(140 days)
The intended uses of the Quinton Model Q710 Exercise and Resting Electrocardiograph are acquisition, digitization, display, and recording of conventional diagnostic 12 simultaneous lead ECG waveforms and ECG data.
As an option, the Model Q710 has a resting ECG analysis program which makes measurements and provides interpretation of the ECG waveform for both adult and pediatric populations. This analysis program is offered to the physician on an advisory basis only and the physician is asked to overread and validate (or change) the ECG interpretation.
The Q710 Exercise and Resting Electrocardiograph records resting ECG data and provides a variety of user-selectable patient reports. When equipped with the optional exercise monitor, the system can be used for exercise stress testina.
A resting Interpretation option is also available that provides measurement and interpretive statements.
The device is made up of the Q710 electrocardiograph, optional CRT monitor, and cart option with a storage basket. The Q710 electrocardiograph includes an integral chart recorder, liquid crystal display (LCD), keyboard, and patient module which attaches to the patient cable. The electrocardiograph is a selfcontained unit, approximately 15 x 41 x 60cm in size, and housed within a polymeric enclosure.
Here's a breakdown of the acceptance criteria and study details based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence Study: Statistical equivalence between the Q710 and the Pagewriter XLi for ECG data presented digitally (specific statistical significance not detailed in the provided text). | Equivalence Study: All but one case out of 1047 test cases showed exact agreement between the Q710 and the Pagewriter XLi for ECG data presented to the software digitally. This "exceed[ed] the criteria that was established for statistical equivalence." |
| System Study: Demonstrate that both the Q710 and Pagewriter XLi systems perform equivalently with the resting interpretation option, specifically in: ECG acquisition capability.Identical data input by operator resulting in the same printed reports.Identical ECG data resulting in the same printed reports.Measurements and interpretive statements by an overreading physician for acquired ECG cases. | System Study: |
- Two minor defects were found in Q710 system software (not related to resting interpretation).
- These defects were corrected, and "certain tests were repeated."
- After correction, "all system study acceptance criteria [were] met." |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Equivalence Study Test Set: 1047 ECG cases.
- Provenance: The data was initially stored on a floppy disk and then "ported" to both devices, suggesting it was pre-existing data, thus retrospective. The country of origin is not specified but given the submitter's address in Washington, USA, it is likely US-based data.
- System Study Test Set: "A certain number of ECG cases" were acquired via ECG leads. The exact number is not specified, but it's stated that "certain tests were repeated" after defect correction. This implies prospective acquisition for these specific cases.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the Equivalence Study, the ground truth was based on the output of the predicate device (Hewlett Packard Pagewriter XLi). No human experts were involved in establishing "ground truth" for this comparison; it was a digital comparison between two algorithms' outputs.
- For the System Study, an "overreading physician" was used to compare and analyze the measurements and interpretive statements. The number of physicians is not specified (it states "an overreading physician," which could imply one or more). Their qualifications are not explicitly mentioned beyond being a "physician."
-
Adjudication method for the test set:
- Equivalence Study: "A PC based program compared the measurements and interpretive statements generated by each device for each case and noted any differences." This was an automated, direct comparison. No human adjudication method (like 2+1, 3+1) was described for this part.
- System Study: For the acquired ECG cases, results were "compared and analyzed by an overreading physician." This implies a qualitative human review, but a formal adjudication process (like 2+1 consensus) is not detailed.
-
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 comparative effectiveness study was not explicitly done. The study's primary goal was to demonstrate equivalence between the Q710 (which includes an interpretation algorithm) and a predicate device (also with an interpretation algorithm). While a physician "overread" the results in the system study, the study design does not appear to measure the improvement of human readers with Q710 assistance versus without it. The focus was on the equivalence of the interpretation algorithms themselves, with physician overread as a validation step for the system's performance.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone or algorithm-only comparison was a core part of the study, specifically the "Equivalence Study." In this study, ECG cases (stored digitally) were processed by both the Q710's algorithm and the Pagewriter XLi's algorithm, and their outputs were directly compared by a PC program. This represents a comparison of the algorithms' performance without human intervention in the interpretation process itself. The "resting Interpretation option" is described as providing "measurements and interpretive statements," which is the algorithm's output.
-
The type of ground truth used:
- Equivalence Study: The "ground truth" was effectively the output of the predicate device's algorithm (Hewlett Packard Pagewriter XLi). The goal was to show that the Q710's algorithm produced "exact agreement" with the predicate.
- System Study: For the acquired ECGs, the "ground truth" was established by comparison and analysis by an overreading physician against the outputs of both the Q710 and Pagewriter XLi. This indicates a form of expert review/consensus where the physician validates or identifies differences in the interpretations.
-
The sample size for the training set:
- Not specified. The provided text focuses entirely on the performance testing of the developed device and its equivalence to a predicate. It does not contain any information about the training set used for the Q710's resting interpretation algorithm.
-
How the ground truth for the training set was established:
- Not specified. As the training set size is not mentioned, neither is the method for establishing its ground truth.
N/A