(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: 1. Two minor defects were found in Q710 system software (not related to resting interpretation).2. These defects were corrected, and "certain tests were repeated."3. 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.
{0}------------------------------------------------
JUL 31 1996
510(k) SUMMARY
| Submitter's Name: | Quinton Instrument Company |
|---|---|
| Submitter's Address: | 3303 Monte Villa ParkwayBothell, Washington 98021-8906 |
| Submitter's Phone Number: | (US) 206-402-2000 |
| Submitter's Fax Number: | (US) 206-402-2017 |
| Contact Person: | Matt Hedlund |
| Date Summary Prepared: | June 3, 1996 |
A. Device Name and Classification
-
Device Trade Name Quinton Model Q710 Exercise and Resting Electrocardiograph
-
Device Common Name Electrocardiograph and ECG Analysis System
| 3) Device Classification Names | |
|---|---|
| 870.2340 | Electrocardiograph |
| 870.1425 | Programmable Diagnostic Computer |
| 870.2300 | Cardiac Monitor |
| 870.2370 | ECG Surface Electrode System |
| 870.2600 | Signal Isolation System |
| 870.2810 | Paper Chart Recorder |
| 870.1025 | Arrhythmia Detector and Alarm (Resting Interpretation Option) |
B. Predicate Device
The legally marketed device to which we claim equivalence is the Hewlett Packard Pagewriter XLi M1700A.
{1}------------------------------------------------
C. Device Description
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.
D. Intended Use of Device
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.
E. Summary of Technological Characteristics Compared with the Predicate Device
Both the Quinton Model Q710 and the Hewlett Packard Pagewriter XLi acquire. digitize, display, and record conventional diagnostic 12 simultaneous lead resting ECG waveforms and ECG data. As an option both devices have a resting ECG analysis and interpretation program covering adult and pediatric populations. The physical characteristics for both devices are approximately the same as each electrocardiograph has a built-in chart recorder, keyboard, and display panel contained within a unifed polymeric enclosure. Each device has rechargeable batteries for use when line power is not available. Optional carts are available for transporting the electrocardiographs.
{2}------------------------------------------------
E. Summary of Technological Characteristics Compared with the Predicate Device (Continued)
Differences between the devices include Pagewriter XLi's optional feature of displaying and/or recording signal averaginy ECG (SAECG) waveforms and data. Additionally, the Pagewriter XLi has a modem feature that the Q710 does not. The Q710 has a stress test option not available on the Pagewriter XLi that allows one to control exercise devices and employ specific exercise protocols from the Q710 while simultaneously recording 12 lead ECG data and displaying such data in a variety of reports. A CRT monitor is included in this option.
LI Performance Testing and Conclusions
-
- Performance Testing
Performance testing was made up of two parts, an equivalence study, and a system study. Both parts involved side-by-side comparisons of the Q710 and the Pagewriter XLi. In the equivalence study, a randomly selected number of ECG cases having sufficient statistical significance were stored on a floppy disk and ported to the Q710 and to the Pagewriter XLi. Measurements and diagnostic (interpretive) statements were generaled for each case by each electrocardiograph. These results were then ported via a floppy disk to a PC and stored on the PC. A PC based program compared the measurements and interpretive statements generated by each device for each case and noted any differences. In the system study paired comparisons of outputs from the Q710 and the Pagewriter XLi were made in three areas to demonstrate that as a system both systems perform equivalently with the resting interpretation option. One area compared the ECG acquisition capability of each device. Another area assessed whether identical data inputed by the operator and identical ECG data resulted in the same printed reports at each device. Finally a certain number of ECG cases were acquired via ECG leads by both devices and the data was processed resulting in measurements and interpretive statements that were printed as reports and compared and analyzed by an overreading physician.
- Performance Testing
{3}------------------------------------------------
F. Performance Testing and Conclusions (Continued)
2) Conclusions
All but one case out of 1047 tests cases in the equivalence study were shown to produce exact agreement between the Q710 and the Pagewriter XLi for ECG data presented to the software digitally. These results exceed the criteria that was established for statistical equivalence in the equivalence study protocol.
Two minor defects in Q710 system software were found during the system study testing. Neither defect was associated with the Q710 resting interpretation option software. After correction of these two defects certain tests were repeated rosulting in all system study acceptance criteria being met.
Taken together, the results of the equivalence study and the system study demonstrate that the Quinton Q710 with the resting interpretation option is substantially equivalent to the Hewlett Packard Pagewriter XLi.
N/A