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The intended use of the Q-Tel® Telemetry System v. 6.0 (ST) is the acquisition and transmission of ECG data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting to a central monitor where it is received, displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change. The intended population are ambulatory adults where cardiac monitoring is prescribed while undergoing exercise rehabilitation.

The Q-Tel® Telemetry System v. 6.0 (ST) consists of a central receiver, transmitter, viewing monitor, keyboard, and accessories. ECG data is received via the transmitter to the central receiver and is displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change.

The provided text describes the Q-Tel® Telemetry System v. 6.0 (ST) and its performance testing. However, it does not explicitly state acceptance criteria in a quantitative table or the specific results to demonstrate direct adherence to such criteria. The document mentions that "Conclusion shows tape-by-tape results that indicate the algorithm's ability to detect events of clinical importance" but does not provide these detailed results or a comparison against predefined numeric thresholds.

Therefore, much of the requested information cannot be definitively extracted from the provided text.

Here's an attempt to answer based on the available information:

Acceptance Criteria and Study Details for Q-Tel® Telemetry System v. 6.0 (ST)

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of explicit, quantitative acceptance criteria with corresponding performance metrics. It generally states that the "Conclusion shows tape-by-tape results that indicate the algorithm's ability to detect events of clinical importance" for both arrhythmia detection and ST algorithm testing.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document refers to "tape-by-tape results," suggesting individual recordings were used, but the total number of tapes or patients is not provided.
• Data Provenance:
  • Arrhythmia Detection: Data was tested "in accordance with AAMI recommended practice, Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms." This typically implies standardized arrhythmia databases, which often consist of retrospective recordings. However, the exact source or country of origin is not specified.
  • ST Algorithm: Data was "using a test protocol from the European ST-T Database sponsored by the European Society of Cardiology." This indicates the data is from Europe and is likely retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the text. The document refers to testing against "AAMI recommended practice" and the "European ST-T Database," but it does not detail how the ground truth within these sources was established or the qualifications of the experts involved.

4. Adjudication method for the test set:

This information is not provided in the text.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not mentioned or described in the provided text. The testing described is focused on the standalone algorithm performance against established industry practices and databases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, a standalone algorithm performance study was done. The description focuses entirely on the "arrhythmia detection" and "ST algorithm" functions being tested against established protocols and databases, implying evaluation of the algorithm's performance independent of human-in-the-loop interaction.

7. The type of ground truth used:

• Arrhythmia Detection: The ground truth would have been established within the "AAMI recommended practice" ventricular arrhythmia detection algorithms. This typically involves expert-annotated ECG recordings of various arrhythmias.
• ST Algorithm: The ground truth would have been established within the "European ST-T Database." This database contains expert-annotated ECG recordings with ST segment changes.

8. The sample size for the training set:

The sample size for the training set is not provided in the text. The document focuses on performance testing of the device, not its development or training process.

9. How the ground truth for the training set was established:

This information is not provided in the text. The document does not describe the training phase of the algorithm.

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