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The Spacelabs Lifescreen PRO Analyzer (Model 98800 Analyzer) is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible ECG recorders. Lifescreen PRO is capable of analyzing the ECG, detecting certain arrhythmias, allowing the user to view and edit analysis results, correlating symptomatic patient events and construct a report for use by Physicians / Cardiologists.

Lifescreen PRO can be used as a triage tool for assessment of ambulatory ECG from supported devices; supporting selection and export of ECG segments for more detailed analysis in the Spacelabs Pathfinder SL Analyzer.

The Spacelabs Lifescreen PRO Analyzer is a rapid analysis software product that can be used to analyze electrocardiology (ECG) recordings of up to 30 days in duration from Spacelabs Healthcare's range of Ambulatory ECG recorders. The ECG recordings are downloaded into the Sentinel Cardiology Information Management System (Sentinel), cleared by FDA in 510(k) submission K152881, imported into Lifescreen PRO, and then analyzed.

Lifescreen PRO is designed to provide a rapid analysis of the detection and reporting of major arrhythmic events and patient reported symptomatic events including AF, Pause, VT, V-Run (>3 beats), Trigeminy and Bigeminy, SVT, SV-Run, and Bradycardia.

Individual normal, ventricular, and supraventricular beat burdens are presented as a percentage of the total beat counts.

No automated algorithm for arrhythmia detection offers 100% sensitivity and accuracy for the detection of arrhythmia events. Laboratory testing and clinical studies have shown that scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy. Following analysis, the report should be reviewed by a physician prior to initiating or changing patient treatment.

ECG data with a lot of noise, which can result from poor hook-up and/or poor-quality electrodes, can result in beat misclassification. The algorithm monitors the ECG quality throughout and will inhibit analysis during periods of noise; the inhibited analysis is clearly shown in grey. This allows the user to review the inhibited areas to ensure that significant events have not been missed.

Various tools are provided in Lifescreen PRO to allow the trained user to quickly view the full disclosure ECG, add, delete, or reclassify events and beats, or artefact periods of noisy ECG. Where more detailed analysis is required, Lifescreen PRO also has the ability to export sections of a recording up to 7 days in duration into the Sentinel Cardiology Information Management System for further analysis using the Pathfinder SL analysis system.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics in the format requested. While it mentions that "Test results indicated that the Lifescreen PRO complies with internal requirements, applicable Standards, and the guidance document," it does not provide the quantitative acceptance criteria, the reported device performance against those criteria, or the methodology of such a study.

However, based on the general information provided about the device's capabilities and regulatory compliance, I can infer some aspects and construct a table to illustrate the type of information that would be present if it were fully detailed.

Here's a breakdown of what can be extracted and what is missing:

The Spacelabs Lifescreen PRO Analyzer is designed for:

• Analyzing ambulatory ECG recordings.
• Detecting certain arrhythmias (AF, Pause, VT, V-Run (>3 beats), Trigeminy, Bigeminy, SVT, SV-Run, and Bradycardia).
• Allowing user review and editing of analysis results.
• Correlating symptomatic patient events.
• Constructing a report for physicians/cardiologists.
• Serving as a triage tool for assessment and export of ECG segments for more detailed analysis.

The document indicates that the device undergoes "performance testing" in accordance with internal requirements and standards like IEC 60601-2-47: 2012 (Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems). This standard would typically define performance requirements for arrhythmia detection and accuracy.

Missing Information:

• Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets for each arrhythmia).
• Reported device performance (actual values) for these criteria.
• Details of the study that generated these performance numbers (sample size, data provenance, ground truth establishment, expert qualifications, adjudication method, standalone vs. MRMC).
• Training set details.

Inferred Table of Acceptance Criteria and Reported Device Performance (Illustrative - actual values not provided in the text):

Study Details (Based on what can be inferred or what is explicitly missing):

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text mentions "Laboratory testing and clinical studies," but no details on the datasets used.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified.
   • Qualifications: "scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy." It also mentions "reviewed by a physician prior to initiating or changing patient treatment." However, the exact qualifications of those establishing the ground truth for a test set are not detailed.

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

   • Not specified.

4. 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:

   • The text describes the device as providing "rapid analysis" and assisting "selection and export of ECG segments for more detailed analysis." It also states, "No automated algorithm for arrhythmia detection offers 100% sensitivity and accuracy for the detection of arrhythmia events. Laboratory testing and clinical studies have shown that scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy." This implies that the device is intended to be used with human review, but it doesn't explicitly describe an MRMC comparative effectiveness study or quantify improvement with AI assistance.

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

   • The document implies that standalone performance was evaluated, as it refers to the algorithm's detection capabilities. However, it strongly emphasizes the need for human review to achieve the "highest degree of report accuracy." It does not provide specific standalone performance metrics distinct from a human-in-the-loop context.

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

   • Implicitly, the ground truth for ECG analysis and arrhythmia detection would be established by expert consensus based on manual review of ECG recordings, likely by cardiologists or trained technicians. This is suggested by phrases like "scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy" and "reviewed by a physician."

7. The sample size for the training set:

   • Not specified.

8. How the ground truth for the training set was established:

   • Not specified, but likely similar to the test set, involving expert review and annotation of ECG recordings.

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