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Truscope Elite A8, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3: The Truscope series patient monitors (Truscope Elite A8, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3) is 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) and Cerebral State Index (CSI). 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.

Truscope II and MINI: Truescope Series Patient Monitor (Truscope II and MINI) is intended to be used for monitoring. displaying, reviewing, storing and alarming of multiple physiological parameters including ECG Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. Truescope Series Patient Monitor (Truscope II and MINI) is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance. Note: Truscope MINI does not have functions of Invasive Blood Pressure and Carbon Dioxide

Truscope Classic: Truescope Series Patient Monitor (Truscope Classic) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2). Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. They are not intended for helicopter transport or hospital ambulance.

The proposed device Truscope Patient Monitor is change from the Paitent Monitor manufactured by Guangdong Biolight Meditech Co., Ltd, all models included in this submission has exactly same design, materials, and manufacture process with their original model, only different is the model name and device name.

Here's a breakdown of the acceptance criteria and study information for the Truscope Patient Monitors based on the provided text:

Preamble: The provided document is a 510(k) summary for a patient monitor. For this type of device, the "study that proves the device meets the acceptance criteria" refers to non-clinical bench tests and adherence to recognized standards, rather than clinical trials with human subjects for novel AI algorithms. The acceptance criteria themselves are the performance requirements set by these standards. The device is a "Truscope Patient Monitor," which includes various models (Truscope Elite A8, A6, A5, A3, Truscope II, Truscope MINI, and Truscope Classic). The submission emphasizes that these models have the "exactly same design, materials, and manufacture process" as their previously cleared predicate devices, differing only in model/device name. Therefore, much of the "proof" revolves around demonstrating that these new models maintain the performance established by their predicates.

1. Table of Acceptance Criteria and the Reported Device Performance

Given that this is a 510(k) for patient monitors, the acceptance criteria are generally established by recognized consensus standards. The document states that "Bench tests were conducted to verify that the proposed device met all design specifications" and "the test results demonstrated that the proposed device complies with the following standards." The reported device performance is implicitly that it complies with these standards and is Substantially Equivalent (SE) to the predicate devices.

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 refers to "bench tests" to verify compliance with design specifications and standards.

• Sample Size for Test Set: Not explicitly stated as a number of measurement points or patient cases. For a medical device like a patient monitor, "sample size" in this context would likely refer to the quantity of devices or components tested, and the range of input signals (e.g., simulated ECG waveforms, blood pressure values) applied during testing for each parameter. The document does not provide these specifics.
• Data Provenance: Not specified. As the manufacturer is Guangdong Biolight Meditech Co., Ltd. (China), it is highly probable that the non-clinical bench testing took place in China. The nature of bench testing implies it is controlled, simulated data rather than patient data, making it neither retrospective nor prospective in the typical clinical sense.

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 applicable or provided for this type of submission. Bench tests for patient monitors typically rely on calibrated reference equipment and standardized test signals to establish "ground truth" for electrical, mechanical, and physiological parameter measurement accuracy, rather than expert human interpretation of complex data.

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

This information is not applicable or provided. Adjudication methods are typically used when human interpretation of complex data (e.g., images for a diagnostic AI) is involved in establishing ground truth. For technical performance testing of a patient monitor based on international standards, calibrated instruments serve as the reference.

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 information is not applicable. The device is a patient monitor, not an AI-powered diagnostic tool, and the submission is a 510(k) for substantial equivalence based on technical performance to predicate devices and adherence to standards, not a comparative effectiveness study involving human readers or AI assistance.

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

This information is not applicable in the context of advanced AI algorithms. While the device contains algorithms for ECG analysis (arrhythmia, ST segment), SpO2, NIBP, etc., these are integrated functionalities of a patient monitor, and their "standalone" performance is assessed through compliance with the relevant IEC/AAMI standards for those parameters (e.g., AAMI EC57 for ECG algorithms), which the document states has been met via bench testing. The term "standalone" in AI often implies a distinct algorithm separate from a human workflow, which isn't the primary focus here.

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

For the bench tests conducted to verify the device's performance against the listed standards, the ground truth would be established by:

• Calibrated reference equipment: For electrical safety, EMC.
• Traceable test signals/simulators: For physiological parameters like ECG waveforms (known heart rate, arrhythmia types, ST deviation), blood pressure pressures, SpO2 saturation levels, temperature, and gas concentrations. These simulators generate signals with known, precise values which the device is expected to measure accurately.

8. The sample size for the training set

This information is not applicable or provided. The device is a patient monitor, not a machine learning model developed with a training set of data in the contemporary AI sense. Its algorithms are based on established signal processing principles and are validated against industry standards.

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

This information is not applicable or provided. As mentioned above, there is no "training set" in the context of developing a machine learning model. The algorithms embedded in the patient monitor (e.g., for arrhythmia detection) are based on pre-defined criteria and validated against standardized test signals.

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