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The Galileo Gold ventilator is intended to provide positive pressure ventilatory support to Adults, Pediatrics and Infants. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside or for intra-facility transport, provided compressed gas is supplied. The device is not intended for transport, outside the hospital or for use in the home environment.

The Galileo ventilator is a legally marketed intensive care ventilator (K982910, K001686). The four modifications included in this application are purely software-related and do not change the hardware of the Galleo Gold ventilator. This application is for the following options to the Galileo Gold ventilator: DuoPAP and APRV modes, NIV mode, MMV+ mode, and TRC feature.

Here's a summary of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes modifications to an existing ventilator (GALILEO Gold) rather than a novel device requiring specific clinical performance metrics like sensitivity, specificity, or accuracy for a diagnostic task. Therefore, the "acceptance criteria" here relate to demonstrating substantial equivalence to predicate devices and ensuring the new software features do not introduce safety or effectiveness concerns. The performance is reported in terms of successful testing and comparison to predicate devices.

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

The document describes software modifications to an existing device, and the testing focuses on functional verification and validation, rather than clinical trials with patient data.

• Test Set Sample Size: Not applicable in the traditional sense of a clinical trial test set. The "test set" consisted of various test cases, scenarios, and configurations for modular, integration, and system testing of the software features. Specific numbers of test cases or their characteristics are not provided in this summary.
• Data Provenance: The testing was conducted internally by Hamilton Medical AG (Switzerland) as part of the device modification and regulatory submission process. It is a prospective test in the sense that custom tests were designed and executed to verify the functionality of the new software. There is no indication of retrospective patient data being used.

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

Not applicable in the context of this type of device submission. Ground truth, in this context, would refer to the expected functional behavior and performance defined by engineering specifications, relevant standards (like ASTM F1100-93), and comparisons to legally marketed predicate devices. This is established through engineering design, regulatory standards, and comparison to existing, approved devices, not via expert consensus on clinical findings.

4. Adjudication Method for the Test Set:

Not applicable. The testing described is a verification and validation process against predefined specifications and predicate devices, not subjective clinical assessment requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers perform with and without an AI assistant, which is relevant for diagnostic or interpretive AI devices. The GALILEO Gold ventilator modification is a software update for a therapeutic device, not a diagnostic AI system.

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

Yes, in a sense. The core of the testing involved evaluating the new software features in a standalone capacity (i.e., the algorithm/software's execution and its impact on the ventilator's function) without explicitly human-in-the-loop performance studies as would be conducted for AI diagnostic tools. The "System tests were executed with a complete instrument, i.e. the new software together with the existing Galileo Gold hardware," which assesses the algorithm's performance within the device itself.

7. Type of Ground Truth Used:

The "ground truth" for this submission is based on:

• Engineering Specifications and Design Requirements: The new software features were developed to specific engineering criteria.
• Performance Standards: Compliance with relevant standards, such as ASTM Standard F1100-93 for ventilator performance.
• Functional Equivalence to Predicate Devices: The detailed comparison tables demonstrate that the new features function equivalently and do not introduce significant differences compared to the predicate devices.
• Absence of Deviations: The successful completion of modular, integration, and system testing without observed or documented performance deviations.

8. Sample Size for the Training Set:

Not applicable. This device is a medical ventilator with software modifications, not a machine learning or AI algorithm that requires a training set of data for learning patterns. The software is programmed with specific logic and control algorithms.

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

Not applicable, as there is no training set for this type of device. The software's "logic" is established through conventional software engineering and ventilator control algorithms, based on physiological principles and intended clinical functionality.

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The Galileo Ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients. The Galileo ventilator is intended for use where patient care is provided in the hospital and institutional environment. It is not intended for transport outside by health care professional environment or for home use.

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This document does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a letter from the FDA to Hamilton Medical, Inc. regarding the 510(k) premarket notification for the Hamilton Medical Galileo Ventilator.

The letter states that the device has been found substantially equivalent to legally marketed predicate devices and outlines the regulatory framework for marketing the device. It also includes an "Indications for Use" statement for the Galileo Ventilator.

Therefore, I cannot provide the requested information based on the input text.

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Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM). the device is intended for use within the hospital or institutional environment.

Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM).

This document is a 510(k) premarket notification letter from the FDA to Hamilton Medical, Inc. for the Aladdin II Monitoring Oxygen/Air Mixer. It primarily discusses the regulatory classification and marketing authorization for the device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about device performance, sample sizes, ground truth establishment, or expert reviews as requested in the prompt.

Therefore, I cannot provide the requested information based on the given text. The text does not describe a study or device performance data.

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