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The Early Vue VS30 is intended to measure, display, alarm and, record physiological information of adult, pediatric and neonatal patients in hospitals and in out-of-hospital patient care is administered by a healthcare professional (such as clinics, outpatient surgery facilities, long-term care facilities, and physician offices). It is not intended for use in mobile settings such as ambulances and aircraft. Clinical users may use the monitor during patient transport within a healthcare facility.

The intended use of measurement parameters for each patient type is shown in table below (Parameter (patient types)): Non-invasive BP--NBP (Adult, Pediatric, Neonatal); SpO2 --Masimo rainbow SET or Philips FAST (Adult, Pediatric, Neonatal); Pulse Rate -- PR -- derived from SpO2 or NBP (Adult, Pediatric, Neonatal); Temperature-Predictive, Temporal (Adult, Pediatric, Neonatal); end tidal CO2--etCO2 (Adult, Pediatric, Neonatal); Respiration Rate: airway respiration--awRR (Adult, Pediatric, Neonatal); Respiration Rate: acoustic respiration--RRa (Adult, Pediatric);

Non-invasive Total Hemoglobin--SpHb (Adult, Pediatric)

Contra-indications: Not for transport outside the healthcare facility. Not for use in home setting.

The subject device EarlyVue VS30 is a platform redesigned from the predicate device Suresign VS4 to provide the measurement of the same physiological parameters. It is a multi-parameter compact, portable monitor, offering several configurations and optional features that are intended to meet the customer's needs. The VS30 is designed with a simple, intuitive user interface for ease of operation. It is used to measure or monitor NBP, SpO2, SpHb, RRa, CO2 and optional temperature primarily in non-acute settings.

The subject VS30 also provides the wireless option. The wireless functions for VS30 are for the monitors to communicate with the hospital EMR system or to communicate with Philips IGS software over the hospital's wireless infrastructure.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: EarlyVue VS30 Vital Signs Monitor

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EarlyVue VS30 are implied by its comparison to the predicate device, Philips SureSigns VS4. The document asserts that the VS30 has the "same fundamental technological characteristics" and that "performance data demonstrates the subject device Early Vue VS30 is as safe and effective as the predicate device for all the measurements." Therefore, the predicate device's specifications serve as the de facto acceptance criteria for each measurement parameter.

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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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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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The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit. either providing an alert or triggering an alarm which stops the cardioplegia pump only. The monitor also measures temperatures of the patient or extracorporeal circuit, counts the time during and between cardiopleqia doses, and tracks the volume of cardioplegia delivered.

The Sarns 8000 Cardioplegia Monitor is only compatible with the Sarns 8000 Modular Perfusion System. The Sarns 8000 Cardioplegia Monitor can display two pressures and three temperatures from attached probes. The pressure has alert and alarm levels which are set by the operator. The Sarns 8000 Cardioplegia Monitor also has a timer for use in tracking the time during and between doses of cardioplegia. With the new added features, it also displays the volume of cardioplegia delivered to the patient. The Sarns 8000 Cardioplegia Monitor communicates with the Sarns 8000 Roller Pump for obtaining volume information and to stop the roller pump (designated for cardioplegia delivery) during a pressure alarm condition if set by the operator to do so. The Sarns 8000 Cardioplegia Monitor also communicates with the Sarns 8000 Data Communications Module for purposes of data acquisition.

The provided text is a 510(k) summary for the Sarns 8000 Cardioplegia Monitor and does not describe acceptance criteria, performance data, or a study that typically involves AI or human interpretation elements. The device is a monitor for extracorporeal line pressure, temperature, time, and cardioplegia volume, and the document focuses on its substantial equivalence to predicate devices and software modifications.

Therefore, many of the requested items (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI, etc.) are not applicable to the information provided in this regulatory submission.

However, based on the nonclinical performance section, we can infer some information that partially addresses your request, specifically point a.

a. A table of acceptance criteria and the reported device performance

Based on the "Nonclinical Performance" and "Conclusions from Nonclinical Tests" sections, the implied acceptance criterion is that the device functions as intended according to its performance specification.

The following points cannot be answered from the provided text as they relate to AI/machine learning studies or clinical trials, which were not part of this device's submission or testing.

b. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable; no "test set" in the context of AI/ML or clinical data is mentioned. The testing was nonclinical and focused on software validation.

c. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable; no expert-established ground truth is mentioned. The "ground truth" for this device would be its engineering specifications and correct functional operation.

d. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable; no adjudication method is mentioned as this was a nonclinical software validation.

e. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable; no MRMC study, human readers, or AI assistance is mentioned.

f. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable; no standalone algorithm performance in the context of AI is mentioned. The device itself is an "algorithm only" device in a sense, as it performs its functions without direct human intervention once parameters are set, but this is not typically what is meant by "standalone performance" in AI contexts.

g. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance would be engineering and software validation against pre-defined functional specifications.

h. The sample size for the training set

• Not applicable; no training set (in the context of AI/ML) is mentioned.

i. How the ground truth for the training set was established

• Not applicable; no training set is mentioned.

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