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This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate(HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.

This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, pulse rate (PR), noninvasive blood pressure (NIBP), functional oxygen saturation (SpOz), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.

This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

There are three versions of the K serial Patient Monitor, K10, K12 and K15. The primary difference is physical dimension and display TFT size; all other specifications remain unchanged. All versions have the same indications for use.

This document, a 510(k) summary for the Shenzhen Creative Industry Co., Ltd. Patient Monitor, Models K10, K12, and K15, primarily focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Creative Industry UP-7000 Patient Monitor, K123711) rather than detailing the specific acceptance criteria and study proving performance for a novel AI/software device.

Therefore, much of the requested information regarding AI device performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training) is not applicable or present in this document. This document describes a traditional medical device (patient monitor) and its components, and the "study" referred to is non-clinical and clinical testing to ensure compliance with relevant performance standards for vital sign monitoring.

However, I can extract the information that is applicable based on the provided text, particularly focusing on the performance criteria for the integrated vital sign modules.

Here's an analysis based on the provided text:

Device: Patient Monitor, Models K10, K12, K15

Indications for Use: Monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients, including ECG, heart rate (HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), and end-tidal CO2 concentration (EtCO2). Applicable for use in hospitals and clinical institutions, operation by qualified professionals only.

Study Type: This is a 510(k) submission seeking substantial equivalence to a predicate device. The "studies" involve non-clinical (safety and performance) and clinical (NIBP validation) testing against recognized standards rather than a comparative effectiveness study of a novel AI algorithm's diagnostic performance.

1. Table of acceptance criteria and the reported device performance:

The document lists performance specifications for each physiological parameter module, often directly comparing them to the predicate device. The acceptance criteria are implicitly that the devices meet or are substantially equivalent to the established performance requirements of the predicate device and relevant industry standards.

Note: The document explicitly states for the NIBP and TEMP modules that "The new [module] used in subject devices complies with the same ISO [standard] and design requirement as Predicate device." This implies the acceptance criterion for these components is compliance with the cited ISO standards (e.g., ISO 80601-2-30 for NIBP, ISO 80601-2-56 for TEMP).

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

• Test Set Sample Size:
  • For NIBP (Non-invasive sphygmomanometers) clinical validation (ISO 81060-2), this standard typically requires a minimum of 85 subjects (adults and children combined) for a full validation. While the exact number isn't stated in the provided text, the reference to this specific standard implies adherence to its sample size requirements.
  • For other parameters (SpO2, CO2, ECG, RESP, TEMP), the "performance data" section refers to IEC/ISO standards (e.g., 60601-2-49, 80601-2-61, 80601-2-55, 60601-2-27, 80601-2-56). These standards define particular requirements for the performance of the devices and often involve bench testing, simulations, or phantom studies rather than large-scale human clinical trial "test sets" in the AI sense.
• Data Provenance: Not specified in the provided text (e.g., country of origin). The testing is referred to as "Non-Clinical Study" and "Clinical Study" without detail on whether retrospective or prospective data was used, except for the NIBP clinical validation which would be prospective.

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

• Not Applicable in the AI/Software Sense: This document describes a traditional patient monitor. The "ground truth" for a patient monitor's vital sign measurements is established against recognized reference measurement methods or calibrated instruments (e.g., a known SpO2 reading from a CO-oximeter, a calibrated pressure sensor for NIBP, or a physiological simulator for ECG).
• For NIBP (ISO 81060-2): This standard for clinical validation of automated sphygmomanometers typically requires measurements to be taken by trained observers (not necessarily "experts" in the diagnostic sense, but highly skilled in manual auscultatory measurements) and compared against a reference standard. The number of observers is also specified in the standard (e.g., at least 3 observers taking sequential measurements). Their "qualification" would be their training and demonstrated proficiency in the reference method.

4. Adjudication method for the test set:

• Not Applicable in the AI/Software Sense: There is no "adjudication" of expert interpretations as seen in AI studies, as the device measures physiological parameters directly.
• For NIBP (ISO 81060-2): The standard defines specific statistical methods for comparing the device's measurements to the reference measurements, often involving Bland-Altman analysis and calculating mean difference and standard deviation. There's no "adjudication" in the sense of resolving conflicting human interpretations; rather, it's a statistical comparison to a pre-defined 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:

• Not Applicable: This device is a patient monitor, not an AI diagnostic imaging tool or a system that assists human "readers" with interpretation. Therefore, no MRMC study was performed or is relevant to this submission.

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

• Not Applicable in the AI/Software Sense: The described device functions as a standalone vital sign monitor. Its "performance" is inherently "algorithm only" in that its internal processing generates the vital sign values. However, this is not an "AI algorithm" in the context of complex pattern recognition or decision support. The performance is assessed by comparing its output against reference standards, which is a form of standalone evaluation for a monitor.

7. The type of ground truth used:

The ground truth for the performance evaluations of this patient monitor would be derived from:

• Reference Measurements/Calibrated Standards:

  • Physiological Simulators: For ECG, RESP, and potentially SpO2 and NIBP, to generate known, controlled physiological signals.
  • Calibrated Instruments: For SpO2 (e.g., CO-oximeter), CO2 (calibrated gas mixtures), NIBP (auscultatory measurements by trained observers or calibrated pressure transducers), and Temperature (calibrated thermometers).
  • In-vitro/Bench Testing: As implied by adherence to IEC/ISO performance standards, which often dictate specific test setups and reference instruments.

• Clinical Data (for NIBP): As per ISO 81060-2, the ground truth for NIBP accuracy relies on trained human observers taking simultaneous or sequential auscultatory blood pressure measurements (the "reference method").

8. The sample size for the training set:

• Not Applicable: This device is a traditional patient monitor, not an AI/machine learning device that requires a "training set" in the context of deep learning models. Its algorithms are based on established physiological signal processing principles.

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

• Not Applicable: As stated above, there is no "training set" for this type of device. The ground truth for its performance verification (as opposed to AI training) is established using validated, calibrated reference standards and methods as described in point 7.

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