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Care Orchestrator Essence is intended for use by healthcare professionals (e.g., Physicians, Durable Medical Equipment providers) to gather, store, manage, and view compliance data for patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. The software also includes the ability to create new or updated prescriptions and/or performance settings, store them, and transmit them to compatible Respironics' non-life supporting therapy devices and Respironics Trilogy ventilator. Data and prescription settings are transferred between Care Orchestrator Essence and compatible devices via removable media. Care Orchestrator Essence is intended to be used in hospital, institutional, provider, and home care settings by healthcare representatives.

The software does not perform automatic scoring or diagnosis. The data it provides are only one of several elements to consider when making decisions about patient therapy.

Care Orchestrator Essence software is a desktop solution that allows healthcare representatives (e.g., physicians, clinicians, durable medical equipment providers) involved in a patient's therapy lifecycle the ability to manage patients and referrals; control access to patient information; view and interact with therapy and prescription data from Respironics devices; enhance the patient compliance management workflow; and gain efficiencies in the overall patient therapy workflow.

Care Orchestrator Essence supports patient data management and prescription updates for sleep therapy devices (BZD, MNS, MNT) and Trilogy respiratory devices (CBK, NOU) through an SD card.

I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) premarket notification for a medical device called "Care Orchestrator Essence," which is a software for managing patient compliance data and therapy settings for compatible Respironics devices.

While it mentions software verification and validation testing and non-clinical tests were conducted, it does not provide details on:

1. A table of acceptance criteria and reported device performance. It broadly states that "all product requirements have been met with acceptable test results," but no specific criteria or performance metrics are listed.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study. The device does not perform automatic scoring or diagnosis, so this type of study would not be applicable.
6. Standalone (algorithm-only) performance. The device is intended to be used by healthcare professionals.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document emphasizes that clinical tests were not required and that the effectiveness was demonstrated through non-clinical testing and comparison to predicate devices. It focuses on the functional similarities and differences between the new device and previously cleared predicate devices rather than providing detailed performance metrics from a study that fits the criteria of your request (e.g., studies involving ROC curves, sensitivity, specificity, etc., which are common for diagnostic or AI-driven systems).

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The Care Cycle Connect software application is intended for use with Trilogy Series ventilators by both caregivers and clinicians. The application pairs with the Trilogy device via a Bluetooth connection. The application provides the caregiver remote patient monitoring, and alarm surveillance. Alarm surveillance consists of both an audible tone and a visible alert if an alarm condition exists. The application provides the clinician with the ability to view, collect and store patient ventilator usage data. Care Cycle Connect also provides educational information on ventilator use to both caregivers and clinicians. It is intended to be used in the home, and hospital/ institutional settings. The Care Cycle connect application is intended to supplement and not replace any part of the current device monitoring procedures.

The Care Cycle Connect application is an accessory to a continuous ventilator (product code MOD). Care Cycle Connect is intended for use with the Trilogy Series of Ventilators cleared by the US FDA under K083526, K093416, K093905, and K111610. Care Cycle Connect (CCC) is a mobile software application designed to provide features and functions related to respiratory care in the home, hospital and institutional healthcare settings. The application provides the caregiver remote patient monitoring and alarm surveillance. The CCC application has been designed with two users in mind, the caregiver and the clinician. The functionality of the application is tailored to the different needs of these users and is configured when the application is installed. At the initial start-up of the application, users are asked to choose either careqiver (for patients and their in-home caregivers) or clinician mode. Functionality is based on the configuration selected. Once this choice is made, users cannot switch back and forth between the two configurations. The primary users expected to interact with Care Cycle Connect in the context of patient care in the home (the main use scenario) are caregivers and respiratory therapists (clinicians). CCC may also be used if the patient is in a hospital or institutional environment (sub-acute care facility). Caregivers are not expected to use CCC in a hospital or institutional setting. Care Cycle Connect provides constant feedback to the caregiver while the app is connected to the ventilator. This feedback is displayed via the Manometer Display feature within the application. This constant display provides data on the patient's use of the ventilator, ensuring that the ventilator is providing therapy. Care Cycle Connect will also provide educational information on the use of the ventilator to the caregiver or clinician, independent of being connected to the ventilator. The respiratory therapist will use the app when connected to a patient ventilator while on a home visit to gather ventilator data. It provides an interface for keeping patient information. When the app is not connected to the patient ventilator, the clinician can review stored data, such as appointments, journal, and vent check records. In the hospital or institutional environment. CCC may be used by clinicians to schedule and perform vent checks, which would be completed in the patient's room. Care Cycle Connect is an application that can be loaded onto an Apple device (iPad) that uses iOS 8.0 or more recent. The application relies on a Bluetooth Class 1 radio connection to a Trilogy ventilator. With the exception of low level communication protocol information (i.e., handshake connection), the Trilogy device does not accept any data, commands, or controls from the CCC Application. The Trilogy device functionality is not changed in any manner by connecting to the CCC Application. The Trilogy device simply sends information to the CCC Application on a periodic basis.

The provided text describes the acceptance criteria and study information for the "Care Cycle Connect" software application.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the test set used in "Software Verification and Validation Testing" or "Usability Testing." It mentions "complete system level testing" and "usability testing was completed," implying a sufficient set of tests were performed.

• Data Provenance: Not explicitly stated as retrospective or prospective patient data. The testing appears to be primarily laboratory/bench testing and simulated use, as it focuses on software verification, validation, and usability with the device itself, rather than clinical patient outcomes. The origin is implicitly related to the manufacturer's testing facilities (Respironics Inc., USA).

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The ground truth for the testing described seems to be based on compliance with international standards (IEC, ISO) and the device's functional design specifications, rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set. The testing described focuses on discrete pass/fail criteria against engineering requirements and established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Clinical tests were not required to demonstrate the substantial equivalence of Care Cycle Connect. Product functionality has been adequately assessed by non-clinical tests." Therefore, an MRMC comparative effectiveness study was not performed.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone performance assessment was effectively done. The "Software Verification and Validation Testing" and "Non-Clinical Tests" describe the evaluation of the Care Cycle Connect application's functionality, adherence to software life cycle processes, alarm system compliance, and usability independent of a clinical human-in-the-loop study. These tests evaluate the algorithm's (software's) performance against its design requirements and relevant standards.

7. Type of Ground Truth Used

The ground truth used for the testing of Care Cycle Connect appears to be:

• Compliance with International Standards: e.g., IEC 62304, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 62366, ISO 14971.
• Product Requirements/Design Specifications: The software was tested against "product requirements" and various listed functionalities (device pairing, login, information display, alarm signals, etc.).
• Guidance Documents: Adherence to FDA guidance documents (e.g., for software, human factors, mobile medical apps, cybersecurity, wireless technology, home use devices).

Essentially, the "ground truth" is a combination of regulatory compliance, engineering specifications, and validated functional behavior.

8. Sample size for the Training Set

Not applicable. The document describes the verification and validation of a software application for remote monitoring and data display for a medical device. It does not mention any machine learning or AI components that would require a dedicated "training set." The software appears to be rule-based or deterministic, rather than data-driven in a way that requires a training set.

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

Not applicable, as there is no mention of a training set for machine learning/AI.

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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 iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities:

• Assist/Control and SIMV with either Volume, Pressure Regulated Volume . Control (PRVC)
• CPAP with Pressure Support and CPAP / Pressure Support Volume Guaranteed (VG) ●
• Adaptive Bi-Level for either NIV or invasive ventilation and Adaptive Bi-Level Volume ● Guaranteed [VG]

The iVent101 ventilator is suitable for use in institution, home and portable settings

The iVent101 is a compact, portable, microprocessor-controlled ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. Internal flow and pressure are read through low/pressure sensors. Clinical data [Tidal Volume, Rate, PIP, FiO2, Peak Flow, Inspiratory Time, I:E Minute Volume) are presented on machine screen. All the operator actions are performed on the LCD touch-screen on the front panel, allowing rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes. The iVent101 can use external AC or DC power supply and contains an integrated battery. The iVent101 is equipped with two configurations, which differs in the patient circuit type that connects to the machine. One configuration is to be used with a standard one limb patient circuit, and the second configuration is to be used with a standard dual limb patient circuit. The two configurations are incorporating the same infrastructure and can be easily replaced by the user.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the iVent101 portable ventilator, which focuses on demonstrating substantial equivalence to a predicate device. It describes the device, its intended use, and the types of non-clinical tests performed (e.g., risk analysis, software validation, performance testing). Crucially, the document explicitly states:

"The subject of this premarket submission, the iVent101, did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods, as no such study was conducted or reported in this submission.

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