(152 days)
The GALILEO Gold ventilator is intended to provide positive pressure ventilatory support to adult, pediatric, infant, and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use at the patient bedside and for intrafacility 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 is an electronically controlled pneumatic intensive care ventilation system. It uses oxygen and air to ventilate adult, pediatric, infant, and neonatal patients. It is powered by ac with battery backup to protect against power failure or unstable power and to facilitate intrahospital transport. The GALILEO Gold's pneumatics deliver gas, and its electrical systems control pneumatics, monitor alarms, and distribute power. The user interface consists of a LCD-display with touch screen, keys, and a press-and-turn knob. The GALILEO Gold provides audible and visual patient- and ventilator-related alarms.
The provided text describes the HAMILTON MEDICAL GALILEO Gold ventilator, but it does not contain the detailed information necessary to complete a table of acceptance criteria and the study that proves the device meets those criteria, as typically required for AI/machine learning device submissions.
The document is a 510(k) summary for a continuous ventilator, which is a hardware medical device rather than an AI/ML-driven software device. Therefore, the information provided focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and nonclinical performance (waveform testing), rather than on specific acceptance criteria and detailed study results for an AI algorithm's performance.
Here's a breakdown of why the requested information cannot be fully provided based on the input:
- Acceptance Criteria and Device Performance: The document states "The ventilator was subject to wave-form performance testing as described in the standard F1100 - 90. The data provided from these tests, were shown to be substantially equivalent to a legally marketed device." It does not list specific numerical acceptance criteria (e.g., accuracy, sensitivity, specificity) or the quantitative reported performance of the device against such criteria.
- Sample Size for Test Set and Data Provenance: No information on a "test set" in the context of AI/ML performance evaluation is provided. The testing mentioned is "wave-form performance testing," which likely involves engineering tests rather than patient studies for algorithm validation.
- Number of Experts and Qualifications: Not applicable to this type of device submission.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable, as this is a hardware ventilator, not an AI-assisted diagnostic tool.
- Standalone Performance: While the device has standalone performance in terms of its ventilation capabilities, it's not a standalone algorithm in the AI/ML sense.
- Type of Ground Truth: Not applicable in the context of AI/ML. The "ground truth" for a ventilator would be its physical performance against engineering standards.
- Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable, as this is not an AI/ML device.
In summary, the provided 510(k) for the GALILEO Gold ventilator is for a traditional medical device and does not include the type of AI/ML performance acceptance criteria, study details, or ground truth methodologies that your request anticipates. The approval is based on substantial equivalence to predicate devices and nonclinical performance testing against industrial standards (like F1100-90) for its ventilation functions and safety.
§ 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).