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The IntriCon Sirona is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. When event data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician.
The IntriCon Datrix Sirona is a combination Event Recorder and Holter Recorder that is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. In the Event Recorder mode, once event data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician. In the Holter Recorder mode, the device is intended for the recording of ECG data collected from ambulatory patients. The data is then reviewed by the physician after downloading and processing by a Holter playback system.

The IntriCon Sirona is a device for use as either an Event Recorder (ER), with or without Arrhythmia Detection, or Holter Monitor (HM). The device can operate in one of three modes depending on clinician selected options.

The provided text is a 510(k) summary for the IntriCon Datrix Sirona Event/Holter Recorder. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain information regarding detailed acceptance criteria or a specific study proving the device meets those criteria, particularly for performance metrics like sensitivity, specificity, or accuracy for arrhythmia detection.

The "Non-Clinical And Performance Testing" section broadly states: "Testing for the performance, functionality, and reliability characteristics of the device followed established test procedures in a quality system." It references compliance with several electrical safety and performance standards (IEC60601-1:1998, 2nd edition, IEC 60601-1-2: 2001, AAMI EC 38-1998) but does not provide specific performance data or a statistical analysis of diagnostic accuracy.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details because this information is not present in the provided document.

The document indicates that the device is an "Electrocardiograph, ambulatory (without analysis)" and states that "IntriCon Sirona is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. When event data is recorded, patients transmit the recorded ECG data... for review by a licensed physician." This strongly suggests that the device's primary function is data acquisition and transmission, with the diagnostic analysis being performed by a human physician, not the device itself. The phrase "without analysis" in the classification name further supports this.

Based on the provided text, the following information is either not applicable or not available:

1. Table of acceptance criteria and reported device performance: Not available. The document primarily focuses on electrical safety and functional standards, not diagnostic performance metrics.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not available, as diagnostic analysis is stated to be performed by a "licensed physician" reviewing the transmitted data.
4. Adjudication method for the test set: Not available.
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: Not applicable. The device is classified as "without analysis" and there's no mention of AI assistance. The physician performs the analysis.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's classification "without analysis" and intended use imply it does not perform standalone algorithmic analysis for diagnosis.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not applicable. There's no mention of an algorithm requiring training.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is available:

• Intended Use: Diagnostic evaluation of patients experiencing transient symptoms suggesting cardiac arrhythmia.
• Device Function: Records ECG data, which is then transmitted for review by a licensed physician. It can operate as an Event Recorder (with or without Arrhythmia Detection functionality, though the classification name says "without analysis") or Holter Monitor.
• Compliance: Tested to IEC60601-1:1998, 2nd edition, IEC 60601-1-2: 2001, AAMI EC 38-1998. These are generally electrical safety and basic functional standards for medical devices, not diagnostic performance standards for arrhythmia detection algorithms.
• Predicate Device Comparison: Claims "nearly identical technical data, same indications for use, same safety standards tested to" as Braemar Er900 (K071011/K072008) and Datrix VX3 (K031074). This is the basis for substantial equivalence, implying that if the predicates met certain performance, this device is expected to as well, but the specific performance data is not provided.

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