(266 days)
- Recording of two- or three-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 24-hour period.
- High-resolution recording of surface ECG data.
- Analysis of recorded Holter ECG data.
Syneflash™ is a light-weight digital ambulatory electrocardiogram (ECG) recorder (Holter monitor) equipped with a graphic LCD screen, and using a flash-memory card for data storage. It allows 24-hour ambulatory ECG recording and high-resolution recording, using 2 or 3 channels. Syneflash™ is supplied in a case containing a 10-, 20- or 40-MB flash-memory card, two 1.5-V AA batteries, a carrying case, a strap, a five-lead (or seven-lead) patient cable and a user's manual. Syneview™ is a Holter ECG analysis software application that allows evaluation of Holter recordings obtained with Syneflash™. Syneview™ is a Microsoft Windows95/98-based application run on an IBM-compatible personal computer equipped with a flash-card reader.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Group | Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|---|
| Syneflash™ Safety Testing | Environmental and safety tests, including EMC (Electromagnetic Compatibility) tests, according to the EN 60601-1, EN 60601-1-2 and ANSI/AAMI EC38-1994 standards. | The submission provides reasonable assurance that the Syneflash™ / Syneview™ Holter ECG system will perform in a safe and effective manner. (Implies compliance with these standards.) |
| Syneview™ Database Testing | Database testing according to the ANSI/AAMI EC38-1994 standard using the following databases: AHA (American Heart Association), MIT (Massachusetts Institute of Technology), ST (European database on ST segment), NST (Noise Stress Test). | The submission provides reasonable assurance that the Syneflash™ / Syneview™ Holter ECG system will perform in a safe and effective manner. (Implies satisfactory performance against these databases.) |
| Syneflash™ / Syneview™ Software Validation and Verification Testing | Unit and functional testing for both Syneflash™ and Syneview™ software applications. | The submission provides reasonable assurance that the Syneflash™ / Syneview™ Holter ECG system will perform in a safe and effective manner. (Implies successful completion of these tests.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions validation against the AHA (American Heart Association), MIT (Massachusetts Institute of Technology), ST (European database on ST segment), and NST (Noise Stress Test) databases. However, it does not specify the sample size (number of cases/recordings) used from each of these databases for the test set.
The provenance of these databases is given by their names:
- AHA (American Heart Association): Implies data from the United States.
- MIT (Massachusetts Institute of Technology): Implies data from the United States.
- ST (European database on ST segment): Implies data from Europe.
- NST (Noise Stress Test): This likely refers to a synthetic or specifically prepared dataset designed to test noise robustness, rather than a collection of clinical patient data.
The document does not explicitly state whether the data from these databases was retrospective or prospective, but publicly available, established databases like AHA and MIT are typically retrospective collections of previously recorded data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used or their qualifications for establishing the ground truth of the databases used (AHA, MIT, ST, NST). For established public databases, the ground truth is typically pre-annotated by experts or derived from established clinical criteria.
4. Adjudication Method for the Test Set:
The document does not specify the adjudication method used for establishing the ground truth in the test sets. For public databases, the annotations are usually a result of a consensus process among previous experts or follow specific guidelines.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in this submission. The testing described focuses on the standalone performance of the device against established databases, not on human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance evaluation was done. The "Syneview™ database testing" directly assessed the performance of the Syneview™ analysis software (the algorithm) against the AHA, MIT, ST, and NST databases. This is a measure of the algorithm's performance without a human in the loop during the analysis phase.
7. The Type of Ground Truth Used:
The ground truth used was based on expert consensus/established annotations from the reference databases:
- AHA (American Heart Association) database: Contains expert-annotated ECG recordings, often used for arrhythmia detection algorithm validation.
- MIT (Massachusetts Institute of Technology) database: Specifically, the MIT-BIH Arrhythmia Database, which is widely used and contains expert-verified annotations for various cardiac arrhythmias.
- ST (European database on ST segment): Likely contains expert-verified annotations related to ST-segment changes relevant to ischemic events.
- NST (Noise Stress Test): This database would have a predefined "ground truth" concerning the presence and characteristics of noise, against which the system's robustness is evaluated.
8. The Sample Size for the Training Set:
The document does not specify the sample size used for the training set. It only describes the testing performed on the device.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide information on how the ground truth for the training set was established. The focus of this submission is on the validation and verification of the device, not the details of its development or training data.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).