(259 days)
The intended use of the Quinton Synergy Cardiology Information System (CIS) is the acquisition, storage, and display of electrical signals of biological origin, as ECG data, that are obtained from other devices connected directly to the patient. This display on the CIS would only occur at the cessation of data acquisition by the patient connected equipment. (Hence, the CIS would only operate as non-real time system.) Additionally, the CIS may acquire, store, and display administrative data, as patient demographic information.
Acquired information may be reviewed, edited, abridged, or re-formatted and distributed electronically or printed.
The CIS is a cardiology data management system that encompasses and integrates proprietary software and third party software on a single workstation or networked workstations. The workstation may include ancillary devices as a server, bar cod system, and printer.
The CIS provides a means to establish, maintain, access, review, and edit cardiology patient records that are typically generated from ECG procedures.
The Quinton Synergy Cardiology Information System (CIS) is a cardiology data management system that acquires, stores, and displays electrical signals of biological origin (ECG data) obtained from other connected devices, as well as patient demographic information.
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the Quinton Synergy Cardiology Information System (CIS) were implicitly demonstrated through performance testing comparing data integrity and visual assessment of ECG and textual information. The reported device performance met these criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Integrity of Digital ECG and Textual Data Transfer (Q710 to CIS): No differences between pre and post-transmitted digital data | Met: "No differences were found in the digital comparison between pre and post transmitted data from the Q710 to the CIS." |
| Integrity of Digital ECG and Textual Data Transfer (HP PageWriter XLi to CIS): Expected differences due to communication protocol | Met: "Only expected differences were found during the digital comparison of pre and post transmitted data from the HP PageWriter XLi to the CIS. These differences are due to the HP communication protocol not transmitting certain fields." |
| Visual Integrity of Printed ECG and Textual Data (Q710 to CIS): No significant differences identified by a cardiologist | Met: "no significant differences were found by the cardiologist when comparing the pretransmission print-outs from the Q710 with the post-transmission print-outs at the CIS." |
| Visual Integrity of Printed ECG and Textual Data (HP PageWriter XLi to CIS via floppy disk): No significant differences identified by a cardiologist | Met: "no significant differences were found in the PageWriter transfer test using a floppy disk." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample size for the test set (number of ECG waveforms or textual data transmissions). However, it mentions "randomized ECG waveforms and textual data."
The data provenance is from existing devices for which the CIS is receiving data: the Quinton Model Q710 Exercise and Resting Electrocardiograph and the HP PageWriter XLi. The study appears to be retrospective in the sense that it uses pre-existing data from these devices for transmission testing, rather than prospectively generating new patient data for the purpose of the study. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
One expert was used to establish the ground truth for the visual comparison of printed ECG and textual data. This expert was identified as a cardiologist. Specific qualifications (e.g., years of experience) were not provided.
4. Adjudication Method for the Test Set:
For the digital comparisons, the adjudication method was software-based comparison to determine the integrity of the digital transfer. This implies an automated, objective comparison without human adjudication.
For the visual comparisons of printed data, the adjudication method was single expert review, where a cardiologist compared the pre- and post-transmission print-outs. No multi-reader adjudication method (like 2+1 or 3+1) was used.
5. 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 done. This study focuses on the data transfer and display capabilities of the CIS, not on the interpretative accuracy of an AI or human readers, or how AI might assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a form of standalone performance was implicitly done for the digital comparison aspects. Software was used to determine the integrity of the digital transfer, meaning the algorithm (CIS's data handling) was evaluated independently of human interpretation of the raw digital data. However, for the visual integrity of printed reports, a human (cardiologist) was in the loop.
7. The Type of Ground Truth Used:
Two types of ground truth were used:
- Original Digital Data: For the digital transmission integrity tests, the "pre-transmitted information" was considered the ground truth against which the received and stored information at the CIS was compared.
- Original Printed Reports and Expert Visual Comparison: For the visual integrity tests, the "pre-transmission print-outs" from the source devices served as the visual ground truth. The "cardiologist compared the pre- and post-transmissions for significant differences," indicating that expert visual assessment established the ground truth for acceptability.
8. The Sample Size for the Training Set:
The document does not mention a training set. This device is a data management system, not an AI/ML-driven diagnostic algorithm that typically requires a training set. The performance testing described relates to data transfer and display integrity.
9. How the Ground Truth for the Training Set was Established:
As no training set was mentioned or implied, this question is not applicable.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).