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The RVS-100 vital signs monitor is intended to be used for monitoring, reviewing, storing and sending alarms regarding multiple physiological patient parameters, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Noninvasive Blood Pressure (NIBP), and Temperature (Temp).

The RVS-100 vital signs monitor is intended to be used in controlled, hospital environments. It is not intended for helicopter transport, hospital ambulance or home use.

The Riester RVS-100 vital signs monitor can perform automatic blood pressure, pulse oximetry and body temperature measurements for clinical professionals. The RVS-100 is a portable device, consist of main unit and accessories, including NIBP cuff, Temperature sensor, and SpO2 sensor.

RVS-100 vital signs monitor has a DC power connector, RVS-100 can connect with extension device RVS-200 and supply power for RVS-200 through the DC power connector.

The provided text is a 510(k) summary for the RVS-100 Vital Signs Monitor. This document focuses on demonstrating substantial equivalence to a predicate device and includes information about non-clinical testing against recognized standards. It does not detail a clinical study with specific acceptance criteria, reported device performance metrics like sensitivity/specificity, or parameters related to AI/algorithm performance.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

• Cannot be directly created. The document lists non-clinical standards the device complies with (e.g., IEC 60601-1, IEC 80601-2-30). These standards have their own acceptance criteria, but they are general safety and performance standards for vital signs monitors, not specific performance metrics (like sensitivity, specificity, or agreement with a gold standard) for a diagnostic algorithm. The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." However, specific quantitative performance data against acceptance criteria are not provided in this summary.

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

• Not applicable / Not provided. No clinical test set data is described. The non-clinical tests would involve testing against equipment and simulated conditions, not a "sample size" of patients or data in the typical sense of a diagnostic study.

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

• Not applicable / Not provided. No clinical test set or ground truth establishment by experts is described.

4. Adjudication method for the test set

• Not applicable / Not provided. No clinical test set or adjudication method is described.

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

• No. This device is a vital signs monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

• N/A. The device itself performs measurements; it's not an "algorithm only" device in the context of diagnostic AI. Its performance is evaluated against physical measurement standards.

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

• Not applicable (for a clinical context). For non-clinical tests, the "ground truth" would be established by reference measurement devices or calibrated standards as per the specific IEC/ISO standards mentioned (e.g., a calibrated pressure meter for NIBP, a reference oximeter for SpO2). The document explicitly states: "Non-clinical testing is included in this submission, because all modules have been previously cleared by FDA." This implies reliance on established methods for vital signs measurement.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device that requires a training set in the typical sense.

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

• Not applicable / Not provided. As above, no training set for an AI/ML model is described.

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