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Indications for Use for SureSigns VS3 Vital Signs Monitor

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.

Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric, Neonatal)

Contraindications: Not for transport outside the healthcare facility

Indications for Use for SureSigns VS4 Vital Signs Monitor

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.

Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric. Neonatal); CO2 (Adult, Pediatric. Neonatal); RRa (Adult, Pediatric); SpHb (Adult, Pediatric)

Contraindications: Not for transport outside the healthcare facility

The subject VS3 and VS4 will be modified with the current QuickAlert to include On-device multi-parameter configurable Modified Early Warning Scores (MEWS).

The provided text describes a 510(k) premarket notification for Philips SureSigns VS3 and VS4 Vital Signs Monitors. This document asserts substantial equivalence to previously cleared devices rather than providing a detailed study proving the device meets specific acceptance criteria with new clinical trials.

The modifications to the devices (VS3 and VS4) involve adding "On-device multi-parameter configurable Modified Early Warning Scores (MEWS)" to the existing QuickAlert functionality. The document states that there are no additions, deletions, or changes to the current measurements or alarming, nor any specification changes to the current SureSigns VS3 or SureSigns VS4 monitors.

Therefore, the information you requested regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of new clinical performance outcomes, is not explicitly detailed in this 510(k) summary. The summary focuses on demonstrating that the modified devices function as intended without adverse impact on safety or effectiveness and are substantially equivalent to their predicate devices.

However, I can extract information related to the verification, validation, and testing activities mentioned, which implicitly served to meet the acceptance criteria for the added MEWS functionality and device safety/performance.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of explicit acceptance criteria with quantitative performance metrics for the added MEWS functionality. It generally states:

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

The document states: "Testing involved system level tests, performance tests and tests according risk assessment." It does not specify the sample size for the test set (e.g., number of patients or data points) or the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) for a modification to a vital signs monitor primarily focused on a new scoring algorithm, the testing likely involved a combination of simulated data, historical patient data for algorithm validation, and/or in-house testing, rather than a large prospective clinical study.

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

This information is not provided in the document. For a MEWS system, ground truth would typically involve clinical experts determining actual patient deterioration or risk, but the document does not elaborate on how the MEWS algorithm's performance was validated against expert judgment.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A MRMC comparative effectiveness study was not performed or reported in this 510(k) summary. The document focuses on the technical verification of the device and its software modification, not a study evaluating human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document implies that "performance tests" were conducted, which would likely include testing the MEWS algorithm's output in a standalone manner. However, it does not explicitly describe a dedicated standalone study with specific metrics for the algorithm's performance independent of user interpretation or intervention. The MEWS is "On-device," suggesting it provides scores for healthcare professionals to act upon, but its isolated performance metrics are not detailed.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for evaluating the MEWS functionality. For a risk-scoring system like MEWS, common ground truths might include subsequent clinical events (e.g., ICU admission, cardiac arrest, death), expert clinical assessment, or established clinical criteria for deterioration.

8. Sample Size for the Training Set

The document does not specify the sample size for any training set. It's common for MEWS algorithms to be based on established clinical scoring systems rather than de novo machine learning models requiring extensive training data. If machine learning was used for the "configurable" aspect, the training set size is not disclosed.

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

Since no training set is mentioned, the method for establishing its ground truth is also not provided.

In summary, this 510(k) notification emphasizes the substantial equivalence of the modified vital signs monitors to their predicate devices, particularly concerning the addition of configurable MEWS. It mentions verification and validation testing to ensure the device performs as specified and meets safety and effectiveness standards, but it lacks detailed quantitative data on clinical performance, sample sizes, expert involvement, or ground truth methodologies that would typically be found in a comprehensive clinical study report.

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