(138 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 10kg (22 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.
This document is a 510(k) summary for the Flight 60 Ventilator, focusing on its substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a specific algorithm or AI is not present.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document states: "The Flight 60 Ventilator meets all applicable device specification requirements for performance testing as identified in the FDA reviewer guidance for ventilators. Verification of compliance with recognized standards has been made to support safe use of the device for its intended use and in its intended environment." It also mentions a usability/human factors study.
While specific numerical acceptance criteria or performance metrics are not given, the overall acceptance criterion can be inferred as "meeting all applicable device specification requirements and recognized standards."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Meets applicable device specifications for performance testing | "The Flight 60 Ventilator meets all applicable device specification requirements for performance testing as identified in the FDA reviewer guidance for ventilators." |
| Complies with recognized standards for safe use | "Verification of compliance with recognized standards has been made to support safe use of the device for its intended use and in its intended environment." |
| User interface is simple and easy to use | "The results of the study demonstrated that the ventilator's user interface is simple and easy to use for the potential users." |
| Substantial equivalence to predicate devices | "comparison between the performance of the revised Flight 60 Ventilator (subject of this submission) with its predicate devices... demonstrated that the Flight 60 Ventilator is substantially equivalent to it predicate devices without raising any new safety and/or effectiveness concerns." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "usability/human factors study" and refers to "users" being requested to use the ventilator.
- Sample size: Not specified.
- Data provenance: Not specified, but the applicant is "Flight Medical Innovations Ltd. 13 Hamelacha Street North Industrial Park Lod 71520, Israel," so presumably, the study was conducted there or relevant to their market. The study seems prospective in nature ("First users were requested to use the ventilator...").
3. 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)
This information is not provided because the "study" mentioned is a usability/human factors study, not a clinical study evaluating diagnostic accuracy or a similar measure that would require expert-established ground truth. The "ground truth" for a usability study would be user feedback and observed interactions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was a usability study focused on user experience, not a clinical trial with adjudicated outcomes from experts.
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
Not applicable. The Flight 60 Ventilator is a hardware device, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a hardware medical device (ventilator).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the usability/human factors study, the "ground truth" would be the subjective and objective feedback from the users regarding ease of use, and potentially observed performance during simulated tasks. For the overall device performance, the "ground truth" is compliance with recognized standards and device specifications, which would be verified through engineering and performance testing. There's no clinical "ground truth" in the sense of pathology or outcomes data presented here for efficacy.
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI model.
9. How the ground truth for the training set was established
Not applicable, as this is a hardware device, not an AI model requiring a training set with established ground truth.
§ 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).