Search Results

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.

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

The document does not explicitly state the sample sizes (number of patients, number of measurements) used for performance testing (e.g., NBP accuracy, SpO2 accuracy). It generally refers to "verification and validation" and "performance data."

For the SpO2 and SpHb measurements using Masimo technology, the document references the Masimo RRa respiration rate K110028 and the Oridion MicroMediCO2 module K123690. The accuracy claims for these integrated modules would presumably be based on studies performed during their original clearance, but specific details about those test sets are not in this document.

The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth for the test set. For physiological measurements like NBP, SpO2, and temperature, ground truth is typically established using reference methods (e.g., arterial catheter for NBP, co-oximetry for SpO2, calibrated thermometer for temperature) rather than expert consensus on interpretive tasks.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set, as this is typically applicable to subjective interpretations by multiple experts (e.g., radiology reads), not direct physiological measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable to this submission. The EarlyVue VS30 is a vital signs monitor that directly measures physiological parameters. It does not involve "human readers" interpreting medical images or other data with or without "AI assistance." The device's function is to provide direct measurements, not to aid in human diagnostic interpretations.

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

Yes, the primary function of the EarlyVue VS30 is as a standalone device that performs physiological measurements without a human-in-the-loop for the measurement process itself. The "performance data" referred to throughout the document would be standalone performance of the device's measurement functions.

7. The Type of Ground Truth Used

The ground truth for the physiological measurements (NBP, SpO2, Temperature, CO2) would typically be established using:

• Reference Devices/Methods:
  • NBP: Invasive arterial blood pressure measurements or comparison to a validated reference sphygmomanometer.
  • SpO2: Co-oximetry for arterial oxygen saturation.
  • Temperature: Calibrated reference thermometers (e.g., mercury-in-glass, highly accurate electronic thermometers).
  • CO2: Calibrated gas analyzers.

The document states that the technologies used are "identical" to the predicate device, which in turn relied on established measurement technologies (Philips picoNBP, Masimo Rainbow SET, Oridion MicroMediCO2 module). These underlying technologies would have their own validation against established ground truth methods.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This is because the EarlyVue VS30 is not described as an AI/ML-based device that learns from a training set in the typical sense (e.g., for image classification or prediction). Its functions are based on established physiological measurement principles and algorithms. The software was "recoded" compared to the predicate, implying engineering-based development and verification, rather than a data-driven training process.

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

Since no explicit training set is mentioned for an AI/ML context, this question is not directly applicable. The device's "ground truth" refers to its accuracy against established medical standards for physiological measurements. The document outlines a comprehensive verification and validation process (software, hardware, environmental, reliability, safety, performance, applicable consensus standards: IEC 60601 series, ISO 80601 series, etc.) to ensure the device performs as intended and is as safe and effective as the predicate.

Ask a specific question about this device