(90 days)
The GALILEO Gold ASV 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 for intra-facility transport, provided compressed gas is supplied. The device is not intended for transportation outside the hospital or for use in the home environment.
The GALILEO Gold N is a software modified version of the legally marketed device GALILEO Gold (K040574). The GALILEO Gold SV is a full-functioned intensive care ventilator. It can ventilate adult, pediatric and infant patients. The GALILEO Gold*ASV 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, then automatically returns control to the patient as spontaneous ventilation begins. ASV works automatically by continuous repetition of 3 steps:
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- Assess the patient breath-by-breath.
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- Calculate an optimal breath pattern based on the minimal work of breathing method by Otis (J Appl Physiol 1950: 592-607).
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- Approach the target by automatically adjusting mandatory rate and inspiratory pressure.
The provided document focuses on the Hamilton Medical GALILEO GoldASV ventilator and its substantial equivalence to predicate devices, rather than an AI-powered diagnostic device. Therefore, a direct application of the requested acceptance criteria and study details for an AI-powered device is not fully applicable.
However, I can extract the relevant information regarding the performance and safety assessment of the GALILEO GoldASV ventilator, specifically its new ASV mode, and structure it as closely as possible to your request for an AI device, by interpreting "acceptance criteria" as the demonstration of safety and effectiveness.
Here's an analysis based on the provided text:
Device: GALILEO GoldASV Ventilator (specifically the new ASV mode)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Interpreted) | Reported Device Performance (Summary) |
|---|---|
| Safety and Effectiveness of the ASV mode with closed-loop control | "Assessment and clinical performance data affirm that the ASV mode using RCero as feedback signal for the closed-loop control is safe and effective." "User assessments show that the extended ASV mode is as safe, as effective, and performs clinically as well as the predicate devices." |
| No performance deviations during testing (modular, integration, system level) | "There were no performance deviations observed or documented during testing." |
| Compliance with ASTM Standard F1100-93 | "The ventilator performance has been further evaluated in accordance to the ASTM Standard F1100-93. No new question raised regarding safety and effectiveness of the complete instrument and its new feature." |
| Absence of adverse effects, complications, or required reintubation in clinical use of ASV | "Performance data of patients with normal lungs and diverse respiratory failures, ventilated with the ASV technology are on hand with no adverse effects, complications or required reintubation reported." |
| Impact of new software on microcomputer system | "The impact of the new software on the microcomputer system was tested and documented. No performance deviations were observed or documented during testing." |
| Substantial equivalence to predicate devices (GALILEO Gold K040574 and Dräger EvitaXL K051263) | "The ventilator GALILEO GoldASV is except for the use of a closed-loop controller in the new added ASV mode substantially equivalent in safety and effectiveness to the HAMILTON GALILEO Gold ventilator (K040574)." "The closed-loop controller using a physiological feedback signal is comparable with the closed-loop controller used in the SmartCare mode of the predicate device Dräger EvitaXL (K051263)." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a numerical value for a "test set" in the context of an AI study. The document refers to "Performance data of patients with normal lungs and diverse respiratory failures, ventilated with the ASV technology."
- Data Provenance: Not specified, but likely from clinical settings where the ASV technology was used. No country of origin is mentioned, nor is it explicitly stated as retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable here as the device is a ventilator, not an AI diagnostic system requiring expert-established ground truth for a test set. The efficacy and safety are assessed through engineering tests and clinical observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The assessment involves performance testing and clinical observation, not expert adjudication of diagnostic outcomes.
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 ventilator, not an AI-assisted diagnostic tool for human readers. The document highlights "User assessments show that the extended ASV mode is as safe, as effective, and performs clinically as well as the predicate devices," suggesting a comparison of the device's performance to existing ones, but not an MRMC study with human readers and AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone ventilator with an automated ASV mode (a closed-loop controller). Its performance was evaluated on its own ("The performance/qualification testing of the new added GALILEO Gold feature ASV has been done on modular, integration and system level"). The ASV mode operates automatically by continuous repetition of steps, implying an algorithm-only function once set up by the clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for a ventilator's performance is typically established through:
- Engineering specifications and testing (e.g., meeting flow and pressure targets).
- Physiological outcomes data (e.g., maintained minute ventilation, not exceeding plateau pressure, automatic control return as spontaneous ventilation begins).
- Clinical observations and "no adverse effects, complications or required reintubation" as reported from patient data.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model trained on a specific dataset. The "training" for the ventilator's algorithm is embedded in its design based on physiological principles (e.g., minimal work of breathing method by Otis).
9. How the ground truth for the training set was established
Not applicable, as it's not an AI training set in the conventional sense. The "ground truth" for the ASV algorithm's behavior is rooted in established physiological models and engineering principles to achieve desired ventilatory support.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).