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IntelliVue Guardian Software:
The IntelliVue Guardian Software is indicated for use by healthcare providers whenever there is a need for generation of a patient record.
The IntelliVue Guardian Software is intended for use in the collection, storage and management of data from IntelliVue Cableless Measurements and IntelliVue Patient Monitors that are connected through networks.

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 Sp02 and pulse rate wirelessly.
The intended use of the IntelliVue CL SpO2 Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring, recording, and alarming of arterial oxygen saturation and pulse rate of adult and pediatric patients.
The IntelliVue CL SpO2 Pod is also intended for acquisition of arterial oxyger saturation and pulse rate data of adult and pediatric patients for a clinical information management system.
The IntelliVue 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.

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, recording, and alarming of systolic, diastvlir, and mean pressure and pulse rate of adult and pediatric, patients.
The IntelliVue CL NBP Pod is also intended for acquisition of systolic, 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.

New IntelliVue Guardian Software:
The new IntelliVue Guardian Software is a Clinical Information Management System. It collects and manages vital signs data acquired from the IntelliVue Cableless Measurements and IntelliVue patient monitors. The Guardian Software provides trending, review, reporting, notification, clinical documentation, calculations, clinical advisories including EWS deterioration status, remote viewing and operating, interfacing, storage, and printing.
The IntelliVue Guardian Software is software only product intended to be installed on a customer supplied PC or Server.

Modified IntelliVue CL SpO2 Pod:
The IntelliVue CL SpO2 Pod is a small, battery powered, wrist worn pulse oximeter device. It contains Philips FAST-Sp02 (Fourier Artifact Suppression Technology) to provide reliable saturation values under various artifact conditions including motion and low perfusion. It provides continuous cperating mode and intermittent operating mode with configurable measuring me intervals. Integrated monochrome LCD display shows measured values, measurement signal quality, battery state, and RF signal strength. It has three hardkeys for basic operation and navigation. It supports specialized Philips reusable and disposable SpO2 sensors.
The IntelliVue CL Sp02 Pod remains unchanged as it is. The modification, which is subject of this Premarket Notification, is solely limited to the labeling change in order to indicate the usage of this device together with the new Philips IntelliVue Guardian Software.

Modified IntelliVue CL NBP Pod:
The IntelliVue CL NBP Pod is a small, battery powered, noninvasive blood pressure and pulse rate measurement device. It uses oscillometric method for measuring NBP. It produces numerics for systolic, diastolic and mean blood pressure values and pulse rate. Integrated monochrome LCD Display shows measured values, battery state, and RF signal strength. It has three hardkeys for basic operation and navigation. It supports specialized Philips reusable and disposable NBP cuffs.
The IntelliVue CL NBP Pod remains unchanged as it is. The modification, which is subject of this Premarket Notification, is limited to the labeling change in order to indicate the usage of this device together with the new Philips IntelliVue Guardian Software.

The provided 510(k) summary describes the IntelliVue Guardian Software and modified IntelliVue CL SpO2 Pod and CL NBP Pod. However, it does not contain the specific details required to fully address all aspects of your request regarding acceptance criteria and a detailed study proving the device meets those criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that the device successfully met its specifications and performed reliably. Specific, quantifiable acceptance criteria (e.g., specific accuracy metrics for data collection, thresholds for system response times) and their corresponding reported performance values are not explicitly provided in this summary. The "performance" is described in general terms of functionality and clinical usefulness.

2. Sample Size for the Test Set and Data Provenance

The summary does not specify a sample size for any test set (e.g., number of patients, number of data points, or number of simulated scenarios).

Regarding data provenance:

• Country of Origin: Not specified.
• Retrospective/Prospective: Not specified for the performance tests, but the "Clinical Evaluation" implies prospective use in a clinical setting to assess usefulness and acceptance by users.

3. Number of Experts and Qualifications for Ground Truth

The summary mentions "clinical users" in the context of the "Clinical Evaluation" for user acceptance. However, it does not specify the number of experts, their qualifications (e.g., radiologists with X years of experience), or their role in establishing ground truth for any performance metrics. The ground truth for this device appears to be primarily related to system functionality and user acceptance, rather than a diagnostic output requiring expert consensus.

4. Adjudication Method

The summary does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set or for establishing ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device is a Clinical Information Management System and cableless measurement pods, which are generally not subject to MRMC studies in the same way an AI-powered diagnostic tool would be. The focus is on data collection, management, and display.

6. Standalone Performance Study

The summary mentions "Non-Clinical Performance Tests (bench testing)" and "Functionality testing on the new IntelliVue Guardian Software," which imply standalone or algorithm-only evaluation of the software and its components. However, it does not provide specific metrics or results from such a standalone study beyond a general statement of "confirmed static and dynamic performance... according to the specifications."

7. Type of Ground Truth Used

The "ground truth" for the various tests appears to be established as follows:

• Non-Clinical Performance Tests: Adherence to "specifications" for static and dynamic performance. This likely refers to predefined technical requirements and expected system behavior.
• Clinical Evaluation: "Clinical usefulness" and "acceptance by the clinical users." This suggests a qualitative assessment based on user feedback and observation in a clinical setting.
• Functionality Testing: Verification against expected functional behavior of the software and hardware components.

There is no mention of pathology, expert consensus on diagnostic outcomes, or long-term outcomes data as ground truth, as these would typically apply to diagnostic or prognostic devices.

8. Sample Size for the Training Set

This document describes a clinical information management system and monitoring devices. It does not explicitly mention a training set in the context of machine learning or AI. The product is not presented as an AI/ML device that requires a training set in the conventional sense. The "IntelliVue Guardian Software" is described as a "Software only product," and its features like "Early Warning Scoring capability" sound like rules-based algorithms rather than learned models.

9. How Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned for an AI/ML model, the question of how its ground truth was established is not applicable based on the provided text.

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