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The purpose and function of the CLEO patient monitor is to monitor basic physiological parameters including

• NIBP (systolic and diastolic)
• SpO2
• ETCO2

The target population is for adults only.

It can be used in all hospital areas and hospital-type facilities. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The CLEO monitor is a comprehensive monitoring system with two or three traces compiling, and processing, analyzing and displaying data from up to three different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The CLEO Patient monitor can be powered by an internal battery pack that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

The associated accessories include:

• Sp02 Finger Sensors
• NIBP Monitor
• Blood Pressure Cuff
• ETCO2 Module

The provided document is limited to the FDA 510(k) summary for the CLEO Patient Monitor. This document outlines the device's regulatory status, intended use, and a summary of performance testing to support substantial equivalence to a predicate device.

It does not contain the detailed information needed to fully answer all aspects of your request, particularly regarding specific acceptance criteria values and a comprehensive study report with ground truth establishment and expert involvement, as would be expected for a comparative effectiveness study or a rigorous standalone algorithm performance study.

The information provided largely focuses on demonstrating compliance with recognized standards for medical devices rather than detailed clinical performance studies for a diagnostic algorithm.

Here's a breakdown of what can be extracted and what is missing:

Description of Acceptance Criteria and Device Performance

The document describes various performance tests conducted to support the substantial equivalence of the CLEO Patient Monitor. However, it does not explicitly state numerical "acceptance criteria" for each parameter in the way one might expect for a diagnostic algorithm. Instead, it lists the standards of compliance that the device met. The "reported device performance" is implicitly that the device complied with these standards.

Table of Acceptance Criteria (as inferred from Standards of Compliance) and Reported Device Performance:

Missing Information:

The document does not provide the following information that would be necessary to answer the remaining parts of your request:

1. Sample size used for the test set and the data provenance: The document mentions "performance tests" for NIBP, SpO2, and ETCO2 but does not specify the number of subjects, the type of data (e.g., patient data, simulated data), or its origin (e.g., country, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present. The testing described seems to rely on standardized methods and calibrated equipment rather than expert human assessment for ground truth.
3. Adjudication method: Not applicable/not mentioned, as there isn't a human-expert-based ground truth outlined.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: No MRMC study is mentioned. This device is a physiological monitor, not a diagnostic imaging AI algorithm typically requiring MRMC studies.
5. If a standalone performance study was done: The document describes various performance tests ("Mechanical Testing," "SPO2 Performance Test," "NIBP Performance Test," "CO2 Measurement Accuracy and Drift") which could be considered standalone performance assessments against established standards. However, it's not a standalone algorithm performance in the sense of a machine learning model's output being compared to ground truth.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the physiological measurements would be derived from highly accurate reference instruments or test setups that simulate physiological conditions according to the respective standards (e.g., a calibrated pressure transducer for NIBP, a pulse oximeter simulator for SpO2, a gas analyzer for ETCO2). Expert consensus, pathology, or outcomes data are not relevant for establishing ground truth for these types of physiological measurements.
7. The sample size for the training set: This device is a traditional physiological monitor, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" would be the engineering design, calibration, and validation against known physical and physiological principles.
8. How the ground truth for the training set was established: Not applicable, as it's not an AI/ML device with a training set.

In summary: The provided document is a 510(k) summary for a traditional patient monitor. It focuses on demonstrating compliance with established medical device safety and performance standards for its physiological measurement capabilities (NIBP, SpO2, ETCO2). It does not describe an AI/machine learning algorithm or the types of studies (MRMC, expert consensus for ground truth, training/test sets for AI) that your request specifically asks about. The "acceptance criteria" are implied by compliance with the listed international and national standards.

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