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The SunTech CT40 (Model 260) is a non-invasive oscillometric spot check vital signs device. The CT40 is capable of measuring and displaying brachial systolic and diastolic blood pressure, heart rate, percent oxygenated hemoglobin (SpO2) and body temperature on children 3 years of age to adults. This device is intended for use by a qualified clinician when it is necessary to take one or more vital signs measurements on a patient. The CT40 is only for measurement, recording, and display. It makes no specific diagnoses.

The CT40 (Model 260) is designed to non-invasively measure systolic and diastolic blood pressure, pulse rate, temperature, and oxygen saturation (SpO2) for adult and pediatric patients. All blood pressure, pulse, temperature, and SpO2 values are displayed on a large, easy-to-read LCD. The device has a rechargeable battery and may be use as a desktop unit or on a mobile stand. The CT40 (Model 260) Spot-check Vital Signs Device can perform automatic blood pressure, pulse oximetry and body temperature measurements for clinical professionals. The CT40 (Model 260) consist of a base unit with NIBP, display, control buttons and knob housed in an ABS plastic enclosure. The left side of the unit has a removable panel were a SpO2 module may be connected. And the right side of the unit has a removable panel where a temperature module may be connected. For measuring blood pressure, a blood pressure cuff is placed around the patient's non-dominant upper arm. The cuff is automatically inflated and the blood pressure is determined by the oscillometric method, which senses pressure waves in the artery when occluded by pressure in the cuff. Measurement of the frequency of the pressure waves enables heart rate to also be measured. The pulse oximetry function non-invasively measures the patient's percent oxygen saturation of arterial hemoglobin using principles of plethysmography via a SpO2 sensor placed on the patient's finger. Temperature can be measured using one of two different kinds of temperature technology. The oral/axillary/rectal temperature probe contains a thermistor that generates a voltage based on changes in temperature, and these voltages are measured by the temperature circuitry. The touchless infrared temperature probe detects radiated infrared energy from the temporal artery. The CT40 (Model 260) is a portable device, approximately 205 x 190 x 140 mm in size and weighs approximately 1440 g without battery. Control buttons allow the user to stop/start a BP measurement, save a set of measurements to memory, change between BP modes, and return to the home screen. There is also a selection knob that is used to scroll and select different device options. The backlit LCD display shows the user device status and measurement information. The device uses a microprocessor with firmware, which is not accessible to the user. The unit is powered by AC mains power and rechargeable lithium-ion battery. Two USB-A port connections can be used to connect, an optional printer, barcode scanner or Wi-Fi dongle. There is also RJ11 Ethernet port for network connectivity, and a mini-USB port used to connect the device to a PC or laptop for advanced device configuration.

The provided text describes the SunTech CT40 Spot-check Vital Signs Device (Model 260), but it does not contain the specific acceptance criteria or the full study details that prove the device meets those criteria, as typically found in a clinical study report.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards. While it lists standards related to accuracy for NIBP, SpO2, and temperature, the actual performance data and acceptance criteria for these measurements are not explicitly detailed in the provided information.

Therefore, I cannot fully complete all sections of your request based on the given input. However, I can extract what is available and highlight what is missing.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific numerical acceptance criteria for clinical accuracy (e.g., mean difference and standard deviation in mmHg for NIBP, or accuracy ranges for SpO2 and temperature) are not explicitly stated in the provided text. The "Performance" row in the comparison table mentions the performance is "the same as SunTech 247" for NIBP, ChipOx SpO2, and Covidien temperature, and "similar to Welch Allyn" for Massimo SpO2 and HuBDIC IR temperature, but it does not quantify these performances.

The document states that the device was tested to "ISO 81060-2: 2013, Non-invasive sphygmomanometers -Part 2: Clinical investigation of automated measurement type," "ISO 80601-2-56: 2009 +A1: 2013, Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement," and "ISO 80601-2-61: 2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment." These standards define the acceptance criteria for accuracy.

2. Sample Size Used for the Test Set and Data Provenance

Missing Information: The document mentions "97-0143-XX-CV-81060-2" as the "NIBP Clinical Validation Study." However, the sample size for this test set, country of origin of the data, and whether it was retrospective or prospective are not provided in the excerpt. Only the existence of the study is noted.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Missing Information: This information is not available in the provided 510(k) summary. For blood pressure, ground truth is typically established by trained observers using a reference sphygmomanometer (mercury or auscultatory method), not "experts" in the sense of diagnosticians. For SpO2 and temperature, the ground truth would come from referencemethods. The qualifications of the individuals involved in collecting reference measurements for any clinical validation are not described here.

4. Adjudication Method for the Test Set

Missing Information: This information is not provided in the excerpt. For NIBP validation against a reference standard, agreement between multiple observers is usually assessed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No, a MRMC comparative effectiveness study was not done. The device is a "spot-check vital signs device" and its performance is evaluated in a standalone manner against reference standards, not as an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, there is no AI assistance or effect size on human reader improvement to report.

6. If a Standalone (Algorithm Only) Performance Study was Done

Yes, a standalone study was done for the NIBP component. The document explicitly lists:

• "97-0143-XX-CV-81060-2 NIBP Clinical Validation Study"
  This indicates that the NIBP measurement algorithm itself underwent clinical validation according to ISO 81060-2. The document also states that performance for SpO2 and temperature are "the same as" or "similar to" predicate devices, implying their algorithms also met the respective ISO standards (ISO 80601-2-61 for SpO2 and ISO 80601-2-56 for temperature).

7. The Type of Ground Truth Used

Based on the mentioned standards:

• For NIBP (ISO 81060-2): The ground truth for blood pressure measurements generally involves simultaneous auscultatory measurements by human observers using a mercury or other validated reference sphygmomanometer.
• For SpO2 (ISO 80601-2-61): The reference method for SpO2 is often considered to be co-oximetry measurements of arterial blood samples.
• For Temperature (ISO 80601-2-56): The reference method for body temperature depends on the site (rectal, oral, etc.) and is typically a highly accurate reference thermometer.

However, the document does not explicitly state the specific ground truth methods or their origin within the context of the CT40's studies. It merely references the standards that would dictate these methods.

8. The Sample Size for the Training Set

No training set is mentioned or applicable here. This device is a vital signs monitor, not an AI/machine learning diagnostic device that typically requires a large training dataset for model development. The algorithms for NIBP, SpO2, and temperature measurement are based on established physiological principles and signal processing, not on machine learning from a 'training set'.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no mention or indication of a training set as this is not an AI/ML-based diagnostic device.

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