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510(k) Data Aggregation
(267 days)
ARCHEON
EOlife is intended for use with emergency manual resuscitation devices to measure ventilatory flows and display visual guide on the insufflated volume, and ventilation frequency to ensure adequate ventilation of adult cardiopulmonary arrest patient during cardiopulmonary resuscitation (CPR) performed by healthcare professionals.
EOlife is a medical device dedicated to healthcare professionals to help them providing manual ventilation during cardiopulmonary resuscitation (CPR). EOlife is intended to be connected to any standard manual resuscitator for adults including a bag and a mask or endotracheal tube (ET tube) and supraglottic airway (SGA) device and to be used during manual ventilation of an adult cardiopulmonary arrest patient. EOlife is a portable device composed of an electronic control unit including an embedded software, a removable and rechargeable battery pack and of a single use flow sensor: FlowSense. EOlife does not present direct contact with the patient. Only the ventilation air flow is in contact with the internal part of FlowSense (indirect contact with the patient). During manual ventilation, EOlife measures the ventilation parameters (insufflated volumes, tidal volumes, ventilation frequencies, ) and gives real-time feedback to the user about the quality of the ventilation provided to the patient compared to the 2020 AHA (American Heart Association) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 3: Adult Basic and Advanced Life Support. The aim is to help the user ventilate according to the recommended frequencies (10 cycles per minute) and volumes (6-8 ml/kg of ideal body weight).
The provided text describes the EOlife device, a medical device intended to assist healthcare professionals in manual ventilation during cardiopulmonary resuscitation (CPR) by measuring ventilatory flows and displaying visual guides on insufflated volume and ventilation frequency. The document is a 510(k) premarket notification by Archeon Medical to the FDA, asserting substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document includes a "Comparison of Technological Characteristics with Predicate Device" (Table 1) and a "Summary of Performance Testing" (Table 2). The most relevant section for acceptance criteria related to product performance is the "Measuring range and accuracy of ventilation values" and "Measuring range and accuracy of ventilation frequencies" within Table 1.
| Acceptance Criteria (from Subject Device) | Reported Device Performance and Discussion (from Subject Device, Predicate Device, and Discussion columns in Table 1) |
|---|---|
| Insufflated Volume (Vi): Operating range 50 to 2000 ml | Vi: Operating range 50 to 2000 ml |
| RMSE: 15.7 ml | |
| Tidal Volume (Vt): Operating range 0 to 2000 ml | Vt: Operating range 0 to 2000 ml |
| RMSE: 40 ml | |
| Ventilation Frequency: 1 to 60 bpm, ± 1 bpm | Ventilation Frequency: 1 to 60 bpm, ± 1 bpm |
| Real time emergency feedback: Based on 2020 AHA Guidelines | Comparison to Predicate: Both devices (EOlife and L770-CPR Resuscitation Timer) provide real-time feedback for manual ventilation quality during CPR. The predicate device uses 2005 AHA Guidelines, while EOlife uses 2020 AHA Guidelines. The discussion states this is "Same" because "Both devices were based on the current relevant AHA guideline in force." This implies that adhering to the most current guidelines is an acceptable performance characteristic. |
| Mechanical design and compatibility (with environment and resuscitator) | Bench Testing Summary: Verification of the mechanical design and compatibility of the device with its environment and with the manual resuscitator was performed. Comparison between features (mechanical design, assembly with patient interface and manual resuscitator, ventilation setting) and predicate device was done to demonstrate substantial equivalence. |
| Software functionality, safety, and effectiveness | Software Testing Summary: IEC 62304 testing met requirement of the standard. Software testing included design, development, verification, validation, and traceability. Verification and validation demonstrated that the software functions correctly as designed and operates the device according to device design specifications and requirements. |
| Usability/Human Factors | Usability Assessment Summary: Usability assessment was completed including critical tasks identification through use-based risk analysis, rounds of formative and summative testing according to IEC 62366-1 and FDA guidance. The study demonstrated that users were able to successfully and safely use the device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "The subject EOlife did not require clinical studies to support substantial equivalence." Instead, it relies on non-clinical (bench) testing, usability testing, and comparison to a predicate device.
- Test Set Description: The "test set" in this context refers primarily to the testing conducted on the physical device and its software, rather than a dataset of patient cases.
- Sample Size:
- For the performance metrics (Vi, Vt, Freq), the specific number of tests or samples used to derive the RMSE values is not provided.
- For biocompatibility, electrical safety, EMC, battery, power supply, mechanical, and software testing, the sample size is also not explicitly stated. These types of tests typically involve a limited number of devices to demonstrate compliance with standards.
- For usability testing, "rounds of formative and summative testing" were performed, but the number of participants or test scenarios is not specified.
- Data Provenance: The testing was related to the device itself (hardware, software). No patient data is mentioned as being used for testing. The manufacturer, Archeon Medical, is based in Besançon, France. Therefore, the testing would presumably have been conducted there or by affiliated labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided as the submission focuses on non-clinical testing and comparison to a predicate device, not on diagnostic performance against human expert-established ground truth on a patient dataset. The "ground truth" for the device's measurements (volume, frequency) would be established by calibrated measurement equipment used in the bench testing.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no human expert-based ground truth or adjudication process described for clinical effectiveness. The assessment is against technical specifications and established standards through bench testing.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "The subject EOlife did not require clinical studies to support substantial equivalence." The device is positioned as an "adjunct tool" providing real-time feedback, not as an AI diagnostic tool that human readers would interpret. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The performance testing (bench testing) described in Table 2, specifically the "Accuracy assessment of the values measured and displayed by EOlife," can be considered a form of standalone performance assessment of the device's measurement capabilities. The software within the device operates autonomously to measure and display parameters ("algorithm only"). However, this is for measurement accuracy, not for a diagnostic or interpretive task that would typically be associated with "standalone AI performance" in imaging or other clinical decision support contexts. The device's primary function is to provide real-time guidance to a human user, making it inherently "human-in-the-loop" in its intended use.
7. The Type of Ground Truth Used:
- For the measurement accuracy of volume and frequency values during bench testing, the ground truth would be established by precision laboratory instruments and simulated ventilation profiles (e.g., using a test lung and a ventilator simulator with known, calibrated outputs).
- For biocompatibility, electrical safety, EMC, mechanical, and software validation, the ground truth is compliance with international consensus standards (e.g., ISO, IEC, UN).
- For usability, the ground truth is the successful and safe completion of critical tasks by users as assessed in human factors testing.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The EOlife device is described as having "an embedded software that contains algorithms," but the document does not indicate that these algorithms (for measuring ventilatory flows and providing guidance) were developed using machine learning or required a "training set" of data in the typical sense. It appears to be based on programmed logic and physics models rather than statistical learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided for the same reasons as point 8.
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