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The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest non-lethal cardiac arrhythmia. The device continuously monitors and records the data, automatically records alarm events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician.

TeleSentry is a battery powered ambulatory ECG monitor which analyzes an electrocardiographic signal. The TeleSentry device classifies all detected heart beats and recognizes specific rhythm abnormalities. All detected results, including annotations for every detected heart beat and the ECG signals are securely transmitted via a cellular telephony network to a remote server. The server is accessible by a monitoring center for review and evaluation by trained qualified medical staff. The data transmission is automatically triggered when abnormalities are detected. The triggering criteria are based on physician's recommended predetermined settings and adjustable thresholds programmed for brady, tachy, pause and afib events. The data will also be transmitted when manually triggered by the patient; or periodically if programmed for regular transmission. The TeleSentry device is equipped with sufficient memory and processing capacity to record the signal received from the sensor, even while in parallel, allowing interrogation of the device data or adjustment of triggering thresholds. The TeleSentry device records and stores the entire ECG full disclosure for up to 30 days on its internal storage card. When cellular service is not available, the monitoring center is immediately notified and data can be transmitted via land-line telephone using a USB connection or a Bluetooth connection, or via broadband internet connection.

The provided text describes the ScottCare TeleSentry Wireless Ambulatory ECG Arrhythmia Monitor and its 510(k) submission (K092947). It references performance testing against established standards but does not detail a specific study with acceptance criteria and reported device performance in the format requested.

Here's a breakdown of the available information based on your request, highlighting what is not explicitly stated in the document:

1. A table of acceptance criteria and the reported device performance

The document states: "The TeleSentry device was tested and meets the requirements of following performance standards in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm."
It lists the following standards:

• IEC 60601-1:1999 "Medical Electrical Equipment Part 1: General . Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995"
• IEC 60601-1-2:2001/AI:2004 "Medical Electrical Equipment - Part 1-2: General Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests" Class B
• AAM1/ANSI EC38:2007 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
• AAMI / ANSI EC57:1998/(R)2003 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms

However, the document does NOT provide a table detailing specific quantitative acceptance criteria (e.g., sensitivity, specificity for arrhythmia detection) from these standards and the TeleSentry's reported performance against them. It only states that the device "meets the requirements."

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The device description mentions data review by "trained qualified medical staff" in a monitoring center, but this refers to the operational use of the device, not the ground truth establishment for a validation study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

This information is not provided in the document. The filing is for a standalone arrhythmia monitor with an algorithm that triggers events for review by medical staff, not a system designed to directly improve human reader performance in a comparative study format.

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

Yes, the device description implies a standalone algorithm performance as it "analyzes an electrocardiographic signal," "classifies all detected heart beats and recognizes specific rhythm abnormalities," and "automatically records alarm events triggered by an arrhythmia detection algorithm." The phrase "automatically records alarm events triggered by an arrhythmia detection algorithm" suggests standalone algorithmic detection. The subsequent review by medical staff is part of the clinical workflow, but the initial detection is algorithmic. The performance testing against AAMI / ANSI EC57:1998/(R)2003 (Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms) would involve evaluating the standalone algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not explicitly stated in the document. For cardiac rhythm algorithms, ground truth is typically established by expert cardiologists reviewing the ECG tracings and marking events. The standards referenced (especially AAMI EC57) define methods for establishing such ground truth, but the specific method used here for the TeleSentry's testing is not detailed.

8. The sample size for the training set

This information is not provided in the document. The document describes performance testing, not details about the development or training of the arrhythmia detection algorithm.

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

This information is not provided in the document, as details about the training set are absent.

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