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The INOmax DS delivery system delivers INOmax® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

The INOmax DSIR uses a "dual-channel" design to ensure the safe delivery of INOmax. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm.

The provided document describes the INOmax DSIR, a nitric oxide delivery system, and its compatibility with additional respiratory care devices. The submission focuses on non-clinical testing to demonstrate substantial equivalence, rather than a study involving clinical outcomes or diagnostic accuracy. Therefore, information related to observer performance studies (e.g., MRMC studies, standalone performance), ground truth establishment for diagnostic tasks, expert qualifications, and adjudication methods is not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical testing involving the INOmax DSIR and three specific respiratory care devices:

• (K102775) Hamilton C2
• (K070513) Hamilton G5
• (K100011) Fisher & Paykel Healthcare Bubble CPAP System

The testing involved using six INOmax DSIR settings: [0 (baseline), 1, 5, 20, 40] ppm (the sixth value is cut off but implied to be another concentration in ppm). The document states, "The three respiratory care devices were set up and calibrated according to the manufacturer's recommendations, and tested using the settings established for each respiratory care device test." This suggests a systematic testing approach across different settings for each device. However, a specific numerical "sample size" in terms of number of patient cases or repeated measurements for statistical analysis is not detailed in the provided text.

The data provenance is prospective non-clinical testing conducted by INO Therapeutics/Ikaria, likely at their facilities, to evaluate compatibility and performance. There is no indication of country of origin of patient data as no patient data was used.

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

Not applicable. This was a non-clinical device compatibility and performance study, not a diagnostic accuracy study requiring expert-established ground truth. The "ground truth" was the expected performance according to published specifications and manufacturer recommendations for the devices.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical device compatibility and performance study, not a diagnostic accuracy study requiring adjudication of expert interpretations.

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. No MRMC study was conducted, as this submission concerns the hardware and software performance of a nitric oxide delivery system and its compatibility with other respiratory devices, not a diagnostic algorithm involving human readers or AI.

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

Not applicable. The INOmax DSIR is a medical device for delivering and monitoring nitric oxide, not a standalone diagnostic algorithm. Its performance was tested as a standalone system and in conjunction with other respiratory care devices.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical testing was based on:

• Manufacturer's specifications: The INOmax DSIR was expected to "perform within published specifications."
• Manufacturer's recommendations: The respiratory care devices were set up and calibrated "according to the manufacturer's recommendations."
• Expected compatibility: The overall aim was to conclude that the INOmax DSIR and the three respiratory care devices are compatible.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware and software system for medical gas delivery and monitoring, not a machine learning model that requires a training set.

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

Not applicable, as there was no training set.

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The HAMILTON-TC1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics.

Intended areas of use:

• In the intensive care ward or in the recovery room.
• For emergency medical care or primary care.
• During transport within and outside the hospital.
• During transfer by rescue vehicles, jet or helicopter.

The HAMILTON-TC1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-TC1 is designed for adults and pediatrics requiring invasive or noninvasive ventilation support. Due to its compact design, a fully-loaded weight of only 6.5 kg (14.3 lbs), a twin-battery supply, and a built-in turbine; the HAMILTON-TC1 can accompany a ventilated patient everywhere within the hospital or outside the hospital when transport is needed. The HAMILTON-TC1 can run using AC or DC power. It does not need compressed air or O2 to drive the pneumatics, which reduces the weight load in the aircraft needed to operate the ventilator.

Since the HAMILTON-TC1 has been tested and evaluated for flight and high-altitude environments, it can be also used during patient transfer by emergency rescue vehicles, fixedwing aircraft, or helicopter. This makes the HAMILTON-TC1 especially relevant for Aeromedical Evacuations and Medevac operations.

The HAMILTON-TC1 ventilator uses the same graphical user interface (GUI) used by the HAMILTON-C2, featuring a touchscreen "Ventilation Cockpit"; this provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-TC1 includes the ASV ventilation-mode which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.

The HAMILTON-TC1's microprocessor system controls gas delivery and monitors the patient. The qas delivery and monitoring functions are cross-checked by an alarm controller. This crosschecking helps prevent simultaneous failure of these two main functions and minimizes the possible hazards of software failure.

The HAMILTON-TC1 is intended as a transport ventilator, based on the existing HAMILTON-C2, with minor adaptations to make the HAMILTON-TC1 capable of being used in high-altitude flight environments. The HAMILTON-TC1's changes include the following:

• 1. The HAMILTON-TC1 software is identical to the HAMILTON-C2's software, except that some of the options are not available with the HAMILTON-TC1, (e.g. Neonatal Ventilation & nCPAP-PS). Other features like Trends & Loops, NIV, NIV-ST, APRV, and DuoPAP are standard with the C2, but are only optional with the HAMILTON-TC1. The software is also different since the HAMILTON-TC1 includes a DC-power inlet.
• 2. The HAMILTON-TC1 has increased immunity from EMI, including >30 V/m. It also has extra safety features for the EMD, ESD, and RFI environments found on aircraft.
• 3. The unit is contained within an impact resistant case which protects the controls from damage and inadvertent manipulation. The enclosure for the HAMILTON-TC1 has been ruqgedized to withstand shock, vibrations, water ingress, and drops from >1 meter heights.
• 4. The HAMILTON-TC1 was tested for use in fixed and rotary-wing aircraft. Because mechanical ventilation can be challenging during air-medical transport, particularly due to the impact of changing barometric pressure with different altitude levels, the HAMILTON-TC1 automatically compensates for altitude changes. Adjusting provided- and measured-patient volumes accordingly, thereby eliminating the need for manual calculation and reducing the risk of error. This feature is similar to the Oxylog 3000.
• 5. The HAMILTON-TC1 has a "lock-button" which prevents an inadvertent change of settings. If screen lock is active, the following items are inactive: Touchscreen, Power/Standby switch, Print-screen key, Press-and-tum knob. Active are Alarm Silence, Manual Breath, O2 enrichment, Nebulizer. To switch off power, the user must press the On/Off button for > 3 s.

The HAMILTON-TC1 is a continuous ventilator intended to provide positive pressure ventilatory support to adults and pediatrics in various medical settings, including intensive care, emergency care, and during transport. The device's substantial equivalence to predicate devices (HAMILTON-C2 and DRAEGER Oxylog 3000) was established through non-clinical performance testing and compliance with recognized standards.

Here's a breakdown of the acceptance criteria and study aspects based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of "acceptance criteria" with quantitative targets and corresponding "reported device performance" in a direct side-by-side comparison. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through compliance with a broad set of recognized standards and successful completion of non-clinical tests.

The document highlights the following general performance discussions:

• Waveform Performance: The HAMILTON-TC1 was subjected to waveform performance testing as described in Aston F1100-90. The data from these tests were shown to be substantially equivalent to the HAMILTON-C2.
• Airworthiness and Transport Aspects: For airworthiness and transport, the HAMILTON-TC1 is considered substantially equivalent to the Oxylog 3000. It compensates for altitude changes and has increased immunity to EMI.
• Altitude Testing: The HAMILTON-TC1 was placed inside an altitude chamber to test the effects on sensors and ventilator measurements/readings in a high-altitude, low-pressure environment. The detailed protocol and successful results were included in the submission.
• Software Verification and Validation: This testing demonstrated that all specified requirements have been implemented correctly and completely.
• Intended Use Compatibility: The intended use of the HAMILTON-TC1 is explicitly stated to be comparable to both predicate devices.
• Technological Characteristics: Design, material, and energy source are described as substantially equivalent to predicate devices.
• Max Inspiratory Flow:
  • HAMILTON-C2 (Predicate): 240 l/min
  • HAMILTON-TC1 (Proposed): 210 l/min
  • Comparison: Deemed "substantially equivalent."

The primary acceptance criteria are met through adherence to the following standards, ensuring safety and effectiveness:

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

The document does not specify a "sample size" for a test set in the context of a clinical study or a data set for an AI model.

The tests described are primarily engineering and bench testing for compliance with standards (e.g., ASTM F1100-90 for waveform testing, RTCA/DO-160F for environmental conditions, IEC standards for safety/EMC). For these types of tests, a single device or a small number of devices manufactured according to specifications are typically tested to ensure design compliance.

Data provenance is not applicable in the sense of patient data origin, as this is a device engineering and performance evaluation, not a clinical data analysis study.

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

N/A. This document pertains to the regulatory submission of a medical device (ventilator), not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from medical images or clinical data. The "ground truth" here is adherence to engineering standards and functional specifications.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where discrepancies in expert diagnoses or annotations need to be resolved. This is not relevant for the type of device performance testing described.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance. The HARTILTON-TC1 is a standalone ventilator device and not an AI-assisted diagnostic tool.

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

Yes, the studies described are standalone in the sense that they evaluate the device itself (HAMILTON-TC1) without explicitly measuring human-in-the-loop performance with an AI component. The ventilator's performance is tested against established engineering and safety standards. While the device has a "microprocessor system" and "alarm controller" with software, its overall functioning is as a medical device in itself, not an algorithm providing diagnostic or treatment recommendations that would typically be evaluated for standalone AI performance.

7. Type of Ground Truth Used

The "ground truth" in this context is based on:

• Engineering Standards and Specifications: The device's performance is compared against the requirements and methodologies outlined in various international and national standards (e.g., IEC 60601 series, ISO standards, ASTM F1100-90, RTCA/DO-160F).
• Performance of Predicate Devices: The HAMILTON-TC1's performance characteristics (e.g., waveform data, intended use, technological characteristics) are demonstrated to be "substantially equivalent" to legally marketed predicate devices (HAMILTON-C2 and DRAEGER Oxylog 3000), which serve as a benchmark for acceptable performance.
• Successful Completion of Non-Clinical Tests: This includes tests for safety, electromagnetic compatibility, environmental conditions (shock, vibration, altitude), software verification/validation, and specific functional tests like waveform analysis.

8. Sample Size for the Training Set

N/A. The HAMILTON-TC1 is a hardware-based medical device with integrated software, not a machine learning model that requires a distinct "training set" of data for learning or optimization in the typical AI sense. Software verification and validation are performed against defined requirements, not statistical training data.

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

N/A, for the reasons stated in point 8.

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