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The Accutorr 7/VS-900 Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2), on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.

The Accutorr 7/VS-900 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. This patient monitor consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.

This document is a 510(k) Summary for the SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Accutorr 7/VS-900 Vital Signs Monitor. It outlines the device's indications for use, description, performance data, and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and studies:

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

The document does not explicitly present a table of acceptance criteria. Instead, it details various performance specifications for each physiological parameter (Temperature, SpO2, Pulse Rate, NIBP) found in the "Predicate Device (K132038)" column, and states that the "Subject Devices" (Accutorr 7/VS-900) generally have the "Same" performance characteristics. For CO2 monitoring, it references the characteristics of the reference predicate (K152902).

Here's a compilation of the performance specifications, which act as the de facto acceptance criteria based on established predicate device performance:

The document states: "The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The 510(k) summary does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It broadly mentions "functional and system level testing" and "wireless functionality testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the 510(k) summary. The document focuses on performance testing against technical specifications and predicate device equivalence, rather than studies involving expert ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the 510(k) summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a vital signs monitor, not an AI-assisted diagnostic tool that would typically involve human readers or AI assistance in interpretation. The mention of "Modified Early Warning Score (MEWS)" is a calculated score based on vital signs, not an AI algorithm requiring human interpretation.

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

This concept is not directly applicable in the typical sense of AI algorithms for image analysis or diagnosis. The device itself is a standalone monitor. The performance data presented (e.g., accuracy of SpO2, NIBP, Temp, PR) is the standalone performance of the device's measurement capabilities. The "Modified Early Warning Score (MEWS)" is an algorithm within the device that generates a score based on input vital signs, operating without human intervention for its calculation.

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

For the physiological parameters (SpO2, NIBP, Temp, PR), the "ground truth" implicitly refers to the reference measurement methods used during the functional and system-level testing to determine the device's accuracy against its stated specifications. For example, for NIBP, accuracy is typically assessed against invasive blood pressure measurements or highly accurate non-invasive reference devices. For temperature, it would be against certified temperature standards. The document states the device "continue[s] to meet specifications and the performance of the device is equivalent to the predicate," which implies comparison against established, accurate measurement methods.

8. The sample size for the training set

The device described is a vital signs monitor, not a machine learning or AI-driven system that would typically require a "training set" in the context of deep learning models. Therefore, this information is not applicable and not provided.

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

As the device is not described as utilizing machine learning or AI in a way that would involve a "training set," this question is not applicable.

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