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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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CardioSmart ST is intended to be used for resting and stress test ECG and for recording ECG in real-time without arrhythmia detection.
CardioSmart ST is intended to be used by trained operators when ECG records are required in the iudgment of a physician.
CardioSmart ST is not intended for use as a vital signs physiological monitor.
CardioSmart ST offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion.
CardioSmart ST is not designed for intracardial use.
CardioSmart ST is not intended for home use.

CardioSmart ST is a portable ECG data acquisition and recording system designed and manufactured by Marquette Hellige GmbH.
CardioSmart ST allows the user to

• record resting ECGs,
• i measure and interpret the ECGs,
• perform ECG stress tests.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CardioSmart ST device:

The provided 510(k) summary for the CardioSmart ST device, K973403, focuses heavily on demonstrating substantial equivalence to predicate devices rather than presenting specific quantitative acceptance criteria or a detailed clinical study for the CardioSmart ST itself.

The document emphasizes that:

• "CardioSmart ST hardware architecture is identical to the Technology predicate device CardioSmart."
• "All parts of the software which determine the medical functionality of the CardioSmart ST were re-used from the predicate devices."
• "The results of these measures demonstrated that CardioSmart ST is as safe, as effective, and performs as well as the predicate devices."

This indicates that the primary "proof" of meeting acceptance criteria for CardioSmart ST relies on its direct equivalence to legally marketed predicate devices (Marquette Hellige CardioSmart K950989, Marquette Hellige CardioSys K951130, and Marquette Responder 1500 K903644) and compliance with relevant industry standards.

Therefore, many of the requested details about a specific study may not be explicitly present for this particular device in this type of submission. The performance of the predicate devices would have undergone such studies.

Here's the information as extractable from the provided text, with explanations for missing points:

Acceptance Criteria and Reported Device Performance

Given that the submission relies on substantial equivalence and standard compliance rather than a novel clinical performance study for the CardioSmart ST, the "acceptance criteria" are implied to be compliance with the listed standards and equivalent performance to the predicate devices. No specific numerical performance metrics are provided for the CardioSmart ST itself in this document.

Study Details for CardioSmart ST

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

   • Not explicitly stated for the CardioSmart ST. The document describes "software and hardware testing, safety testing, environmental testing, final validation testing by an independent test group" as quality assurance measures, but does not provide details on the test set's size, origin, or nature (prospective/retrospective). This type of submission relies on the predicate having sufficient data, and the new device being substantially equivalent through engineering and design verification.

2. 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 explicitly stated for the CardioSmart ST. No mention of expert review for a specific ground truth test set for this device's submission.

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

   • Not applicable / Not stated. No clinical study involving expert adjudication of a test set is described for the CardioSmart ST.

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, an MRMC study was not done/described. The device is an ECG acquisition and interpretation system, but the submission does not detail a study on human reader improvement with its "interpretive statements." It explicitly states, "CardioSmart ST offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion."

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

   • Not explicitly stated. While the device includes an "optionally available analysis program" for interpretation, the submission does not detail a standalone performance study of this algorithm. The focus is on the device's overall safety and effectiveness as an ECG system, largely by comparison with predicates and compliance with standards.

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

   • Not applicable / Not explicitly stated for a clinical ground truth. For the validation and testing mentioned, the "ground truth" would likely be based on engineering specifications, reference ECG data (potentially from databases or simulations), and established clinical standards for ECG waveform characteristics, rather than a specific disease outcome or pathology in a clinical study context for a new algorithm.

7. The sample size for the training set:

   • Not applicable / Not stated for the CardioSmart ST. As the software was "re-used from the predicate devices" and no specific new algorithm development for CardioSmart ST is described, a training set for this specific submission is not relevant or mentioned. The training would have occurred for the predicate devices' algorithms.

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

   • Not applicable / Not stated for the CardioSmart ST. Similar to the point above, this information would pertain to the development of the algorithms in the predicate devices, not specifically for the CardioSmart ST submission itself.

Summary of Approach:

The K973403 submission for CardioSmart ST represents a common pathway for medical device clearance, particularly for devices with significant component re-use from established predicate devices. Instead of extensive new clinical trials with detailed performance metrics, the manufacturer demonstrated safety and effectiveness through:

• Substantial equivalence: Showing the device is essentially the same as already cleared devices.
• Compliance with recognized standards: Adhering to national and international standards for medical electrical equipment and ECG devices.
• Quality assurance measures: Implementing standard development and testing practices (requirements specification, design reviews, code inspections, software/hardware testing, safety/environmental testing, independent validation).

This approach means that the detailed clinical study information often sought for novel AI/ML devices is not typically present in such a 510(k) submission focused on equivalence.

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