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The All-in-One Health Monitor PC-303 is a device designed for spot-checking measuring of the patient's physiological parameters, such as Non-Invasive Blood Pressure (NIBP), Oxygen saturation (SpO2), Pulse Rate (PR) and Body Temperature (TEMP);

Additionally, the device is available to communicate with the compatible Blood Glucose Monitoring System and ECG monitor to make the measurement.

This device is applicable for Adult and Pediatic (age>3 years old) use in clinical institutions and has no conditions or factors of contraindication.

The All-in-One Health Monitor, PC-303 is mobile modular designed patient monitor. It monitors the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic, diastolic and mean) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.

Additionally, the device is also capable to link and communicate with the compatible Blood Glucose Meter and ECG monitor to make the measurement.

This device system measure the patient's physical parameters with variety modules. It takes digital signals from NIBP, SpO2, Temperature module through COM ports, and receives ECG data, blood glucose data from compatible legally marketed ECG Monitor or BLOOD GLUCOSE MONITORING Device. The software to process the data, then display parameters on the screen and storage some useful information.

This device is applicable for use in clinical institutions and has no conditions or factors of contraindication.

The provided document describes the All-in-One Health Monitor, PC-303, and its substantial equivalence to a predicate device (UP-7000 Patient Monitor, K123711). The acceptance criteria are primarily based on meeting relevant international standards for medical electrical equipment and specific performance characteristics in comparison to the predicate device.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are not explicitly stated as distinct numerical targets in a single table within the document but are inferred from the comparison with the predicate device and the adherence to recognized international standards. The "reported device performance" is the claim of compliance with these standards and the equivalent performance to the predicate.

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

The document states that "Clinical testing was performed for the NIBP functions and are submitted as part of this submission." However, it does not specify the sample size used for this clinical testing or the data provenance (e.g., country of origin, retrospective/prospective).

For biocompatibility testing, the "In Vitro Cytotoxicity Test" used L929 mouse fibroblast cells, and the "Tests for irritation and skin sensitization" used guinea pigs. These are standard biological test methods, not human clinical sample sizes.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for any of the performance or clinical studies.

4. Adjudication method for the test set

The document does not describe any adjudication method used for the 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

This device is a patient monitor with built-in and external measurement capabilities for physiological parameters (SpO2, NIBP, TEMP, Blood Glucose, ECG). It is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance would not be applicable and was not reported.

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

The device is a medical instrument that provides physiological measurements. Its performance is inherent in its measurement capabilities and adherence to performance standards. The "standalone" performance is essentially its ability to accurately measure the parameters as specified, which is verified through testing against standards and comparison to a predicate device. The document mentions "Performance testing was performed to ensure that all of the device operated within specified parameters independently and with all other functions of the device operating." This indicates standalone performance testing of its direct measurement capabilities.

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

The ground truth for the measurements would typically be established by highly accurate reference instruments or established clinical methods, as dictated by the specific IEC/ISO/ASTM standards (e.g., for NIBP, a reference sphygmomanometer; for SpO2, a co-oximeter with induced hypoxia studies; for temperature, a reference thermometer). The document implies adherence to these standards for validation rather than explicitly stating ground truth derivation methods for each measurement. For NIBP, the reference to "clinical testing" would imply comparison to a clinically accepted gold standard.

8. The sample size for the training set

This device is a physiological monitor, not an AI/machine learning device that typically requires a "training set" in the context of algorithm development. Therefore, the concept of a training set sample size does not apply here.

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

As the device does not employ a machine learning algorithm requiring a "training set," this question is not applicable.

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