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IntelliVue CL SpO2 Pod:
The IntelliVue CL SpO2 Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters SpO2 and pulse rate wirelessly.
The intended use of the IntelliVue CL SpO3 Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring, and recording of, and to generate alarms for, arterial oxygen saturation and pulse rate of adult and pediatric patients.
The IntelliVue CL SpO2 Pod is also intended for local attended monitoring of, and to generate alarms for, arterial oxygen saturation and pulse rate of adult and pediatric patients.
The IntelliVue CL SpO2 Pod is also intended for acquisition of arterial oxygen saturation and pulse rate data of adult and pediatric patients for a clinical information management system.
The Intelli Vue CL SpO2 Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device.
Local attended monitoring refers to situations where clinical staff is close to the patient such that acoustic alarming of the Intelli Vue CL SpO2 Pod will be noticed. Example: In-hospital transport of a patient by hospital staff to a procedure room.

IntelliVue CL NBP Pod:
The IntelliVue CL NBP Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters non-invasive blood pressure and pulse rate wirelessly.
The intended use of the IntelliVue CL NBP Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring and recording of, and to generate alarms for, systolic, diastolic, and mean pressure, and to measure pulse rate of adult and pediatric patients.
The IntelliVue CL NBP Pod is also intended for local attended monitoring of, and to generate alarms for, systolic, diastolic, and mean pressure, and to measure pulse rate of adult and pediatric patients.
The IntelliVue CL NBP Pod is also intended for acquisition of svstolic, diastolic, and mean pressure and pulse rate data of adult and pediatric patients for a clinical information management system.
The IntelliVue CL NBP Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device.
Local attended monitoring refers to situations where clinical staff is close to the patient such that acoustic alarming of the Intelli Vue CL NBP Pod will be noticed. Example: In-hospital transport of a patient by hospital staff to a procedure room.

IntelliVue Patient Monitors MP5. MP5T, and MP5SC:
The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
The MP5, MP5SC and MP5T monitors are also intended for use during patient transport inside the hospital environment; only the MPS monitor is for use during patient transport outside of the hospital environment. The MP5, MP5SC and MP5T when used with the TRx4841 A/TRx4851 A IntelliVue Telemetry System Transceiver or with the Intelli Vue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.
The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.
The ECG measurement is intended to be used for diagnostic recording of rhvthm and detailed morphology of complex cardiac complexes (according to AAMIEC II).
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.
The SSC Sepsis Protocol in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.
The Integrated Pulmonary index (IPI) is intended for use with adult and pediatric (I to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring. The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue CL SpO2 Pod is a small, battery powered, wrist worn pulse oximeter device for cableless monitoring of patients. It contains Philips FAST-SpO2 (Fourier Artifact Suppression Technology) to provide reliable saturation values under various artifact conditions including motion and low perfusion. It uses a measurement principle that is based on the specific absorption characteristics of oxyhemoglobin and deoxyhemoglobin and the pulsating arteriolar vascular bed at the measurement site. It provides continuous operating mode and intermittent operating mode with configurable measurement intervals. The integrated monochrome LCD display shows measured values, measurement signal quality, battery state, and RF signal strength. It communicates measurement values and other information to an IntelliVue Patient Monitor or an IntelliVue Information Center via a telemetry device. It also acquires SpO2 and pulse rate data for a clinical information management system. It has three hardkeys for basic operation and navigation. It supports specialized Philips reusable and disposable SpO2 sensors.
The IntelliVue CL NBP Pod is a small. battery powered, non-invasive blood pressure and pulse rate measurement device for cableless monitoring of patients. It uses oscillometric method for measuring NBP. It produces numerics for systolic. diastolic and mean blood pressure values and pulse rate. The integrated monochrome LCD Display shows measured values, battery state, and RF signal strength. It communicates measurement values and other information to an IntelliVue Patient Monitor or an IntelliVue Information Center via a telemetry device. It also acquires systolic, diastolic, and mean pressure and pulse rate data for a clinical information management system. It has three hardkeys for basic operation and navigation. It supports specialized Philips reusable and disposable NBP cuffs and air hoses. Both measuring devices the CL SpO2 Pod and the CL NBP Pod can also be controlled from an assigned IntelliVue Patient Monitor, an IntelliVue Information Center via a telementy device, or from the IntelliVue GuardianSoftware via the hospital IT infrastructure. They communicate with the compatible devices using a wireless Short Range Radio (SRR) interface in the 2.4 GHz ISM frequency band.
The modification to the IntelliVue CL SpO2 Pod and CL NBP Pod enables local physiological alarm indication on these devices for local attended monitoring without a host patient monitor, e.g. during in-hospital transport attended by a care giver. This notifies clinical personnel about possibly threatening situations for a patient.
The modification to the IntelliVue CL SpO2 Pod introduces pulse tone and pulse tone modulation locally at the IntelliVue CL SpO2 Pod to allow clinical personnel to hear deviations of the patients pulse frequency and saturation levels also during local attended monitoring (without a patient monitor).
The IntelliVue CL NBP Pod has additionally been modified in order to enhance accuracy of diastole and Mean Arterial Pressure (MAP) measurements in order to enhance the margin to the limits specified in the recognized consensus standards ANSI/AAMI SP10 and ISO 81060-2.
To supplement the range of measurement accessories, the CL NBP Pod has also been validated for use with a series of additional, legally marketed Philips cuffs. To connect the additional Philips cuffs a new adapter hose, the Mobile CL Air Hose-Bayonet Connector (model No .: 989803187431), has been setup and added to the list of accessories. As the legally marketed Philips Mobile CL Extension Air Hose, the new hose is explicitly intended for use with the IntelliVue CL NBP Pod.
The IntelliVue Patient Monitors MP5, MP5T, and MP5SC consist of 8.4" TFT LCD display unit including built-in central processing unit (CPU) and multiple physiological measurements. All monitor models share the same architecture of CPU units and the same software is executed on each monitor. They are robust, portable, lightweight, compact in size and modular in design, with interfaces to dedicated external measurement devices. The MPS. MP5T and MP5SC monitors have varying measurement sets and network capabilities. All models can be used with adult, pediatric and neonatal patients in a hospital and transport environment. They store data in trend, event, and calculation databases. Tabular trends (vital signs) can be watched on display and documented on a printer.
The MP5 monitor provides a comprehensive set of basic physiological measurements: NBP, SpO2, and optionally ECG, invasive blood pressure, predictive temperature, standard temperature and CO2. Through networking it provides information integration, documentation and information access.
The MP5T monitor is intended for use together with a telemetry device. It has no ECG measurement of its own but does have NBP and optionally SpO2 and predictive temperature. When the telemetry device is directly connected to the MP5T. the measurements from the MPST are transmitted with those from the telemetry device (ECG and optionally SpO2) to the Information Center.
The MP5SC monitor is customized for use as a multi-patient spot check monitor. It has SpO2 and NBP and optionally predictive temperature or Microstream CO2. A telemetry device can be connected via short range radio (SRR) to the MP5SC to provide an ECG measurement.
When used together with the IntelliVue CL SpO2 Pod and CL NBP Pod. the MP5. MPST, and MPSSC monitors receive via Short Range Radio (SRR) interface measurement values. The measurement data is displayed and recorded on the patient monitors. The patient monitors also receive technical and physiological alarms generated in the CL SpO2 and NBP Pods for their audible and visual indication on the monitors. In addition, the patient monitors can control some functions of the CL SpO2 and NBP Pods via SRR link.
The common software of the IntelliVue Patient Monitors MP5. MP5T. and MP5SC has slightly been modified to allow the operator to start and to end local attended monitoring of the IntelliVue CL SpO2 Pod and CL NBP Pod.

The provided text is a 510(k) summary for the Philips IntelliVue CL SpO2 Pod, CL NBP Pod, and IntelliVue Patient Monitors MP5, MP5T, MP5SC. This document describes regulatory information, device descriptions, and summaries of verification and validation activities.

However, the document does not describe an AI/ML-based device. It pertains to physiological monitoring devices (pulse oximeters, non-invasive blood pressure monitors, and patient monitors). The performance validation activities described are for these traditional medical devices, focusing on accuracy against standards, durability, and usability, rather than AI model performance metrics like sensitivity, specificity, or AUC based on ground truth established by expert consensus or pathology.

Therefore, I cannot extract the information required by your questions, such as:

1. A table of acceptance criteria and reported device performance (in the context of AI metrics).
2. Sample size used for the test set and data provenance (for AI model testing).
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study and effect size for human readers with/without AI assistance.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI models.
8. Sample size for the training set (for AI models).
9. How the ground truth for the training set was established (for AI models).

The document states: "The IntelliVue CL NBP Pod has additionally been modified in order to enhance accuracy of diastole and Mean Arterial Pressure (MAP) measurements in order to enhance the margin to the limits specified in the recognized consensus standards ANSI/AAMI SP10 and ISO 81060-2." and "The modified IntelliVue CL NBP Pod met all safety and efficiency requirements and demonstrated that the accuracy requirements (measured by means of mean error and standard deviations, using the same Arm Sequential Method - Dual Observer - in Comparison to a Mercury Reference Sphygmomanometer) for the number of subjects..." This indicates traditional medical device accuracy validation, not AI model performance.

In summary, the provided document does not contain information about an AI/ML-based device and its associated acceptance criteria and study proving it meets those criteria in the context of AI/ML performance.

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