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V9 Patient Monitor is intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).

V9 Patient Monitor is used to monitor vital signals for patients and is intended to be used in controlled, hospital environments. It is applicable for adult, pediatric and neonatal patiented for helicopter transport, hospital ambulance or home use.

The V9 Patient Monitor can provide the monitoring of physiological parameters such as the Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp). The V9 Patient Monitor is a portable device, consists of main unit and accessories, including NIBP cuff, Temperature sensor, CO2 sensor and SpO2 sensor.

It consists of main unit and accessories, including NIBP cuff, Temperature sensor, CO2 sensor and SpO2 sensor.

All modules, boards and accessories used in V9 Patient Monitor has already been cleared by FDA, referring to Table 1. In which, two NIBP and three SpO2 modules are optional for proposed device.

The provided text is a 510(k) summary for the Shenzhen Biolight Meditech Co., Ltd. V9 Patient Monitor. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the proposed device to a predicate and confirming compliance with relevant standards, rather than detailing the full scope of acceptance criteria and a specific study proving those criteria are met for this new device in the way a clinical trial report would.

However, I can extract the information that is present and highlight what is not present given the nature of a 510(k) summary.

Here's an analysis based on your request:

Acceptance Criteria and Study Details for Guangdong Biolight Meditech Co., Ltd. V9 Patient Monitor

The V9 Patient Monitor is intended for monitoring, displaying, storing, and alarming for multiple physiological parameters: Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2), and Temperature (Temp).

The primary method for demonstrating acceptance criteria is by showing Substantial Equivalence (SE) to a predicate device (V6 Vital Signs Monitor, K153135) and compliance with recognized national and international standards for medical electrical equipment. No new clinical studies were conducted for this submission (as stated in point 6). Instead, the manufacturer relies on the previous clearance of its individual modules and compliance with established performance standards for each physiological parameter.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) demonstrating substantial equivalence based on previously cleared modules and compliance with standards, specific performance metrics for the new combined device (V9 Patient Monitor) are not presented in a direct "acceptance criteria vs. performance" table in the way one might see for a novel device undergoing clinical trials. Instead, the "acceptance criteria" are compliance with specific IEC/ISO standards, and the "reported device performance" is the assurance that the device meets these standards.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k). No new clinical data or human subject test sets were used. The "tests" referred to are non-clinical (engineering and performance assessment against standards) and rely on the prior clearances of the individual modules.
• Data Provenance: Not applicable for the reasons above.

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

• Number of Experts: Not applicable. No "ground truth" established by experts for a test set for this new device. The compliance with standards is assessed through engineering tests.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication was performed for this submission.

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, not an AI-assisted diagnostic tool involving "human readers" or image interpretation. Therefore, no MRMC comparative effectiveness study was done, and the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• This device is a patient monitor, which relies on sensors and processing algorithms to measure and display physiological parameters. While it contains algorithms, the submission doesn't detail their standalone performance in terms of "algorithm only" studies as would be seen for a complex AI diagnostic system. The performance is assessed by the device's ability to accurately measure and display parameters according to established medical device standards. The "standalone" performance is integrated into the compliance testing against the IEC/ISO standards mentioned above.

7. The type of ground truth used

• The "ground truth" in this context is defined by the established performance requirements and test methodologies outlined in the referenced IEC and ISO standards (e.g., accuracy requirements for NIBP, SpO2, CO2, Temp as defined in their respective standards). Compliance ensures the device's measurements are consistent with these industry-accepted benchmarks. For the previously cleared modules, their "ground truth" would have been established during their initial clearance process, likely through comparison to highly accurate reference methods or clinical data as appropriate for each module.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document does not describe the development of a novel algorithm requiring a training set in the AI sense. The device integrates previously cleared modules.

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

• Ground Truth for Training Set: Not applicable for the reasons mentioned above.

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