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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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