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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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