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The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen santuation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (FiO2), Carbon dioxide Concentration (C02) and EtCO2 respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoofburane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System K020046 cleared for distribution on July 23, 2002. The device also monitors Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors and CCO/SvO2 Monitors .The device may generate an audible and/or visual alsommore a measured rate falls outside preset limits.

Bedside Monitor, Patient Monitor, Cardiac Monitor, Vital Signs Monitor and Anesthesia Monitor.

The provided text does NOT contain information about acceptance criteria or specific studies proving the device meets acceptance criteria in the format requested.

The document is a 510(k) notification for a bedside monitor, primarily focusing on demonstrating substantial equivalence to a predicate device. It briefly mentions general performance testing and software validation.

Here's what can be extracted, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not available. The document states that "performance testing procedures" and "software validation" were performed and the "results confirmed that the device performed within specifications," but it does not detail these specifications (acceptance criteria) or the specific performance metrics achieved.

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

• Not available. The document does not provide details on sample sizes for any test sets or the origin/nature of data used for testing (e.g., retrospective or prospective, country of origin).

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

• Not available. There is no mention of expert-established ground truth or the involvement of experts in any testing described.

4. Adjudication method for the test set:

• Not available. No adjudication method is mentioned.

5. 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:

• Not applicable/Not available. This device is a physiological patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers. Therefore, an MRMC study and effect size for human reader improvement are not relevant or discussed.

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

• Given that this is a bedside monitor with arrhythmia detection, it implies an algorithm operating in standalone mode. However, the document does not provide specific details or a dedicated "standalone study" report. It mentions "software validation tested the operation of the software function of the device," which indirectly supports standalone algorithm testing, but lacks specifics.

7. The type of ground truth used:

• Not available. The document does not specify the type of ground truth used for any testing. For a device like this, ground truth would typically be established against known physiological signals or reference equipment, but this is not detailed.

8. The sample size for the training set:

• Not available. The document does not mention any training sets, which is typical for a 510(k) for a device like this where the technology is largely established and the changes are minor, not involving new machine learning algorithm development from scratch.

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

• Not applicable/Not available. As above, no training set is mentioned.

Summary of available information related to performance testing:

The document broadly states:

• "The BSM-9100A Series Bedside Monitor device was subjected to tests for electromagnetic, environmental, safety and performance testing procedures."
• "These tests verified the operation of the device."
• "The software validation tested the operation of the software function of the device."
• "The results confirmed that the device performed within specifications."

However, these are very general statements and do not provide the detailed information requested regarding specific acceptance criteria, performance metrics, sample sizes, ground truth establishment, or expert involvement. This is common for 510(k) submissions focusing on substantial equivalence with minor changes, where detailed performance data might be referenced internally within the manufacturer's quality system but not explicitly detailed in the public 510(k) summary.

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