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The Vital Signs Monitor is indicated for use for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and CO2.

The Vital Signs Monitor is intended to be used only under regular supervision of clinical personnel. It is adaptable to adult, pediatric, and neonatal usage in a hospital, hospital type facilities environment and intra-hospital moves.

The Vital Signs Monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

M3B Vital Signs Monitor supplies the following features:

• 5.7 inch LCD display .
• Sp02, Pulse Rate, and Respironics CO2 measurement .
• Nellcor OxiMax SpO2 .
• Display numeric and waveform information simultaneously .
• Nurse call .
• Powerful storage capacity .
• Built-in Lithium-ion Battery ●
• Suitable for adult, pediatric and neonate patients .
• Visual and audible alarm .

The provided document describes the Edan Instruments, Inc. Vital Signs Monitor (Model M3B). This device is indicated for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and CO2.

However, the provided text does not contain the detailed acceptance criteria for the device's performance, nor does it present the specific study data that demonstrates the device meets such criteria. The document primarily focuses on the 510(k) summary, establishing substantial equivalence to predicate devices, and outlining the intended use and general testing performed.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states "Verification and validation testing was done on the M3B Vital Signs Monitor," but it does not specify what the acceptance criteria for SpO2 or CO2 accuracy were, nor does it report the device's measured performance against those criteria (e.g., accuracy, bias, precision for SpO2 or CO2 measurements).

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

Not available in the provided document. The document mentions "Software testing," "Safety testing," "Risk analysis," and "Final validation" as applied measures, but it does not discuss specific test sets for performance evaluation, their sample sizes, or data provenance (e.g., country of origin, retrospective/prospective).

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

Not available in the provided document. The document does not describe any studies involving expert review for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable/Not available in the provided document. As no specific test set involving expert review is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this document. This type of study typically involves human readers interpreting cases with and without AI assistance to measure performance improvement, which is not relevant for a vital signs monitor that provides direct measurements.

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

Yes, implicitly. Vital signs monitors like the Model M3B are standalone devices that provide objective measurements (SpO2, CO2, Pulse Rate). Their performance is inherently "standalone" in that they produce a numerical output based on sensor data without direct human interpretation being part of the measurement process itself. While the device's use requires clinical personnel supervision, the measurement of SpO2 and CO2 is an algorithm-only function. However, the results of such standalone performance (e.g., accuracy, precision) are not provided.

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

Not available in the provided document. For SpO2 and CO2 monitors, ground truth is typically established using highly accurate reference methods (e.g., co-oximetry for SpO2, calibrated gas analyzers for CO2) under controlled physiological conditions. However, the document does not specify how ground truth was established for the validation of this device.

8. The Sample Size for the Training Set

Not applicable/Not available in the provided document. The Model M3B is a vital signs monitor that measures physiological parameters. It is highly unlikely to involve a "training set" in the context of machine learning. Its algorithms are typically based on established physiological models and signal processing, not on training data in the AI sense.

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

Not applicable/Not available in the provided document. See point 8.

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