(119 days)
The FLIGHT 60 Ventilator is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the FLIGHT 60 is applicable for adult and pediatric (i.e., infant, child and adolescent) patients, greater than or equal to 5kg (11 lbs).
The FLIGHT 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
The FLIGHT 60 Ventilator is an electrically powered, microprocessor controlled ventilator with the following types of ventilatory support: A/CMV Volume or Pressure Control, SIMV Volume or Pressure Control, Pressure Support & SPONT mode with Pressure Support. It can be pressure or time triggered; volume or pressure limited; time, pressure or flow cycled. Manual inflation is possible, and an emergency intake valve allows the patient to pull ambient air into the breathing circuit in the event of a complete loss of supply gas pressure.
The FLIGHT 60 may be powered by external power (100 - 240 VACS or 12 - 15 VDC) or by its two internal Li Ion rechargeable batteries, which power the ventilator for up to 12 hours when fully charged.
The electrical system is comprised of three primary boards: the Main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU, the Power board, which holds the power subsystems, and internal communication functions, and the Communication board, which holds internal communication and external communication connectors.
The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides a built in PEEP.
A comprehensive alarm system is built-in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.
Here's an analysis of the provided text regarding the FLIGHT 60 Ventilator, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary for a medical device (a ventilator). Unlike AI/ML-driven devices, traditional medical devices like ventilators do not typically have "acceptance criteria" in the same way an AI algorithm has performance metrics (e.g., sensitivity, specificity, AUC). Instead, they meet performance specifications and recognized standards to ensure safety and effectiveness. The "study" here refers to the verification and validation (V&V) testing.
Therefore, many of the requested categories (sample size for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable in the context of a ventilator's regulatory submission. This information is primarily relevant for AI/ML devices that make diagnostic or prognostic predictions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Specifications/Standards) | Reported Device Performance |
|---|---|
| Applicable Device Specification Requirements for Performance Testing (as identified in FDA reviewer guidance for ventilators) | Met all applicable device specification requirements. |
| Compliance with Recognized Standards for safe use of the device in its intended environment. | Verification of compliance with recognized standards has been made. |
| Substantial Equivalence to Predicate Devices (Flight 60, K111683; Vela, K032451; Trilogy 100, K083526) without raising new safety or effectiveness concerns. | Demonstrated substantial equivalence without raising any new safety and/or effectiveness concerns. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as this is a physical medical device (ventilator), not a diagnostic algorithm. The "test set" for a ventilator would involve rigorous engineering and safety testing under various simulated and real-world conditions, rather than a dataset of patient information. The document refers to "performance testing" and "verification of compliance," which implies testing of the physical device's functionality and adherence to safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. The "ground truth" for a ventilator's performance is objective physical measurements and safety standards (e.g., gas flow rates, pressure delivery, alarm functionality, battery life, power consumption). This does not involve expert consensus on medical images or diagnoses. Experts (e.g., engineers, clinicians) would be involved in designing the specifications and evaluating test results, but not in establishing a "ground truth" that is then compared against an algorithm's output.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert interpretations, typically for establishing ground truth in diagnostic studies. For a ventilator, performance is objectively measured against specifications and standards, not subject to subjective adjudication in this way.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
This information is not applicable. MRMC studies are designed to assess the impact of an AI system on human reader performance, usually in image interpretation. This ventilator is a life-support device, not a diagnostic imaging aid. The "comparison" mentioned in the document is between the new FLIGHT 60 and its predicate devices to demonstrate substantial equivalence, not an assessment of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The FLIGHT 60 is a ventilator, a standalone medical device that performs a mechanical function. It's not an algorithm that makes diagnostic predictions. Its performance is its own operation, and it's designed to be used with human oversight, but not as an "AI-only" component.
7. The Type of Ground Truth Used
The "ground truth" for a ventilator's performance is typically defined by:
- Engineering specifications: Precise measurements of gas delivery, pressure, oxygen concentration, flow rates, alarm thresholds, battery duration, power consumption, etc.
- Recognized national and international standards: Adherence to standards like ISO 80601-2-12 for critical care ventilators, or specific electrical safety standards.
- Biocompatibility testing: Ensuring materials are safe for patient contact.
- Electromagnetic compatibility (EMC) testing: Ensuring it doesn't interfere with or get interfered by other devices.
- Environmental testing: Performance under varying temperatures, humidity, and vibration.
It is not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be.
8. The Sample Size for the Training Set
This information is not applicable. Ventilators do not have "training sets" in the context of machine learning. Their functionality is programmed and engineered, not "learned" from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no "training set" for a ventilator in the AI/ML sense, there's no ground truth to establish for it. The ventilator's operational parameters are based on scientific and medical principles, engineering design, and regulatory standards.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).