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CardioSoft/CASE Cardiac Testing System is intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CardioSoft/CASE Cardiac Testing System is 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 CardioSoft/CASE Cardiac Testing System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.
CardioSoft/CASE Cardiac Testing System provides the control of external device (typically a treadmill or Ergometer) and communicates with centralized electronic/digital storage system via network. CardioSoft/CASE Cardiac Testing System provides a user selectable option for printouts of prognostic scores on select reports. Vector loops are also available.
CardioSoft/CASE 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.
CardioSoft/CASE Cardiac Testing System is intended to be used primarily in the hospital but can be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed.
CardioSoft/CASE Cardiac Testing System offers 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.
CardioSoft/CASE Cardiac Testing System is not intended to be used as a transport device or for home use. CardioSoft/CASE Cardiac Testing System is not intended for the use as a vital signs physiological monitor or for intracardiac use.

The CardioSoft/CASE Cardiac Testing System is designed to be used for resting ECG, stress test ECG, Spirometery, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CardioSoft will be offered as a software only package including a front end for data acquisition.
The CASE is a turnkey product utilizing the CardioSoft software. The CASE device is designed for the US markets. A version designed for the European market, the CardioSys, will not be offered for sale in the US.

The CardioSoft/CASE Cardiac Testing System is described as substantially equivalent to predicate devices based on safety and performance, but specific acceptance criteria and detailed device performance metrics are not explicitly provided in the furnished text.

Here's an breakdown of the information that can be extracted, and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

This information is not available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not available in the provided text.

4. Adjudication method for the test set:

This information is not available in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

This information is not available in the provided text.

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

The device is an "ECG Analysis Computer" and provides "interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion." It also has "arrhythmia detection provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms." This suggests a standalone component (the algorithm/software) is present, but a formal standalone study proving its performance in isolation is not detailed or explicitly stated. The overall statement is that the system is as safe and effective as the predicate.

7. The type of ground truth used:

This information is not available in the provided text. The submission refers to a "Test Summary" but does not elaborate on the ground truth used for performance evaluation.

8. The sample size for the training set:

This information is not available in the provided text.

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

This information is not available in the provided text. The document outlines "quality assurance measures" such as "Requirements specification review," "Code inspections," "Software and hardware testing," "Safety testing," "Environmental testing," and "Final validation," but these do not detail how ground truth was established for any training data.

Summary of the Study Discussed (as per the available text):

The document references a "Test Summary" that states, "The CardioSoft/CASE Cardiac Testing System complies with the voluntary standards as detailed in Section 9 of this submission." It further states, "The following quality assurance measures were applied to the development of the system: Requirements specification review, Code inspections, Software and hardware testing, Safety testing, Environmental testing, Final validation."

The conclusion from these "measurements" (which are not detailed) is that "The results of these measurements demonstrated that the CardioSoft/CASE Cardiac Testing System is as safe, as effective, and performs as well as the predicate device."

Key Take away: This 510(k) summary focuses on demonstrating substantial equivalence through a general assertion of safety and effectiveness compared to predicate devices, supported by a list of quality assurance measures. It does not provide the granular detail typically found in a clinical study report regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, or ground truth methodologies. This type of submission relies more on demonstrating that the new device uses similar technology, has similar intended use, and has undergone standard development and testing procedures to ensure it is "as safe, as effective, and performs as well" as previously cleared devices.

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