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The RAPHAEL Color^sV ventilator is a continuous ventilator designed for ventilation of adult and pediatric patients weighing between 5 and 200 kg. The RAPHAEL ColorASV ventilator is intended for use by properly trained personnel under direct supervision of a licensed physician. The RAPHAEL Color450 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 Color's is a software modified version of the legally marketed device RAPHAEL Color (K052863). The RAPHAEL Color^SV is a full-functioned intensive care ventilator. It can ventilate adult and pediatric patients weighing between 5 and 200 kg. The RAPHAEL Color488 offers a full spectrum of modalities, from the conventional to the new included Adaptive Support Ventilation, ASV. ASV is designed to maintain at least the minute ventilation set by the clinician. ASV does this without exceeding a preset plateau pressure. ASV provides full ventilation in apnea or low-drive conditions, and then automatically returns control to the patient as spontaneous ventilation begins. ASV works automatically by continuous repetition of 3 steps: 1. Assess the patient breath-by-breath. 2. Calculate an optimal breath pattern based on the minimal work of breathing method by Otis (J Appl Physiol 1950: 592-607). 3. Approach the target by automatically adjusting mandatory rate and inspiratory pressure.

The Hamilton Medical RAPHAEL ColorASV is a software-modified version of the RAPHAEL Color (K052863) continuous ventilator, with the addition of the Adaptive Support Ventilation (ASV) mode. The ASV mode itself is comparable to the ASV mode found in the HAMILTON GALILEO GoldASV (K061090) ventilator.

Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a typical "Pass/Fail" or quantitative threshold format. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through performance testing.

Study Details:

1. Sample Size used for the test set and the data provenance:

   • The submission describes "performance/qualification testing" on "modular, integration and system level." It also mentions evaluation in accordance with "ASTM Standard F1100-90."
   • However, specific sample sizes (e.g., number of test conditions, simulated patient scenarios, or test cycles) are not explicitly stated in the provided text.
   • The data provenance is internal testing performed by Hamilton Medical AG ("Switzerland" is the country of origin for the 510(k) owner). The testing is non-clinical/bench testing.

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

   • This was a non-clinical, bench testing study. Therefore, there were no human experts establishing ground truth in the context of clinical outcomes or imaging interpretation. The "ground truth" was based on meeting engineering specifications, adherence to standards (ASTM F1100-90), and comparison against the known performance of predicate devices.

3. Adjudication method for the test set:

   • Not applicable as this was non-clinical performance testing. The "adjudication" would have been through verification against specified performance parameters and standard compliance by the manufacturer's testing personnel.

4. 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, an MRMC comparative effectiveness study was not performed as this device is a continuous ventilator, not an AI-assisted diagnostic tool for human readers.

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

   • The testing described is essentially "standalone algorithm/device performance" in a simulated, non-clinical environment. The ASV algorithm's performance and the overall ventilator's function were tested without direct human-in-the-loop performance in a clinical setting for this particular submission. The "algorithm" (ASV mode) was tested as an integral part of the device's functionality.

6. The type of ground truth used:

   • The "ground truth" for this ventilator was based on engineering specifications, compliance with relevant industry standards (e.g., ASTM F1100-90), and demonstrated equivalence to the performance of legally marketed predicate devices. It was not based on expert consensus, pathology, or patient outcomes data in this submission, as it focused on device safety and functional performance.

7. The sample size for the training set:

   • The RAPHAEL ColorASV is a ventilator with an embedded control algorithm (ASV). The ASV mode itself is based on a method described by Otis (J Appl Physiol 1950: 592-607). This is not a machine learning or AI algorithm that undergoes a "training set" in the modern sense. Therefore, there is no stated sample size for a training set. The algorithm's parameters are likely based on physiological models and engineering design rather than data-driven machine learning.

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

   • As established above, this is not a machine learning algorithm with a training set. The ASV algorithm's underlying "ground truth" or design principles are based on established physiological models of respiratory mechanics and work of breathing, as evidenced by the reference to Otis's method. The development of such control algorithms involves engineering design, mathematical modeling, and physiological understanding, rather than empirical training data with associated ground truth labels.

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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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The RAPHAEL ventilator is a continuous ventilator designed for ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg, The RAPHAEL ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The RAPHAEL ventilator 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 is an microprocessor controlled critical care ventilator system. RAPHAEL supplies mandatory or spontaneous breaths with the preset oxygen concentration to provide continuous ventilation for adult, pediatric, and infant patients weighing between 5 and 200kg. It is powered by AC with a battery backup to protect against power failure or unstable power and to facilitate intrahospital transport. The user interface consists of a LCD-display, a display panel keyboard to open windows, and central rotary dial knob (press-and-turn element) for selecting, setting, and confirming inside the window. The user provides inputs to the RAPHAEL microprocessor system through the keys and the press-and-turn element. RAPHAEL provides audible and visual patient-related, and ventilator-related alarms. Accessories to connect RAPHAEL to the patient airway opening are the same as for GALILBO, found substantially equivalent in the 510(k) file number K001686.

The provided text is a 510(k) summary for the RAPHAEL ventilator. It describes the device, its intended use, and states its substantial equivalence to other legally marketed devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information from the given text. The 510(k) summary focuses on regulatory approval based on equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.

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