Search Results

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 pediatic (i.e., infant, child and adolescent) patients, greater than or equal to 5kg (11 1bs).

The FLIGHT 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is sutable 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. 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.

The provided text is a 510(k) summary for the FLIGHT 60 Ventilator, focusing on a modification to its compressor. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance data in narrative form rather than a direct table of acceptance criteria vs. performance. However, it indicates that the device "met the predetermined acceptance criteria" for all tests.

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

The document does not specify a "sample size" in terms of number of patients or clinical cases for a test set. The testing described is primarily non-clinical performance testing of a medical device (ventilator). The "test set" consists of the physical device undergoing various engineering and performance evaluations.

• Sample Size: Not applicable in the context of clinical patient data. The "sample" is presumably one or more units of the revised FLIGHT 60 Ventilator.
• Data Provenance: The data provenance is from laboratory and engineering testing conducted by the manufacturer, Flight Medical Innovations Ltd., as part of the design and verification activities. The country origin is not explicitly stated for the testing itself, but the manufacturer is based in Israel (Petach Tikva). The submission is to the US FDA. This is retrospective in the sense that the testing has already been completed for the submission.

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

This section is not applicable as the described testing is non-clinical performance and engineering validation. "Ground truth" in this context refers to established engineering specifications, performance standards (e.g., IEC, ISO), and comparisons to predicate device measurements, not expert clinical diagnoses. Therefore, there were no clinical experts establishing "ground truth" for the test set.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for clinical studies where expert consensus is needed to establish ground truth from ambiguous cases (e.g., in medical imaging interpretation). Since the described testing is non-clinical performance validation, an adjudication method was not used. The performance was directly measured against predetermined engineering specifications and international standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing for a ventilator, not a study involving human readers interpreting cases.

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

This concept is typically applied to AI/ML devices. The FLIGHT 60 Ventilator is a hardware-based medical device with microprocessor control, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The performance described is the standalone performance of the mechanical ventilator itself, which inherently involves its internal software/firmware control without a "human-in-the-loop" in the sense of an assist/no-assist comparison.

7. The Type of Ground Truth Used

The "ground truth" used for this device validation is based on:

• Established engineering specifications: Predefined performance parameters for the ventilator.
• International standards: Compliance with standards like IEC 60601-1, ISO 80601-2-12, and IEC 60601-1-2.
• Predicate device performance: Comparative measurements against the predicate FLIGHT 60 (K130171) and Trilogy 100 (K083526) to demonstrate substantial equivalence, particularly for waveform characteristics.

8. The Sample Size for the Training Set

Not applicable. The FLIGHT 60 Ventilator is a hardware medical device with embedded software, not a machine learning model that requires a "training set."

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

Not applicable. As a hardware medical device, there is no "training set" or corresponding ground truth establishment process in the context of machine learning.

Ask a specific question about this device