(90 days)
The intended use of the BEACON Caresystem is to provide
- respiratory mechanics monitoring in adult patients in the Intensive Care Unit (ICU)
- on-demand ventilator-dependent open-loop advice in mechanically ventilated adult patients as prescribed by the clinician
Patients should be hemodynamically stable.
The device is intended for use by properly trained clinicians. BEACON Caresystem is for prescription use, only.
BEACON Caresystem is an Intensive Care Unit (ICU) ventilation assist system. BEACON Caresystem will provide ICU clinicians with on-demand ventilator-dependent open-loop advice for ventilating adult patients.
BEACON Caresystem uses inputs measured by BEACON Caresystem and data inputs from the ventilator and manual data entry by the clinician into a computer program that has been designed to provide advice for changes to the ventilator settings for the individual patient undergoing mechanical ventilation.
BEACON Caresystem is an adjunct to third party legally marketed ICU mechanical ventilators.
BEACON Caresystem consists of the following components:
- BEACON Display Unit
- BEACON Gas Module
- BEACON Power Adaptor
- NONIN XPOD SpO2 Analyzer
BEACON Caresystem utilizes the following cleared accessories:
- BEACON Flow Sensor (Adult) private label version of Metaphor E-Z Flow Sensor, Size Adult [K093080]
- BEACON Water Trap (Adult) [K182075 & K171292]
- NONIN Finger Clip SpO2 sensor NONIN 8000AA1 [K071285]
- NONIN Ear Clip SpO2 sensor- NONIN 8000Q2 [K080255]
- NONIN Forehead Reflectance SpO2 sensor NONIN 8000R [K071285]
The BEACON Display Unit is a standard off-the-shelf tablet touch-screen computer. The BEACON display unit connects through a USB port to the NONIN XPOD SpO2 analyzer for pulse oximetry measurements and serial data ports for connection to the BEACON Gas Module and the connected ICU ventilator. The BEACON Display unit includes the BEACON Caresystem Software. The BEACON Gas Module performs measurement of patient airway flow and inspired and expired fractions of CO2 and O2 in the airway.
As described above, BEACON Caresystem combines the functionalities of a spirometric monitor, respiratory gas monitor, and pulse oximeter. Each of these functions, respectively, is intended for:
- Respiratory mechanics monitoring (i.e. airway flow/volume)
- Measurement of expired and inspired breathing gases (CO2, O2) and respiration rate
- Non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
The BEACON Caresystem Software utilizes the monitored parameters above with data from the connected ICU ventilator and clinician entered values to generate on demand, open-loop advice for changes to the ventilator settings for an adult patient undergoing mechanical ventilation.
The BEACON Caresystem is intended to provide respiratory mechanics monitoring and on-demand ventilator-dependent open-loop advice for mechanically ventilated adult patients in the Intensive Care Unit (ICU).
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in a quantifiable table with specific thresholds (e.g., accuracy > 90%). Instead, it describes a comparative approach where the BEACON Caresystem's performance is deemed "comparable" to a legally marketed predicate device.
| Acceptance Criterion (Inferred from comparisons) | Reported Device Performance (as stated in the document) |
|---|---|
| Device Performance - Advice Generation: | A head-to-head test on a patient simulator showed that the BEACON advice generation is comparable to the predicate device. Three clinical studies concluded that BEACON Caresystem generated advice with high clinical practice agreement. One study showed that BEACON Caresystem responded appropriately to over and under support for spontaneous breathing patients. The fifth study evaluated BEACON advice and active clinicians in patient cases. |
| Device Performance - Gas and Flow Measurements: | Bench test comparisons with predicate and reference devices for End-tidal Carbon Dioxide (EtCO2), Alveolar Ventilation (VA), Respiratory Rate (RR), Oxygen Uptake (VO2), Carbon Dioxide Production (VCO2), and Energy Expenditure (EE) showed that the measurements of BEACON are comparable to the predicate or reference devices in the full ranges specified. |
| Compliance with Standards: | Designed and tested for compliance to IEC 60601-1:2012 Ed. 3.1, IEC 60601-1-2:2014 ed.4, IEC 80601-2-61:2017, AIM Standard 7351731 Rev. 2.00 2017-02-23, IEC 62304 Edition 1.1 2015-06, IEC 62366-1 Edition 1.0 2015-02, and ISTA 3A 2008. |
| Biocompatibility: | Not applicable for new testing, as patient-contacting accessories are FDA-cleared and legally marketed. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that five clinical studies were submitted, and these appear to form the basis of the test set for the advice generation. However, it does not explicitly state the sample size (number of patients or cases) for any of these clinical studies or for the bench tests.
The provenance of the data (country of origin, retrospective or prospective) is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The information provided does not specify the number of experts used to establish ground truth for the clinical studies. For the study evaluating BEACON Caresystem advice and active clinicians, it mentions "active clinicians" but does not detail their number or specific qualifications. For the study on spontaneous breathing patients, it mentions using an "esophageal catheter" as a reference technique, implying a technical measurement rather than expert consensus for that specific ground truth.
4. Adjudication Method for the Test Set
The document does not explicitly describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the clinical studies. For the study evaluating BEACON Caresystem advice and active clinicians, it states it was evaluated "blindly," but further details on adjudication are missing.
5. 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
The provided text does not indicate that a Multi Reader Multi Case (MRMC) comparative effectiveness study was performed to assess how much human readers improve with AI vs. without AI assistance. The clinical studies primarily focus on the agreement and appropriateness of the BEACON Caresystem's advice, not on human reader performance with or without the device. The fifth study did "evaluate blindly the BEACON Caresystem advice and active clinicians in patient cases," but it's not described as an MRMC comparative effectiveness study to measure improvement from AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone evaluation of the algorithm's performance (advice generation and measurement accuracy) appears to have been a significant part of the testing.
- Bench Tests: Gas and flow measurements (EtCO2, VA, RR, VO2, VCO2, EE) were evaluated in "bench test comparisons with predicate and reference devices." This suggests a standalone evaluation of the device's measurement accuracy against established standards without direct human-in-the-loop influence on the measurement results.
- Patient Simulator Test: A "head-to-head test comparing the advice presented by BEACON and the predicate device was performed on a patient simulator." This is a standalone evaluation of the advice generation algorithm.
- Clinical Studies: The clinical studies primarily assessed the advice generated by the BEACON Caresystem ("agreement of BEACON Caresystem advice," "effect of the applied advice," "ability of BEACON Caresystem advice to find appropriate breathing effort levels"), implying an evaluation of the device's output.
7. The Type of Ground Truth Used
The ground truth for different aspects of the device's performance appears to vary:
- Advice Generation: Ground truth appears to be established through:
- Comparison with the predicate device's advice on a patient simulator.
- "Clinical practice agreement" in three clinical studies, suggesting agreement with established medical best practices or expert clinical judgment (though details on how this was established are scarce).
- Reference technique (esophageal catheter) for breathing effort levels in one study.
- Comparison with "active clinicians" in patient cases in the fifth study.
- Gas and Flow Measurements: Ground truth was established by comparison with predicate and reference devices in bench tests.
8. The Sample Size for the Training Set
The provided text does not contain any information about the training set for the BEACON Caresystem software or algorithm. This document focuses on the S510(k) submission, which typically emphasizes testing of the final product rather than describing the development and training phases.
9. How the Ground Truth for the Training Set Was Established
Since no information is provided about the training set (see point 8), there is no information on how its ground truth was established.
§ 868.1850 Monitoring spirometer.
(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).