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The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The subject devices are SureSigns VS3 and SureSigns VS4 multi-parameter patient monitors. Modifications include adding connectivity to IntelliVue GuardianSoftware (IGS), adding Temporal Temperature measurement to VS3, and other enhancements such as additional title bar indicators, expanded patient records pane, display patient name or primary ID, expanded QuickCapture entries, default CO2 setting alignment (VS4 only), temperature high and low alarms color change, increased SpO2 alarm delay defaults, option to prevent inadvertently clearing NBP programs, and RFID patient ID entry.

This document describes the Philips SureSigns VS3 and VS4 Vital Signs Monitors, which are multi-parameter patient monitors. The submission is a 510(k) premarket notification for modifications to previously cleared devices.

Here's an analysis of the acceptance criteria and study information provided, focusing on what can be extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "Pass/Fail criteria were based on the specifications cleared for the subject device." However, it does not explicitly list specific numerical acceptance criteria for performance metrics (e.g., accuracy ranges for NBP, SpO2, Temperature, CO2). Instead, it confirms that the device reportedly meets these implicit criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the sample size used for the test set.
It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be internal validation by Philips Medical Systems.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The testing described is verification, validation, and performance testing, which typically involves comparing device outputs to a known reference standard (e.g., calibration equipment, established measurement methods) rather than human expert-established ground truth in a clinical scenario.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the device (monitoring physiological parameters), "adjudication" in the sense of resolving discrepancies between human experts for a diagnostic task is unlikely to be relevant here. The testing would involve comparing device readings against a gold standard or reference measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices where human readers interpret images with and without AI assistance. The SureSigns VS3 and VS4 are vital signs monitors, not diagnostic imaging devices designed for human interpretation of complex data patterns in the same way. The modifications focus on software connectivity, a new temperature measurement accessory, and feature enhancements.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes "system level tests, performance tests, and safety testing from hazard analysis." This strongly implies that standalone performance testing was done for the device's functions (e.g., accuracy of NBP, SpO2, Temperature measurements). The software verification and validation, along with compliance to specific standards for temperature measurement, suggest testing of the algorithms and hardware in a standalone capacity against reference standards. However, "standalone" in the context of an AI algorithm is typically for diagnostic or predictive AI, which this device, in its described modifications, does not appear to be. It's a measurement device.

7. The Type of Ground Truth Used

The ground truth used for these types of physiological parameter monitors would typically involve:

• Reference standard instruments: Highly accurate and calibrated devices used to establish the true value of parameters like NBP, SpO2, and Temperature.
• Known physical inputs: For example, precise temperature probes, blood pressure simulators, or SpO2 simulators with defined oxygen saturation levels.
• Compliance with industry standards: The mention of ISO 80601-2-56 for temperature indicates that the ground truth for temperature measurement accuracy would be established by following the specific protocols and reference measurements outlined in that standard.

The document does not explicitly state "expert consensus" or "pathology" as ground truth, which are more relevant for diagnostic AI applications.

8. The Sample Size for the Training Set

The document does not describe any "training set." This is because the device, based on the provided information, is a vital signs monitor and not an AI/ML-based diagnostic or predictive system that requires a training set for model development. The focus is on measurement accuracy and software functionality.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, this information is not applicable/provided.

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The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The subject devices are multi-parameter patient monitors, specifically the SureSigns VS3 and SureSigns VS4. Modifications to the VS4 include the addition of CO2, SpHb, Respiratory Rate RRa, and Masimo SpO2 measurements. Both VS3 and VS4 have the QuickNBP mode added.

This is a 510(k) summary for Philips SureSigns VS3 and VS4 vital signs monitors, describing modifications to add additional measurement capabilities. The provided text, however, does not contain information about specific acceptance criteria or a detailed study proving the device meets said acceptance criteria with numerical performance data. It broadly states that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject device. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence."

Therefore, I cannot fulfill all parts of your request with the provided information.

However, based on the information available, here's what can be extracted:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in a table or numerical format. The document states that "Pass/Fail criteria were based on the specifications cleared for the subject device and test results showed substantial equivalence," implying that the devices met pre-defined specifications. However, the exact criteria and corresponding performance metrics are not detailed.

• Sample Size for Test Set and Data Provenance: This information is not explicitly stated in the provided text.

• Number of Experts and Qualifications: This information is not mentioned in the provided text.

• Adjudication Method: This information is not mentioned in the provided text.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication that an MRMC study was done. The device is a vital signs monitor, which typically involves direct measurement rather than interpretation by multiple human readers in the way an AI-assisted diagnostic tool might.

• Standalone (Algorithm Only) Performance Study: The document mentions that the new features are achieved by using OEM modules that are "FDA cleared under Kxxxxxx." This implies that the performance of these modules as standalone components was already established in their respective clearances. For instance, for CO2 measurement, the Oridion microMediCO2 OEM module was cleared under K094012; for SpHb, RRa, and Masimo SpO2, the Masimo Rainbow SET Radical 7R CO-Oximeter was cleared under K100428; and for Temporal Temperature, the Exergen TemporalScanner Thermometer was cleared under K011291. The QuickNBP mode is described as based on the "same algorithm that provides the regular NBP measurements" in the existing devices. Therefore, while not explicitly called a "standalone study," the reliance on previously cleared, established technologies suggests that their standalone performance has been demonstrated.

• Type of Ground Truth Used: Not explicitly stated for the overall device's performance. However, for the OEM modules incorporated, their original clearances would have involved appropriate ground truth methods for each physiological parameter (e.g., direct measurement for temperature, arterial blood gas analysis for SpO2 calibration, etc.).

• Sample Size for Training Set: This information is not applicable as the document describes hardware modifications incorporating existing, cleared OEM modules and leveraging existing algorithms. It does not mention the development or training of new algorithms that would require a distinct training set.

• How Ground Truth for Training Set Was Established: Not applicable given the nature of the device modifications.

In summary, the provided text primarily focuses on the substantial equivalence argument for modifications to existing vital signs monitors by integrating previously cleared OEM modules and leveraging existing algorithms. It does not contain the detailed performance study information with specific acceptance criteria, sample sizes, expert involvement, or adjudication methods that your request entails for a newly developed AI/diagnostic device.

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