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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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