(92 days)
- Assessment of symptoms that may be related to rhythm disturbances of the heart: Patients with . palpitations; The evaluation of arrhythmia's in patients from pediatric to adult age.
- Assessment of risk in patients 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.
- Assessment of EASI derived 12-lead ST measurements is recommended for patients that meet the . following parameters.
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- Ages: 33 to 82 years
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- Heights: 147 to 185 cm (58 to 73 in)
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- Weights: 53 to 118 kg (117 to 2611b)
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- Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/b.)
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A Zymed Telemetry monitoring system consists of a series of interface devices to include ECG transmitters, a central Telemetry monitoring computerized unit with a strip chart recorder, Easi 5 (12 lead derived), and laser printer. The Zymed central monitor supports up to eight patients for real time cardiac monitoring. The system displays each patient's ECG continuously on the screen while performing real time ECG waveform analysis for all eight patients. This 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 Mbz). In addition to ECG data, the transmitters also detect and transmit cardiac pacemaker information. Other information including transmitter status and individual lead impedance is also transmitted to the Zymed 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 patients with various heart conditions. The system also provides tools to review a patient's cardiac performance. On-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 printouts, multi-channel automatic ST analysis, trend data analysis, and Full Disclosure data further enhance the system's qualities as a valuable and practical clinical tool.
The system has the following options available:
Choice of 4, 6, or 8 bed central monitor
Full disclosure screen and printout (full resolution programmable from 0 to 168 hours)
Choice of 6 lead sets, based on transmitter capability
Full arrhythmia analysis to include multi-channel automatic ST Analysis
12 lead ECGD
Laser Printer, print server options
Strip Chart
Networking
Here's an analysis of the provided text regarding the Zymed Telemetry System, Model EasiView:
Device: Zymed Telemetry System: Model EasiView Telemetry Central Station Monitor
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail manner. Instead, it states that "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." It then lists the types of metrics examined.
Given this, the table below will present the types of performance metrics used and a general summary of the findings as described in the submission.
| Metric Category | Specific Metrics Examined | Reported Performance |
|---|---|---|
| Arrhythmia Analysis (QRS, Ventricular, Couplets, Short runs, Long runs) | Sensitivity (SE), Positive Predictivity (+P), False Positive Rate (FPR) | "Results were typical for the real time monitoring environment for the EasiView as targeted." |
| ST Analysis (European ST-T database) | Episode Sensitivities (ESE), Episode Positive Predictivity (E+P), Duration Sensitivity (DSE), Duration Positive Predictivity (D+P) | "Results were typical for the real time monitoring environment for the EasiView as targeted." |
| High Heart Rates (incl. pediatric) | Performance at high heart rates | "Demonstrated to be within recommended guidelines in excess of 300 bpm." |
| Noise Presence | Performance in the presence of baseline, electrode, or muscle noise | "Indicates the new system is equal to or better than the old system." |
| Overall Comparison to Predicate | N/A (implicit comparison across all performance aspects) | "Performance data between the two systems shows nearly identical data, and therefore, supports a claim of Substantial Equivalence." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document refers to "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." However, it does not explicitly state the specific number of cases or recordings from these databases used for testing this particular device.
- Data Provenance: The document implies the use of pre-existing, standardized databases (AHA, MIT, EST). It does not specify the country of origin of the data within these databases or whether the data was retrospective or prospective. Given they are "industry accepted databases," it's highly likely they contain a mix of retrospective data collected over time from various sources.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide any information about the number or qualifications of experts used to establish the ground truth for the test sets (AHA, MIT, EST databases). For standardized databases like these, the ground truth is typically established by multiple expert cardiologists or arrhythmia technicians through a consensus process, but this submission does not detail that process for these specific databases.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the ground truth of the test set. For pre-existing, standardized databases, the adjudication would have been part of the database creation process, but it's not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses solely on the device's algorithmic performance against established databases and a comparison of its features and performance to a predicate device, not on human reader improvement with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone performance study was done. The entire section describing "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases" focuses on the algorithm's performance in detecting QRS, Ventricular events, Couplets, Short/Long runs, and ST analysis, without human intervention in the interpretation process.
7. The Type of Ground Truth Used:
The type of ground truth used was based on the annotations provided within the industry-accepted AHA, MIT, and European ST-T databases. These databases typically contain expert-adjudicated annotations for cardiac events (e.g., QRS complexes, arrhythmias) and ST segment changes, effectively representing expert consensus.
8. The Sample Size for the Training Set:
The document does not specify the sample size for the training set. It only discusses the performance evaluation against established test databases.
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 (if any distinct training was performed using Zymed's own data) was established. It only refers to using "industry accepted databases" for performance testing. If the device was trained using these same databases, the ground truth would be from those databases, which is typically expert consensus.
§ 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.