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The Sleuth AT system is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:

• Patients with clinical syndromes or situations at increased risk of cardiac . arrhythmias
• Patients who experience transient symptoms that may suggest a cardiac . arrhythmia

The Sleuth AT Implantable Cardiac System is an electrocardiogram (ECG) monitoring system that includes an implantable component and that provides continuous ECG monitoring and episodic or segmented ECG recording. The Sleuth AT Implantable Cardiac System comprises three interrelated components: Implantable Loop Recorder (ILR), Personnel Diagnostic Manager (PDM) and Base Station.
The Sleuth AT System incorporates modified brady, asystole, and tachy detection algorithms; additional trending capabilities; EMG detection/rejection; and program pending mode when compared to the original Sleuth System. There are no changes to the Indications for Use and only minor mechanical updates to the ILR and PDM.

Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance Study

The provided document describes the Sleuth AT Implantable Cardiac Monitoring System, a device designed to monitor and record ECGs for diagnosing cardiac arrhythmias. The primary study referenced is the PULSE study, initially conducted on the predicate device (Sleuth system, Model 2010), and its findings are applied to the new Sleuth AT system due to substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the PULSE study results "still support the new device Sleuth AT, due to the similarities between the two devices and verifications presented in the 510(k) Notification." The performance metrics reported for Sleuth AT are derived from applying its arrhythmia detector to standard databases and the collected clinical data from the predicate study.

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

• Sample Size for PULSE Study (Predicate Device): 28 patients.
• Data Provenance (PULSE Study): Four major medical centers in Panama. The study was prospective in nature for the original Sleuth system.
• Sample Size for Sleuth AT Evaluation:
  • MIT-BIH database: Not specified, but this is a widely recognized public ECG database.
  • Collected clinical data: This refers to the ECGs collected from the 28 patients in the PULSE study, which were then applied to the Sleuth AT detector.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts used or their qualifications for establishing the ground truth in the PULSE study or for the MIT-BIH database. It mentions that the study aimed to "evaluate the diagnostic viability of the ECG signals," implying expert review, but details are absent.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for establishing the ground truth in the PULSE study or for the MIT-BIH database.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or reported in the provided text. The evaluation focuses on the device's standalone performance rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done. The document explicitly states:
"Based on the similarity of the two devices, the new Sleuth AT's arrhythmia detector was verified using standard ECG databases, and ECGs collected in the above study of the predicate Sleuth system. The sensitivity and positive value of R-wave detection was 98.6% and 99.5% (MIT-BIH data base)... Furthermore, when the collected clinical data was applied to the Sleuth AT detector, the percentage of auto-triggered events that were false positives was found to be 95.96%, while the fraction of true positive autotriggers was 4.04%."
This indicates that the algorithm's performance was assessed independently of human interpretation in these tests.

7. Type of Ground Truth Used

• PULSE Study (Predicate Device): The ground truth for the "diagnostic viability of the ECG signals" and "true and false positive rates" for auto-triggers would likely have been established through expert consensus/clinical diagnosis based on the monitored ECGs. No explicit mention of pathology or outcomes data for ground truth.
• Sleuth AT Evaluation (using MIT-BIH & clinical data):
  • MIT-BIH database: This database is widely used and provides expert-annotated ground truth for ECG events.
  • "Collected clinical data": Ground truth for this data would be based on the clinical diagnoses derived from the original PULSE study, likely established by expert review.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set of the Sleuth AT's arrhythmia detection algorithms. It only refers to verification using standard databases and collected clinical data.

9. How Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for the training set was established. Given the nature of cardiac arrhythmia detection, it would typically involve expert cardiologists or electrophysiologists annotating ECG recordings. However, this information is not provided for the Sleuth AT.

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