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Patient monitors are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Cerebral State Index (CSI), Bispectral Index (BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO), and Methemoglobin(SpMet).

The arrhythmia detection, ST segment analysis only applied to a single adult patient.

The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician.

It is not intended for helicopter transport, hospital ambulance, or home use.

The Patient Monitors consist of two parts, which are host units and function modules.

The host units of Any View A Series Patient Monitors are available in four modules, which are Any View A3, AnyView A5, Any View A6 and AnyView A8, The units, themselves, did NOT collect any physiological data from the patient, which are collected by function modules and transmitted to the host unit. They shall be worked with the basic function module, EMS or MPS.

The host units of Q Series Patient Monitors are available in six modules, which are Q2, Q3, Q6 and Q7. These host units could complete the measurement of ECG, RESP, TEMP, SpO2, NIBP and IBP.

In addition, there are several extended function modules, which could be connected with the host units to complete the measurement functions, including TEMP, CO2 Mainstream, CO2 Sidestream, SpO2 Nellcor, SpO2 Masimo, AG Mainstream, AG Sidestream, ICG and CSM (CSI).

Here's a breakdown of the acceptance criteria and the study information based on the provided document.

Acceptance Criteria and Device Performance

This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing specific performance metrics against pre-defined numerical clinical acceptance criteria. The acceptance criteria are primarily based on compliance with recognized medical device standards and qualitative comparison to a predicate device.

"Study" Information (Non-Clinical Test Conclusion)

The document primarily describes non-clinical tests to verify compliance with design specifications and demonstrate substantial equivalence, rather than a clinical study with a test set of patient data and expert ground truth.

1. Sample size used for the test set and the data provenance: Not applicable in the context of a clinical study. The document refers to "non clinical tests" and compliance with standards. It does not mention a test set of patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set of patient data is not mentioned as the study is non-clinical.
3. Adjudication method for the test set: Not applicable. There is no mention of a test set requiring adjudication.
4. 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. This device is a patient monitor, not an AI-assisted diagnostic tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the traditional sense of an AI algorithm. The performance evaluation is based on the device's ability to accurately measure physiological parameters and comply with industry standards, which inherently means its "standalone" performance for collecting and displaying data.
6. The type of ground truth used:
   • For safety and EMC: Compliance with international and national standards (IEC 60601-1, IEC 60601-1-2).
   • For performance of specific physiological measurements: Compliance with specific standards like AAMI EC13 (cardiac monitors), AAMI SP10 (sphygmomanometers), and ISO 9919 (pulse oximeters). These standards typically define accuracy requirements against known calibration sources or reference methods.
7. The sample size for the training set: Not applicable. This document does not describe a machine learning model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Overall Conclusion from the Document:

The proposed device (A Series / Q Series Patient Monitors) was determined to be Substantially Equivalent (SE) to the predicate devices based on non-clinical tests demonstrating compliance with recognized safety and performance standards. The comparison focused on intended use, technological characteristics, and principles of operation.

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