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This device is capable of monitoring:

• heart rate
• respiration rate
• invasive pressure
• non-invasive pressure
• arrhythmia
• temperature
• cardiac output
• arterial oxygen saturation
• pulse rate
• cardiac output
• end-tidal carbon dioxide and (central) apnea.

This device can be connected to third party devices. Siemens SV300™ ventilator and the Baxter Vigilance™ blood gas/continuous cardiac ourput monitor. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will devermine when use of the device is indicated, based upon their professional assessment of the patient's medical condition. The device is intended to be used on Adult, Pediatric and Noonatal populations, with the exception of the parameter Cardiac Output which is intended for use in the adult and pediaric populations only; and Arrhythmia which is intended for use in the adult population only.

The Siemens SC9000/ SC9015 Bedside Monitoring System with modified Arrhythmia Monitoring is an updated software version of the Siemens SC900/ SC9015 Bedside Monitoring System. The modification improves the detection and monitoring of arrhythmia. The hardware of the SC9000/SC9015 is unchanged.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the arrhythmia monitoring functionality:

Acceptance Criteria and Reported Device Performance

The device's performance is compared against the predicate device through software modifications designed to improve arrhythmia detection. The key performance metrics are related to the accuracy and range of the ECG and QRS detection.

Note: The primary "acceptance criteria" here are implied by the claim that the "Clinical performance is equal to, or surpasses that of the predicate device" and compliance with specific AAMI and FDA guidelines. The table highlights where the modified device directly matches or improves upon the predicate.

Study Details

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

   • The document states that the "assessment of clinical performance is attached in appendix V," but Appendix V is not provided. Therefore, the specific sample size, country of origin, and whether the data was retrospective or prospective for the clinical performance assessment cannot be determined from the provided text.
   • However, the device's design and testing comply with AAMI (ECAR - D-94) "Draft: Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms' March 1994," and FDA "Guidelines for Submitting Data in Support of Pre-market Notification (510(K)) Applications for Arrhythmia Detectors (1990)." These guidelines typically specify protocols for test data and datasets.

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

   • This information is not explicitly stated in the provided text. The document refers to "assessment of clinical performance" but does not detail how ground truth was established or the number/qualifications of experts involved.

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

   • This information is not explicitly stated in the provided text.

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:

   • No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned. The device described appears to be a standalone monitoring system, not primarily an AI-assisted diagnostic tool for human readers in the context of image interpretation or similar. The "AI" would be the arrhythmia detection algorithm itself, which is integrated into the monitoring system.

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

   • Yes, a standalone assessment of the algorithm's performance was done. The entire submission focuses on the "modified arrhythmia algorithm" in the Siemens SC9000/SC9015 Bedside Monitoring System. The device directly processes physiological signals (ECG) to detect and monitor arrhythmia. The compliance with AAMI (ECAR - D-94) guidelines specifically for "Ventricular Arrhythmia Detection Algorithms" indicates a standalone algorithmic evaluation.

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

   • While not explicitly stated for the clinical assessment, for arrhythmia detection algorithms complying with standards like AAMI, ground truth is typically established through expert annotation of ECG waveforms. This involves cardiologists or trained technicians meticulously marking arrhythmia events on reference ECG databases.

7. The sample size for the training set:

   • This information is not explicitly stated in the provided text. The document describes an "updated software version" and "modified arrhythmia algorithm," implying a development and potentially a training phase, but details of the training set are absent.

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

   • This information is not explicitly stated in the provided text. Similar to the test set, it would typically involve expert annotation of ECG waveforms, but the specifics are not provided.

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