms, provide interpretive analysis, and print reports. The MAC VU360 is indicated for use on adult and pediatric (birth through 21 years of age) populations. The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with the cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow. The device can also optionally display data from external systems which provide web or Citrix content. The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via a wheeled trolley. The MAC VU360 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the MAC VU360 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size. The MAC VU360 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

The provided text does not contain detailed information about a study proving the device meets specific acceptance criteria with a table of performance metrics, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document is a 510(k) summary for the MAC VU360 Resting ECG Analysis System. It primarily focuses on demonstrating substantial equivalence to a predicate device (ELI 380 Resting Electrocardiograph), rather than presenting a performance study with detailed acceptance criteria and results.

Here's what can be extracted and what is not available based on the provided text:

Acceptance Criteria and Device Performance:

The document states "The subject of this premarket submission, MAC VU360 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence." This implies that the acceptance criteria for this submission were primarily based on technological similarity to the predicate device and compliance with voluntary standards, rather than a clinical performance study with defined quantitative metrics.

Therefore, a table of acceptance criteria and reported device performance, as requested, cannot be generated from the provided text because such a study was not deemed necessary for substantial equivalence in this context.

Other Information:

1. Sample sizes used for the test set and the data provenance: Not applicable, as no dedicated clinical performance test set is described. The device's performance is asserted through its use of the 12SL Algorithm, which is referenced as being used by a reference device (MAC 5500 HD), implying its prior validation. Data provenance is not specified beyond "adult and pediatric (birth through 21 years of age) populations" for intended use.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth establishment for a specific test set is described for performance evaluation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. The device provides "interpretation of the data for consideration by a physician" and states that "The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data." This suggests a human-in-the-loop use case, but no MRMC study is detailed to quantify improvements.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states, "The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data." and "It is not intended as a sole means of diagnosis." This indicates it's designed for human-in-the-loop, and a standalone performance study is not described.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no specific performance study requiring ground truth is detailed. The device relies on the established 12SL Algorithm.

7. The sample size for the training set: Not applicable. The document states the device "utilizes the 12SL Algorithm," implying that the algorithm's training (if any was needed) was done previously and is not part of this submission's new data.

8. How the ground truth for the training set was established: Not applicable, as no specific training set or its ground truth establishment is described for this submission. The 12SL Algorithm is a pre-existing component/technology.

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