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The HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:

• In the MRI department
• 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-MR1 ventilator is classified as MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners.
  The HAMILTON-MR1 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-MR1 is an MR-Conditional ventilator which increases the availability of appropriate modes of therapy for ventilated hospital patients requiring MR imaging. It is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation. It can be used at the gauss line, in the presence of either 1.5T or 3T MRI machines.
With the shielded, MRI-compatible HAMILTON-MR1 ventilation performance and MR image quality is as safe and as effective as the predicate device throughout the MRI procedure. The integrated gaussmeter is programmed to alarm when the clinician is placing the HAMILTON-MR1 too close to the MRI magnet, which helps the clinician to properly position the HAMILTON-MR1 at the 50mT (500 gauss) line or less.
The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-MR1:

• Neonatal patients with a minimum weight of 0.2 kg and a minimal tidal volume of 2 mL
• . The following two new modes for the neonatal patient group: nCPAP and nCPAP-PC
• An increase in the battery duration from 5 hours and 20 minutes to 9 hours and 20 minutes.

The provided document describes a 510(k) submission for the HAMILTON-MR1 ventilator, focusing on its substantial equivalence to previously cleared predicate devices. The submission concerns adding new features, specifically the capability to ventilate neonatal patients and two new ventilation modes (nCPAP and nCPAP-PC).

This document does not include information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven medical device, as it is a ventilator and not an AI/ML diagnostic tool. Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to this type of device submission.

However, I can extract information regarding performance testing and regulatory compliance relevant to this specific device.

Acceptance Criteria and Device Performance (Based on the provided document)

Since this is a ventilation device rather than an AI/ML diagnostic, "acceptance criteria" here refer to compliance with relevant medical device standards and demonstrating functionality for the newly added features.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (Contextualized for a Ventilator Submission):

2. Sample size used for the test set and the data provenance:

• This document does not specify a "test set" in terms of patient data or clinical trials, as it's a 510(k) for a ventilator modification based on bench testing, engineering verification, and comparison to predicate devices, rather than a clinical performance study involving human subjects.
• The data provenance is from bench testing and software verification/validation activities conducted in support of the submission. The company is Hamilton Medical AG, located in Bonaduz, Grisons, Switzerland. The testing is implied to be prospective as it was conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable in the context of this 510(k) submission for a ventilator. Ground truth as typically defined for AI/ML diagnostic devices (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance is its adherence to engineering specifications and international standards, demonstrated via bench testing and engineering verification.

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

• Not applicable. This relates to clinical study design for image interpretation or diagnosis, which is not part of this ventilator submission.

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:

• No. This is a ventilator, not an imaging device or an AI assistant for human readers. MRMC studies are not relevant to this submission.

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

• Not applicable. The device is a ventilator, a physical machine that provides mechanical ventilation. Its "performance" is its ability to deliver specified ventilation parameters safely and effectively, not an algorithm's diagnostic output.

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

• The "ground truth" for this ventilator device is its compliance with internationally recognized medical device standards (e.g., IEC, ISO, ANSI/AAMI), its engineering specifications, and its demonstrated performance in bench testing (e.g., waveform performance testing for new ventilation modes, magnetic immunity, RF-noise generation). The comparison to predicate devices also serves as a baseline for "truth" in terms of substantial equivalence.

8. The sample size for the training set:

• Not applicable. This device does not use an AI/ML model that requires a training set.

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

• Not applicable. No training set is used for this device.

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