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The Accutorr 7/VS-900/VS-900c 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/VS-900c Vital Signs Monitors are composed of the main unit and parameter modules. The main unit has the following functions:

• Provides operation interface, such as keys, touchscreen, and display screen.
• Communicates with the parameter modules.
• Delivers the setup commands of parameters to the parameter modules.
• Obtains the parameter measurements.
• Displays and stores the parameter numeric measurements and waveforms, and sends the data to Mindray's central monitoring system or Mindray's eGateway.

The parameter measurement modules include Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2). Their measurement principles are as follows:
Pulse Oxygen Saturation (SpO2) monitoring is a non-invasive technique used to determine the amount of oxygenated hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the emitter side of the probe is partly absorbed when it passes through the monitored tissue. The amount of transmitted light is detector side of the probe. When the pulse active part of the light signal is examined, the amount of light absorbed by the hemoglobin is measured and the pulse oxygen saturation can be calculated. The SpO2 module processes the electrical signal and displays a waveform and numeric values for SpO2 and pulse rate.
The monitor uses the oscillometric method for measuring the non-invasive blood pressure (NIBP). NIBP measurement is based on the principle that pulsatile blood flow through an artery creates oscillations of the arterial wall. The oscillometric device uses a blood pressure cuff to sense these oscillations, which appear as tiny pulsations in cuff pressure. The Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish. The oscillometric method measures the mean pressure and determines the systolic and diastolic pressures.
CO2 monitoring is based on measuring the absorption of infrared (IR) light of specific wavelengths. CO2 has its own absorption characteristic and the amount of light passing to the gas probe depends on the concentration of the measured CO2. When a specific band of IR light passes through respiratory gas samples, some of the IR light will be absorbed by the CO2 molecules. The amount of IR light transmitted after it has been passed through the respiratory gas sample is measured with a photodetector. From the amount of IR light measured, the concentration of CO2 is calculated.
The monitor supports two kinds of TEMP module: Mindray TEMP and Exergen TEMP. Different TEMP modules cannot be used at same time. The customers need to choose one kind of TEMP module before they buy the monitor.

• Mindray TEMP Module has two measuring modes, Monitor mode and Predictive mode.
• In the Monitor mode, the thermal resistance in the probe reflects the subject's temperature by sensing the temperature change of the subject according to the thermal equilibrium principle. In the Predictive mode, the subject's temperature is predicted by the temperature rise curve (which is obtained by collecting multiple temperature measurements) at the time of initial thermal conduction.
• The Exergen Temperature Module is an infrared thermometer designed for accurate and completely non-invasive temperature assessment by scanning the temporal artery (TA). Temperature is measured by gently swiping the Temporal Scanner across the forehead, and includes a momentary touch of the probe to the neck area behind the ear lobe to account for any cooling of the forehead as a result of diaphoresis. The patented arterial heat balance technology (AHB™) automatically measures the temperature of the skin surface over the artery and the ambient temperature. It samples these readings approximately 1000 times a second, ultimately recording the highest temperature measured (peak) during the course of the measurement. The Temporal Scanner emits nothing - it only senses the natural thermal radiation emitted from the skin.

Here's a breakdown of the acceptance criteria and study information for the Accutorr 7/VS-900/VS-900c Vital Signs Monitor, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K170712) for the existing features and compliance with relevant standards for modifications. Therefore, the "acceptance criteria" for the subject device are largely defined by matching or exceeding the performance and specifications of the predicate device and meeting consensus standards.

Here's a table focusing on the key physiological parameters mentioned in the device description and the "Device Comparison Table," identifying areas where performance is explicitly stated or where changes were made.

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

The document primarily refers to "Non-clinical testing" which includes:

• EMC and Electrical Safety Testing: Performed on the "subject device" to confirm continued compliance with standards after modifications. This is bench testing, not involving human subjects.
• Performance Testing - Bench: Functional and system-level testing on the "subject devices." This is bench testing, not involving human subjects.
• Software Verification and Validation Testing: This is testing of the software itself, not involving human subjects and no specific sample size of patient data is mentioned for testing performance on diagnostic tasks.

For the physiological parameter measurements (SpO2, NIBP, TEMP, CO2), the submission relies on the substantial equivalence to the predicate devices and applicable consensus standards rather than new clinical trials with patient sample sizes.

• For NIBP, the expanded display range is stated to "comply with IEC 80601-2-30: 2013," indicating adherence to a standard that typically specifies requirements for accuracy testing (often involving a specified number of subjects across different age groups, but this specific study's details are not provided in this summary).
• The Exergen Temperature Module is a previously cleared OEM module (K011291), meaning its performance was established in its own 510(k) submission.

Data Provenance: Not explicitly stated as the testing described is primarily bench/software related. For the incorporated OEM Exergen module, its original clearance (K011291) would hold the provenance for temperature accuracy studies. For NIBP and SpO2 metrics, "compliance with consensus standards" implies those standards' requirements for testing (which might involve human subjects to validate accuracy against a reference method) were met, but details of such studies are not in this summary.

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)

Not applicable. The described testing is primarily non-clinical (bench and software testing) and relies on meeting pre-defined technical specifications and consensus standards, not on expert adjudication of diagnostic outcomes. For physiological measurements, validation is typically against a reference instrument or method, not expert consensus.

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

Not applicable, as the document describes technical performance testing against specifications and standards, not a diagnostic study requiring expert adjudication or ground truth establishment in a clinical setting.

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

Not applicable. This device is a vital signs monitor, not an AI-assisted diagnostic imaging or interpretation device. The "Modified Early Warning Score (MEWS)" is a clinical assessment tool generated by combining measured vital signs, not an AI-driven interpretation that would require an MRMC study.

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

The device itself is a standalone vital signs monitor. Its performance for individual parameters (SpO2, NIBP, TEMP, CO2) is evaluated against technical specifications and standards (as shown in the table). Its function is to measure and display parameters, not to provide an AI-driven diagnosis or recommendation in isolation. The MEWS feature is an algorithmic calculation based on the measured parameters. The performance of these calculations themselves would be validated against the MEWS algorithm's defined logic.

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

For the non-clinical testing described:

• EMC and Electrical Safety: Ground truth is defined by the limits and test methods specified in the cited international standards (e.g., AAMI ANSI ES 60601-1, IEC 60601-1-2).
• Functional and System Level Performance: Ground truth is the device's technical specifications and the requirements of cited consensus standards (e.g., IEC 80601-2-30 for NIBP, IEC 60601-2-49 for patient monitoring). This generally involves comparison against calibrated reference equipment or methods.
• Software V&V: Ground truth is the software requirements specification and design documents.

8. The sample size for the training set

Not applicable. The document describes a traditional medical device (vital signs monitor), not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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