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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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The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to 168 hours (7 days) during activities of daily living. It 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, presyncope, light-headedness, shortness of breath and where a software-assisted analysis of the potential causes of these symptoms is desirable.

The Stealth™ Monitor is a small, lightweight, patch-style, single-use cardiac monitor designed for ambulatory collection of electrocardiographic (ECG) data continuously for up to 168 hours (7 days) and ECG signal characterization. It is worn on the patient's chest similar to an adhesive bandage. The housing is constructed of a foam material making the device very lightweight (less than 9 grams). A software application is installed at a physician's office to receive the data from the monitor using a direct connection. Data retrieved from the monitor may be printed or saved and stored for later viewing. The DSD software has the ability to generate reports as well as the ability to save a full disclosure ECG file for viewing.

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and studies:

Device Name: Stealth™ Monitor (S200, K142468)

Device Type: Prescription only single-use, continuous recording ECG monitor

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" for the device's performance in terms of diagnostic accuracy or specific metrics (e.g., sensitivity, specificity for detected arrhythmias). Instead, it focuses on the performance of the device's components and system in meeting regulatory standards and functional requirements.

The "Summary of Performance Testing" section lists various documentation provided, indicating that general safety and functional performance were evaluated. However, specific numerical acceptance criteria for arrhythmia detection or other clinical performance metrics are absent from this summary.

Therefore, based solely on the provided text, a table of acceptance criteria and reported device performance related to clinical accuracy cannot be constructed. The document primarily addresses the substantial equivalence to predicate devices based on indications for use and technological characteristics, along with adherence to software and safety standards.

Further analysis of the document indicates: No clinical studies demonstrating diagnostic performance (e.g., sensitivity, specificity for specific arrhythmias) with specific acceptance criteria are presented or referenced in this 510(k) summary. The "Stealth™ System S200" is listed with "Arrhythmias and/or statistics" of "Normal, fastest heart rate, slowest heart rate, average heart rate, pauses, bradycardia (run), tachycardia (run)," but there are no performance metrics provided for these detections. This 510(k) seems to rely on substantial equivalence to predicate devices for its claims, rather than new clinical performance data for arrhythmia detection.

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The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to least 24 hours. It is indicated for use with patients where it would be desirable to record ECG signals for this period of time.

Stealth™ Monitor, Docking Cable and Display and Storage Device

The provided text is a 510(k) premarket notification letter from the FDA to Cardiac Insight Inc. for their Stealth™ Monitor. This document, while indicating the device's regulatory approval, does not contain the detailed information required to answer the request about acceptance criteria, study findings, and ground truth establishment for a device study.

Specifically, the document focuses on regulatory approval and equivalence to predicate devices, rather than providing a performance study report.

Therefore, I cannot extract the requested information from the provided text.

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