(260 days)
- Assessment of symptoms that may be related to rhythm disturbances of the hear. Parients with . palpitations; The evaluation of arrhythmia's in parients from pediatric to adult age.
- Assessment of risk in pariems with or without symptoms of arrhythmia ♥
- Assessment of efficacy of Antiarrhythmic therapy. .
- Assessment of Pacemaker Function. .
- Assessment of real time ST segment analysis .
- Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and . arrhythmia analysis during exercise testing
- Assessment is for single-hospital environment ◆
A Zymed Telement monitoring system consists of a series of interface devices to include ECG transmitters, a central Telementy monitoring computerized until a surin chart recorder, Easi 5 (12 lead derived), and laser printer. The Zymed central monutor supports up to eight parients for real time curdial monitoring. The system displays each patient's ECG community on the screen while performing real time ECG wave form analysis for all eight patients. Thus analysis permits immediate detection and classification of abnormal beats, cardiac rhythm disturbances and variations.
Each ECG transmitter's frequency can be programmed to operate at any frequency within the entire VHF band For US domestic sites, the transmitters will comply with FCC band allocations (174-216 Mich. In addition to ECG data, the transmitters also detect and transmit cardiac pacemaker information. Other information including transminer status and individual lead impediated is the Zyned system for overall system safety and efficacy.
The Zymed system presents the user with a number of clinical tools such as visual and audible alarms and derived 12 lead display for the diagnosis of parients with various heart conditions. The system also provides tools to review a patient's cardiac performance. Con-line review mechanisms as well as detailed analysis screens have been designed into the system to facilitate and to enhance the patient's diagnosis and treatment. Features such as individual ECG printous, multi-channel automatic ST analysis, trend data analysis, and Full Disclosure data further enhance the system's qualities as a valuable and practical clinical
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Study (Zymed EasiView Telemetry System)
1. Table of Acceptance Criteria and Reported Device Performance
The document states, "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases. Results were typical for the real time monitoring environment for the EasiView as targeted." While specific numerical acceptance criteria (e.g., minimum sensitivity or specificity values) are not explicitly provided in the text, the study implies that the device met the generally understood "typical" performance for real-time monitoring against established cardiac databases. The document also states that performance data between the two Zymed systems (the new EasiView and the predicate) shows "nearly identical data."
Based on the provided text, the criteria are implicitly derived from the established performance on these benchmark databases.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| QRS detection performance (Sensitivity, Positive Predictivity, False Positive Rate) against AHA, MIT, and EST databases. | "Results were typical for the real time monitoring environment for the EasiView as targeted." |
| Separate SE, +P, and FPR were "examined for each database and measured for QRS." | |
| "Performance data between the two systems shows nearly identical data." | |
| Ventricular arrhythmia detection performance (Sensitivity, Positive Predictivity, False Positive Rate) against AHA, MIT, and EST databases. | "Results were typical for the real time monitoring environment for the EasiView as targeted." |
| Separate SE, +P, and FPR were "examined for each database and measured for... Ventricular." | |
| "Performance data between the two systems shows nearly identical data." | |
| Couplets detection performance (Sensitivity, Positive Predictivity, False Positive Rate) against AHA, MIT, and EST databases. | "Results were typical for the real time monitoring environment for the EasiView as targeted." |
| Separate SE, +P, and FPR were "examined for each database and measured for... Couplers." | |
| "Performance data between the two systems shows nearly identical data." | |
| Short runs detection performance (Sensitivity, Positive Predictivity, False Positive Rate) against AHA, MIT, and EST databases. | "Results were typical for the real time monitoring environment for the EasiView as targeted." |
| Separate SE, +P, and FPR were "examined for each database and measured for... Short runs." | |
| "Performance data between the two systems shows nearly identical data." | |
| Long runs detection performance (Sensitivity, Positive Predictivity, False Positive Rate) against AHA, MIT, and EST databases. | "Results were typical for the real time monitoring environment for the EasiView as targeted." |
| Separate SE, +P, and FPR were "examined for each database and measured for... Long runs." | |
| "Performance data between the two systems shows nearly identical data." | |
| High heart rate performance (including pediatric patients). | "High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm." |
| "Performance data between the two systems shows nearly identical data." | |
| Performance in the presence of noise (baseline, electrode, muscle). | "Performance in the presence of noise indicates the new system is equal to or better than the old system when looking at baseline, electrode or muscle as the cause of noise." |
| "Performance data between the two systems shows nearly identical data." | |
| ST Segment Analysis/Alarm (Implicitly, that its performance is acceptable for the new feature and maintains overall system performance at par with the predicate). | The only explicit discussion of this feature is that the "only difference between the two Zymed systems is the addition of automatic Multi-channel ST Analysis/alarm to the algorithm." The statement that overall "performance data between the two systems shows nearly identical data" implies that the ST Analysis feature did not negatively impact the device's overall performance to an unacceptable degree, and it's considered "substantially equivalent." |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The document only mentions using "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." The exact number of patients or ECGs from these databases used in the test set is not provided.
- Data provenance: The data came from "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." These are well-known, publicly available, and extensively used retrospective ECG databases from various institutions. The specific countries of origin for each database are not mentioned in this document, but they are generally international in scope (e.g., MIT/BIH Arrhythmia Database from the US, European ST-T Database primarily from Europe). The data is retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated. For established public databases like AHA, MIT, and EST, the ground truth is typically established through a consensus of multiple cardiologists or expert reviewers, but the specific number and qualifications are not mentioned in this document.
4. Adjudication method for the test set
Not explicitly stated. For established public databases, the adjudication method for ground truth is usually a consensus process (e.g., multiple experts reviewing and agreeing, often with a tie-breaker if needed), but this document does not detail it.
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, a multi-reader, multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not done. This device is a "Telemetry Central Station Monitor" performing "real time ECG wave form analysis" for "immediate detection and classification of abnormal beats, cardiac rhythm disturbances and variations." The study compared the device's performance against established databases and against its predicate device, not the performance of human readers using the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The document states, "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." This describes the algorithm's direct performance against annotated databases, without human intervention in the loop during the measurement of these specific metrics (SE, +P, FPR for various beat types and conditions). The comparison to the predicate device also focuses on the algorithmic performance.
7. The type of ground truth used
The ground truth used for the test sets (AHA, MIT, EST databases) would be expert consensus annotations. These databases are meticulously reviewed and labeled by cardiology experts to establish the "true" events (e.g., QRS complexes, ventricular beats, ST segment changes) against which algorithms are benchmarked.
8. The sample size for the training set
Not explicitly stated. The document refers to the evaluation being performed against the AHA, MIT, and EST databases, which are typically used for testing and benchmarking rather than for training a new algorithm. It's possible the new "automatic Multi-channel ST Analysis/alarm" algorithm was trained on proprietary data or a subset of these large databases, but the training set size is not provided.
9. How the ground truth for the training set was established
Not explicitly stated. Given that the training set size is not provided and the primary databases mentioned are benchmark testing databases, the ground truth establishment method for training data is unknown from this document. However, for medical algorithms, ground truth for training data would typically be established by expert review (e.g., cardiologists annotating ECG recordings).
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.