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• 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 of transferred SpO2 level date from an MDE Escort Bedside monitor to EasiView for display and alarm.
• . Assessment of transferred Invasive and Non-Invasive blood pressure, both systolic and diastolic, data from an MDE Escort Bedside monitor to EasiView for display and alarm.
• Assessment of transferred temperature parameter data from an MDE Escort Bedside monitor to ● EasiView for display and alarm.
• Assessment of transferred respiration data from an MDE Escort Bedside monitor to Easi View for display.
• Assessment is for single-hospital environment.

A Zymed Telemetry monitoring system consists of a series of interface devices to include ECG transmitters, multi-parameter transmitters, a central Telemetry monitoring computerized unit with a strip chart recorder, Easi 5 lead 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. The system will also display each patient's Oxygen Saturation, Respiration, Non-Invasive Blood Pressure, Invasive Blood Pressure and Temperature.

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 Mhz). 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 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 Zymed system presents the user with a number of clinical tools such as visual and audible alarms for multi-parameter monitoring of the patient. The Zymed system provides a means to monitor multiple patients from a central monitoring station for ECG, Oxygen Saturation, Non-Invasive Blood Pressure, Invasive Blood Pressure, Temperature, and Respiration.

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 Laser Printer, print server options Strip Chart Networking

The provided text describes the Zymed Telemetry System: Model EasiView Telemetry Central Station Monitor and its performance evaluation for 510(k) clearance. Here's an analysis of the acceptance criteria and study as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative manner for all metrics. However, it implicitly uses the performance of industry-accepted databases and comparison to predicate devices as a benchmark for equivalence. The reported device performance is presented as being "typical" and "nearly identical data" to the comparator.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document does not explicitly state a specific "sample size" in terms of number of patients or recordings. It refers to the AHA (American Heart Association), MIT (Massachusetts Institute of Technology), and European ST-T (EST) databases. These are public databases of ECG recordings used for algorithm testing, implying a collection of pre-recorded data.
• Data Provenance:
  • Country of Origin: Not specified in the document, but the names (AHA, MIT, European ST-T) suggest origins in the US and Europe.
  • Retrospective or Prospective: The use of pre-existing, established databases (AHA, MIT, EST) indicates a retrospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not provide information on the number or qualifications of experts used to establish the ground truth within the AHA, MIT, and EST databases. The ground truth for these databases is typically established by expert cardiologists or technicians during the creation of the databases themselves, often through manual annotation and consensus. This information is inherent to the databases, not detailed in this specific submission.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the use of established databases, the ground truth labels within those databases would have been pre-adjudicated during their creation.

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 was not done. The study focuses on the standalone performance of the device's algorithms against established databases and a comparison of the device's technical characteristics and overall performance (e.g., noise handling, high heart rate) to a predicate device ("EasiView (Old) telemetry system" and "MDE Escort Monitor System (Old)"). There is no mention of human readers or AI assistance in the context of improving human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone (algorithm only) performance assessment was done. The performance evaluation was conducted against the AHA, MIT, and European ST-T databases, where the device's algorithms processed these pre-recorded ECGs and generated performance metrics (SE, +P, FPR, ESE, E+P, DSE, D+P) for arrhythmia and ST analysis.

7. The Type of Ground Truth Used

The ground truth used was based on expert consensus annotations within the established AHA, MIT, and European ST-T databases. These databases are recognized in the field for providing annotated ECG waveforms that serve as the "true" events against which algorithms are measured.

8. The Sample Size for the Training Set

The document does not specify the sample size for any training set. It only discusses the evaluation of the device's performance against the AHA, MIT, and EST databases, which are typically used for testing, not training, of algorithms after their development.

9. How the Ground Truth for the Training Set Was Established

Since the document does not mention the use of a distinct training set or its associated ground truth establishment, this information is not available in the provided text. The submission focuses on the evaluation of the already developed device.

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