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The Ventoux is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the Ventoux is applicable for adult and pediatric (i.e., infant, child and adolescent) patients who weigh at least 5 kg (11 lbs).

The Ventoux 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 environments.

The Ventoux Ventilator is an electrically powered, microprocessor-controlled multi-parameter ventilator, which can be: Time, Pressure, Flow or Volume triggered; Volume or Pressure controlled; Time or Flow cycled.

Manual inflation is allowed, and the Ventoux supports the emergency intake of ambient air which permits the patient to pull ambient air into the breathing circuit in the event of a complete loss of air/gas supply.

Volume triggered is based on Inspiratory trig response time ≤100 ms from pressure drop/flow rise to PEEP level.

Ventilation is possible in both Invasive and Noninvasive settings.

The system can be expanded to include additional parameter monitoring to allow for Sp02, etC02 and Cuff Pressure Control.

The Ventoux can be powered by external power (100 – 240 VAC, 50-60 HZ or 10 – 30 VDC) and/or by its two swappable internal Li Ion rechargeable batteries, which provide full operating power the to the ventilator for a minimal operating time of 6 hours when operating on standard ventilation parameters.

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.

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 FDA 510(k) summary (K223120 for the Ventoux Ventilator) does not contain information about an AI/ML powered device. The document describes a traditional medical device (a continuous ventilator) and its comparison to predicate devices based on established engineering and performance standards.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, human reader improvement with AI assistance, or ground truth establishment for an AI/ML model. The 510(k) summary specifically states:

"No clinical testing was conducted or required in support of this premarket notification." and "The software design and validation process, together with the bench testing of the device, demonstrated Ventoux Ventilator performs as intended."

This indicates that the device's performance was validated through bench testing and compliance with recognized standards, not through studies involving AI/ML performance metrics, expert consensus, or multi-reader studies as would be typical for AI-powered diagnostic aids.

The document focuses on:

• Technological Characteristics Comparison: Showing the Ventoux has similar features and functionalities to predicate devices.
• Performance Data: Demonstrating compliance with various IEC and ISO standards related to electrical safety, EMC, basic safety and essential performance of ventilators, alarm systems, gas monitors, pulse oximeters, environmental testing (shock, rough handling, vibration), altitude, internal temperature, and battery validation.
• Software Design and Validation: Stating that this was performed and contributed to demonstration of intended performance.
• Bench Testing: Stating that bench testing was conducted to verify compliance with predefined specifications and internal procedures.
• Biocompatibility: Assessment of gas pathways.

To answer your request, an AI/ML-specific device submission would be needed, which would detail metrics like sensitivity, specificity, AUC, and studies with expert readers. This document does not provide such information.

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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.

• IEC 60601-1: General Requirements for Basic Safety and Essential Performance (2005), including US national deviations.
• ISO 80601-2-12: Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators (2011).
• IEC 60601-1-2: Electromagnetic Compatibility - Requirements and Tests (2007).
  • EMC Specifics: ESD contact discharge (8 kV), air discharge (15 kV), radiated immunity (30 V/m), magnetic field immunity (30 A/m). |
    | Environmental Performance | Flight 60 was subjected to environmental tests. |
    | Volatile Organic Compounds (VOC) | Tested by EPA test TO-15. |
    | Particulate Matter (PM 2.5) | Tested by EPA's PM 2.5. |
    | Waveform Performance (Non-Clinical) | Side-by-side waveform performance test comparing Flight 60 (revised) to Trilogy 100 (K083526) and Flight 60 (K130171). Characteristics tested included flow, pressure, and volume waveforms, ventilation control parameter accuracy, and patient trigger reliability and synchrony. |
    | Overall Compliance | "All tests confirmed the product met the predetermined acceptance criteria." "The comparison of the recorded waveforms supports the claim that FLIGHT 60 is substantially equivalent to the predicate devices." |

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.

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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.

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.

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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

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.

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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."

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.

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