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The RAPHAEL Color ventilator is a continuous ventilator designed for ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg. The RAPHAEL Color ventilator is intended for use by properly trained personnel under direct supervision of a licensed physician. The RAPHAEL Color is intended for use in a hospital or hospital-type facility, including use at a patient bedside or for intra-facility transport, provided compressed gas is supplied.

The RAPHAEL ventilator is a legally marketed intensive care ventilator (K022679). The two modifications included in this application are purely software-related and do not change the hardware of the RAPHAEL ventilator. This application is for the following options to the RAPHAEL Color: . The NIV (Non-Invasive Ventilation) mode is designed to facilitate ventilation assistance in a non-invasive way (e.g. a facial, a nasal mask or a mouth piece) between the ventilator and the patient's airway. TRC (Tube Resistance Compensation) is a feature to minimize the patient's work of . breathing to overcome the additional airway resistance due to the presence of an ET-tube or a tracheotomy tube.

The provided documentation describes the RAPHAEL Color Ventilator Modification 510(k) submission, focusing on the addition of two software-related features: Non-Invasive Ventilation (NIV) mode and Tube Resistance Compensation (TRC). The primary objective of the submission is to demonstrate substantial equivalence to a predicate device, the GALILEO Gold ventilator.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable format with specific benchmarks. Instead, it frames the performance evaluation in terms of demonstrating substantial equivalence to the predicate device (GALILEO Gold) for the new NIV and TRC features. The "acceptance criteria" can be inferred as showing "no significant differences" in technological performance characteristics and "no performance deviations" during testing.

The document explicitly states: "There are no significant differences between the new RAPHAEL Color features and its predicate." and "As presented during the accompanying documentation, there were no performance deviations observed or documented during modular, integration, and system testing." The graphical analysis of waveforms also indicated "no new question raised regarding safety and effectiveness."

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

The document describes "modular, integration, and system test level" testing. It mentions that "System tests were executed with a complete instrument." However, specific sample sizes for these test sets are not provided.

Regarding data provenance, the testing was conducted by Hamilton Medical AG, a Swiss company, for its product. This implies the data originates from internal company testing. The document does not specify if the testing was retrospective or prospective, but given it's part of a 510(k) submission for new software features, it is likely prospective testing conducted specifically for this submission.

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

The document does not specify the number of experts used or their qualifications to establish ground truth for the test set. The evaluation primarily relies on internal engineering and performance testing against the predicate device and established standards (like ASTM F-1100-93).

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method like 2+1 or 3+1. The testing described appears to be technical performance verification performed by the manufacturer's engineers against design specifications and predicate device characteristics, rather than expert-based adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence of the new software features of a medical device (ventilator) to a predicate device based on technical performance testing, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

The performance evaluation described is for the standalone algorithm (software features) integrated into the RAPHAEL Color ventilator. The testing focused on how these new software modes (NIV and TRC) performed within the complete instrument, independent of direct "human-in-the-loop" performance studies in a clinical setting. The "human-in-the-loop" equivalent in this context would be a clinical trial comparing patient outcomes, which is not detailed here.

7. The Type of Ground Truth Used:

The "ground truth" for the test set is established by the performance specifications of the new software features and their demonstrated equivalence to the characteristics of the legally marketed predicate device (GALILEO Gold), as well as compliance with relevant standards (ASTM F-1100-93). This is a technical, engineering-based ground truth, not based on expert consensus, pathology, or outcomes data in the usual sense of a diagnostic medical device.

8. The Sample Size for the Training Set:

The document does not mention any training set size. This is because the new features (NIV and TRC) are described as "purely software-related" modifications to an existing ventilator. The development of these modes likely involves engineering design and validation, not machine learning or AI models that require explicit training data sets.

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

As there is no mention of a training set, there is no information on how its ground truth was established. The development of these software features for a ventilator typically involves engineering principles, physiological models, and adherence to established ventilation protocols rather than a data-driven "training" approach.

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