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The Stealth System S300 is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, dizziness, anxiety, fatigue, syncope, light-headedness, shortness of breath or who are at risk of developing atrial fibrillation and where a software-assisted analysis of an ambulatory ECG could identify potential cardiac causes of these symptoms. It includes a prescription only, single use, continuous ECG recorder that can be worn up to 7 days during activities of daily living.

The Stealth System S300 consists of three components: (1) Sensor, (2) Smart Cable, and (3) StealthView personal computer software (PC Software). No component of the system is provided sterile. The Sensor is a 7-day, wearable, single use, disposable recorder that detects and records ECG signals and records patient event markers. Recorded data is retrieved by connecting the Sensor to StealthView software using the Smart Cable after the Sensor has been removed from the patient. StealthView software analyzes the recorded ECG signal and provides a report of heart rhythms for clinician review.

The provided text describes a 510(k) premarket notification for the Stealth System S300, a device designed for continuous ambulatory ECG recording and analysis to aid in the diagnosis of cardiac arrhythmias.

Here's a breakdown of the acceptance criteria and study information, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of "acceptance criteria" with specific numerical targets. Instead, it discusses the performance study by stating: "The Stealth System S300 ECG recorder and ECG analysis performance was quantified for the claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels that satisfy requirements and minimize safety or efficacy concerns."

However, it does provide a comparison table with the predicate device (ZIO SkyRunner (SR) Electrocardiogram (ECG) Monitoring Service) for various technological elements and detected rhythms. This implicitly defines the "performance" as being comparable to the predicate for all listed arrhythmias.

Note: The predicate device (ZIO ECG Utilization Service System) also detects "AV block," "Ventricular Trigeminy," "Ventricular Bigeminy," and "VF / TdP / PVT (CU)" which are not listed as detected by the Stealth System S300. The document states "None of the differences outlined in the tables above raise new questions of safety or effectiveness," implying that the lack of these detections for the Stealth System S300 does not preclude substantial equivalence for the specific indications claimed.

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

The document does not provide a specific sample size for a "test set" in the context of an arrhythmia detection study. It states that "Bench testing alone is sufficient and was completed in accordance with applicable FDA recognized consensus standards for ambulatory ECG recorder and analysis systems." This implies that the performance evaluation was based on bench-level testing rather than a clinical study with patient data.

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

The document does not mention the use of experts to establish ground truth for a test set. This is consistent with the statement that no animal or clinical studies were conducted, and that bench testing was deemed sufficient.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as a formal clinical study with human interpretation and adjudication was not performed according to the provided text.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "Animal and clinical studies were not conducted for the Stealth System S300 submission. Bench testing alone is sufficient..." Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The assessment described in the document primarily focuses on the standalone performance of the Stealth System S300's ECG analysis software (StealthView). The statement "The Stealth System S300 ECG recorder and ECG analysis performance was quantified for the claimed analysis metrics" refers to the algorithm's performance. The system provides an "analysis for review by the clinician to render a diagnosis," indicating an algorithm-only analysis that is then reviewed by a human.

7. Type of Ground Truth Used

The document indicates that the performance evaluation was based on "bench testing." This typically involves using simulated or validated ECG signals with known arrhythmias to test the algorithm's detection accuracy. It does not mention expert consensus, pathology, or outcomes data as ground truth for this performance study.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the StealthView algorithm.

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

The document does not describe how the ground truth for the training set was established.

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