(439 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: ACMV Volume, Pressure or PRVC, SIMV Volume, Pressure or PRVC, PSV/SPONT mode with Pressure Support and Volume Guarantee, Bi-Level (APRV). It can be pressure, flow 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 subsystem 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 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 acceptance criteria and study information for the FLIGHT 60 Ventilator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on establishing substantial equivalence to predicate devices and adherence to medical device standards. It does not present specific quantitative acceptance criteria alongside corresponding performance metrics in a direct table format for the FLIGHT 60 Ventilator itself. Instead, it makes a general statement about meeting "applicable device specification" and compliance with recognized standards.
However, we can infer the "acceptance criteria" through the mentioned standards and the general statement about meeting design verification criteria. The "reported device performance" is essentially the statement of compliance.
| Acceptance Criteria (Inferred from Standards & General Statements) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1:1998 (+A1:1991+A2:1995) (Medical electrical equipment - Part 1: General requirements for safety and essential performance) | Device is compliant with this standard. |
| Compliance with IEC 60601-1-2:2007 (Electromagnetic compatibility. Requirements and tests) | Device is compliant with this standard. |
| Compliance with IEC 60601-1-8:2006 (General requirements, tests and guidance for alarm systems in medical equipment and medical electrical systems) | Device is compliant with this standard. |
| Compliance with IEC 60601-2-12:2001 (Particular requirement for the safety of lung ventilators -- Critical care ventilators) | Device is compliant with this standard. |
| Compliance with ASTM F 1246-91 (Standard Specification for Electrically Powered Home Care Ventilators Part 1-Positive-Pressure Ventilators and Ventilator Circuits) | Device is compliant with this standard. |
| Meeting all applicable device specifications (general statement) | Device met required design verification criteria. |
| Acceptable performance when used in accordance with its labeling | Device has acceptable performance when used as intended. |
| Performance parameters comparable to referenced predicate devices | Performance parameters are comparable to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance data. The "Performance Data" section merely states: "FLIGHT 60 Ventilator meets all applicable device specification... Verification of compliance with recognized standard has been made to support use of the device for its intended use and in its intended environment." This suggests testing was conducted, but the specifics of the test set are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for a test set. This type of evaluation is common for diagnostic/AI devices, but for a ventilator, performance is typically assessed against engineering specifications and international standards, often through bench testing and simulated use, rather than requiring expert interpretation of results.
4. Adjudication Method for the Test Set
Since the document does not describe a study involving a "test set" in the context of expert review or clinical outcomes requiring adjudication, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, the document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is more relevant for diagnostic imaging devices where human readers interpret medical images, and the performance of AI-assisted reading is compared to unassisted reading. The FLIGHT 60 Ventilator is a treatment device, not a diagnostic one in that context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone performance" typically applies to AI algorithms that provide a diagnostic or predictive output without human intervention. The FLIGHT 60 Ventilator is a physical medical device. Its "performance" is inherently standalone in that it functions independently according to its design and specifications. There's no AI algorithm in the sense of a diagnostic one being evaluated for standalone performance here. The document states it is "microprocessor controlled" but doesn't imply an AI component requiring this type of assessment.
7. The Type of Ground Truth Used
For medical devices like ventilators, the "ground truth" for performance evaluation is typically established through:
- Engineering specifications and design requirements: The device's output (e.g., delivered volume, pressure, flow) is measured and compared against its programmed settings and acceptable tolerances.
- International standards conformance: Performance is assessed against the requirements of relevant ISO and IEC standards (as listed), which define acceptable ranges and behaviors for medical electrical equipment and specific device types.
- Simulated physiological models: Ventilator performance can be tested using lung simulators that mimic various patient conditions.
The document explicitly states that "Verification and validation activities were conducted to establish the performance characteristics of the FLIGHT 60 Ventilator" and that "All testing demonstrated that the FLIGHT 60 Ventilator met required design verification criteria and has acceptable performance when used in accordance with its labeling." This indicates that the ground truth was based on pre-defined engineering standards and specified performance parameters.
8. The Sample Size for the Training Set
The document does not mention a "training set." This term is specific to the development and evaluation of machine learning or artificial intelligence algorithms. The FLIGHT 60 Ventilator is a microprocessor-controlled device, but the context provided does not indicate it uses a machine learning model that would require a distinct training set for its core functionality.
9. How the Ground Truth for the Training Set Was Established
As no "training set" for a machine learning algorithm is discussed, there is no information on how its ground truth might have been established.
§ 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).