(176 days)
The HAMILTON-C6 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.
Intended areas of use:
• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
• During transfer of ventilated patients within the hospital
The HAMILTON-C6 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
The HAMILTON-C6 is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation.
The HAMILTON-H900 and IntelliCuff control options for the HAMILTON-C6 allow the remote control of the HAMILTON-H900 humidifier and IntelliCuff cuff pressure controller through the HAMILTON-C6 ventilator.
This document is a 510(k) summary for the Hamilton-C6 continuous ventilator. It focuses on demonstrating substantial equivalence to a predicate device (Hamilton-C3) and a reference device (Hamilton-G5), rather than providing details of an AI-based system. Therefore, much of the requested information regarding acceptance criteria and a study proving an AI device's performance cannot be extracted directly from this document.
However, I can provide information about the general performance criteria that were referenced for the device in question, a continuous ventilator.
1. A table of acceptance criteria and the reported device performance
The document does not provide specific numerical acceptance criteria (e.g., accuracy, sensitivity, specificity) with corresponding reported device performance values. Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Design and Validation | Demonstrated that the HAMILTON-C6 operates as intended. |
| Bench Testing | Demonstrated that the HAMILTON-C6 operates as intended. |
| Compliance with Guidelines and Standards | Compliant with: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, ISO 80601-2-12, ISO 80601-2-55, ISO 80601-2-61, AIM Standard 7351731, AAMI / ANSI HE75. |
| Software Verification and Validation | Conducted as recommended by FDA guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Software considered "major" level of concern. |
| Waveform Performance Testing (Ventilation Modes) | Data shown to be substantially equivalent to legally marketed devices. |
| Biocompatibility | Evaluated according to ISO 18562 series. Materials found acceptable for intended patient population and type of patient contact. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of an AI algorithm, nor does it provide details about sample sizes, data provenance, or whether data was retrospective or prospective. The testing mentioned appears to be general device performance and safety testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of device and testing described in the document. Ground truth for an AI algorithm is not mentioned as this is not an AI device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the type of device and testing described in the document.
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
No MRMC comparative effectiveness study was done as the HAMILTON-C6 is a continuous ventilator, not an AI-assisted diagnostic or interpretive device. There is no mention of human readers or AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The HAMILTON-C6 is a physical medical device (ventilator), not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not applied in this document, as it is a submission for a continuous ventilator, not an AI diagnostic/interpretive system. The "ground truth" used for performance testing of the ventilator would have been based on established engineering standards and validated physical measurements against expected device outputs.
8. The sample size for the training set
This information is not applicable to the type of device and testing described in the document. There is no training set for an AI algorithm mentioned.
9. How the ground truth for the training set was established
This information is not applicable.
§ 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).