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The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner.

The PROCARE Monitor B20 is not intended for use during MRI.

The PROCARE Monitor B20 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring.

Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.

The PROCARE Monitor B20 is a multi-parameter patient monitor. The PROCARE Monitor B20 has a10.4 inch LCD display with integrated keypad and a pre-configuration patient parameter measurement module (Hemo module), the PROCARE Monitor B20 also supports a thermal recorder and Airway gas module (E-MiniC, K052582) with an extension rack.

The PROCARE Monitor B20 includes features and subsystems that are optional or configurable. The PROCARE Monitor B20 interfaces to a variety of existing central station systems via a cabled network interface.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the PROCARE™ Monitor B20:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there are no specific, quantitative acceptance criteria or performance metrics explicitly stated for the PROCARE™ Monitor B20, as it is claiming substantial equivalence to a predicate device. The claim of performance is based on the assertion that its technical specifications remain the same as the predicate, with the exception of the screen size and backlight.

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

• Test Set Sample Size: Not applicable. The document states, "The subject of this premarket submission, The PROCARE Monitor B20 did not require clinical studies to support substantial equivalence." This means no dedicated test set from clinical trials was used to prove the performance of this specific device.
• Data Provenance: Not applicable. As no clinical studies were performed for this device, there is no clinical data provenance to report. The justification for equivalence is based on technical and design comparisons to the predicate device.

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

• Number of Experts: Not applicable. Since no clinical studies were performed, no experts were needed to establish ground truth for a test set for this device.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No clinical test set.

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:

• MRMC Study: No. This device is a multi-parameter patient monitor, not an AI-assisted diagnostic or interpretive system that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance.
• Effect Size: Not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance: Yes, implicitly. The device itself performs monitoring and analysis of physiological parameters (e.g., arrhythmia and ST segment analysis, SpO2, NIBP, heart rate). The claim of substantial equivalence implies that these internal algorithms perform adequately, as they are stated to be unchanged from the predicate device. However, no specific performance metrics for these algorithms are provided in this summary, nor are they evaluated in a standalone clinical study for this specific submission. The "standalone" here refers to the device's inherent functional performance as a monitor.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: Not applicable for this submission directly. The "ground truth" for the performance of the PROCARE Monitor B20 is established by its direct functional and technical equivalence to the predicate device, the PROCARE Monitor B40, which presumably had performance established through its own clearances. The submission relies on the assertion that "there are no changes to the parameter measuring hardware" and "all technical specification remains the same."

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device is a patient monitor, and the submission does not describe it as using machine learning or AI models that would require a "training set" in the conventional sense for its physiological parameter measurements. Its functionality is based on established signal processing and measurement algorithms.

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

• Ground Truth for Training Set: Not applicable. As no training set is described for this device, no method for establishing its ground truth is mentioned.

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