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The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients and optionally infant and neonatal patients by qualified, trained personnel under the direction of a physician.

Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer

When used on neonatal patients: The environment of use is the Neonatal Intensive Care Unit (NICU).

bellavista is an electronically controlled pneumatic ventilation system. It is powered by AC or DC and also provided with an internal battery. The bellavista pneumatic system supplies respiratory gas whilst the electrical systems control the pneumatics and provides the power supply.

The user can enter values or parameters in the bellavista via the touch screen. These inputs entail instructions for bellavista's pneumatic system to ventilate the patient with a precisely controlled gas mixture. bellavista gathers readings from the proximal flow sensor within the ventilator.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (ventilator). It describes the device, its intended use, a comparison to predicate devices, and the basis for substantial equivalence.

However, it does not include details about acceptance criteria, specific device performance numerical results, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case (MRMC) study or standalone algorithm performance, as these are typically part of a clinical validation study and not usually found in a 510(k) summary for a ventilator.

The document discusses the ventilatory support capabilities and patient populations for which the device is intended, but not the kind of detailed performance metrics usually required for AI/algorithm-based diagnostic devices.

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The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support or continuous flow of respiratory gases to adults and pediatrics, and optionally infants and neonates.

Intended areas of use:

· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room

· During transfer of ventilated patients within the hospital

The HAMILTON-C1 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-T1 ventilator is intended to provide positive pressure ventilatory support or continuous flow of respiratory gases to adults and pediatrics, and optionally infants and neonates.

Intended areas of use:

· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room

• · For emergency medical care
• · During transport within and outside the hospital
• · During transfer by rescue vehicles, fixed wing aircraft, helicopter or ship

The HAMILTON-T1 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-C1 and HAMILTON-T1 ventilators are designed for adults, pediatrics, infants and neonatal patients requiring invasive or non-invasive ventilation support. All ventilators cover a range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and Non-Invasive Ventilation.

The previously cleared ventilators, HAMILTON-C1 and HAMILTON-T1 (both K140939), have been bundled together in this 510(k) submission in order to add the following new features:

A modification to the software allows compatibility with the Nihon Kohden -SpO2 sensors to be used with HAMIILTON-C1 and HAMILTON-T1 ventilators. These ventilators are already compatible and cleared for use with Masimo SpO2 sensors (K140939).

• cFlow was added, which continuously delivers an air/gas mixture.
• -A modification to the software, which allows HAMILTON-C1/T1 ventilators to be compatible for use with speaking valves. A speaking valve allows tracheostomized adult and pediatric patients to communicate verbally.

The provided text describes the Hamilton-C1 and Hamilton-T1 ventilators and their clearance by the FDA. The submission focuses on adding new features to already cleared devices.

Here's an analysis of the provided information regarding acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria for the new features (cFlow, Speaking Valve, and Nihon Kohden SpO2 sensor compatibility) and their reported performance. Instead, it states that "the data provided from these tests was shown to be equivalent to the legally marketed devices." This implies that the acceptance criterion was equivalence to predicate/reference devices, and the reported performance met this criterion.

However, the "SUMMARY OF THE TECHNOLOGY AND PERFORMANCE SPECIFICATIONS COMPARISON WITH THE PREDICATED DEVICES" (Table 1 on pages 5-6) compares various parameters of the proposed HAMILTON-C1/T1 with the predicate HAMILTON-C1/T1 (K140939). For all listed parameters (Indications of Use, Control settings, Modes of ventilation, Alarms), the comparison states "Substantially Equivalent" or "Equivalent". While this table doesn't detail performance metrics for the new features, it confirms that the device, with its existing features, is considered equivalent to its predicate.

For the new features, the text mentions:

• cFlow: "cFlow was added, which continuously delivers an air/gas mixture." It later states, "The Nihon Kohden NKV-550 Series Ventilator System is used as a reference device for the proposed HAMILTON-C1/T1 as both the reference device and the proposed device are intensive care ventilators which have the O2 therapy/cFlow feature." This implies the cFlow feature in HAMILTON-C1/T1 is equivalent to that in the Nihon Kohden NKV-550.
• Nihon Kohden SpO2 sensors: "A modification to the software allows compatibility with the Nihon Kohden -SpO2 sensors to be used with HAMIILTON-C1 and HAMILTON-T1 ventilators." The document states, "The HAMILTON-C3 is used as a reference device for the proposed HAMILTON-C1/T1 as both the reference device and the proposed device are intensive care ventilators which can be used with Nihon Kohden SpO2 sensors and accessories." This suggests compatibility and performance with these sensors are equivalent to the HAMILTON-C3.
• Speaking Valve: "A modification to the software, which allows HAMILTON-C1/T1 ventilators to be compatible for use with speaking valves." "The Esprit Ventilator V200 with Speaking mode Option is used as a reference device for the proposed Speaking valve compatibility on the modified HAMILTON-C1/T1..." This indicates equivalence to the Esprit Ventilator V200's speaking mode.

Implicit Acceptance Criteria and Reported Performance for New Features:

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 does not specify exact sample sizes (e.g., number of patients, number of test cases) used for the comparison testing of the new features. It only states that "Testing of the modified HAMILTON-C1/T1, with the new features, was conducted."
The provenance of the data (country of origin, retrospective/prospective) is also not mentioned. The non-clinical performance tests are generally bench testing and software validation, not human studies.

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 section is not applicable as the document describes non-clinical performance tests for a ventilator, not diagnostic imaging or AI performance where human expert consensus would establish ground truth. The "ground truth" for these tests would be established through engineering specifications, validated test equipment, and established medical device standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The testing described is non-clinical performance and software validation, not a multi-reader clinical study requiring adjudication.

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. This is a ventilation device, not a diagnostic AI tool, so no MRMC study or AI assistance improvement for human readers would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not entirely applicable in the context of a ventilator. However, the software validation and bench testing can be considered "standalone" in the sense that the device's technical performance and software functions were tested independently of a human operator making clinical decisions or interpreting results in a real patient scenario. The tests confirm the device operates as intended according to its design specifications and relevant standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical performance tests and software validation would be based on:

• Engineering Specifications: The defined functional requirements and performance limits of the device.
• International and National Standards: Compliance with standards like ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-12, etc. (listed in Section IX) which define acceptable ranges and behaviors for critical care ventilators, electromagnetic compatibility, alarm systems, and usability.
• Predicate/Reference Device Performance: The established, legally marketed performance of the predicate HAMILTON-C1/T1 and the reference devices (Nihon Kohden NKV-550, HAMILTON-C3, Esprit Ventilator V200) for the new features. Equivalence to these cleared devices serves as a form of "ground truth" for substantial equivalence.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning product that requires a training set. The changes described are software modifications for compatibility and feature additions to a pre-existing ventilator design.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of medical device submission.

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