(266 days)
The HAMILTON-C3 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-C3 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-C3 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 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-C3:
• Therapy type: HiFlowO2
The provided document is a 510(k) summary for the Hamilton-C3 ventilator, seeking to add a "HiFlowO2" therapy type. This document does not describe acceptance criteria for a device's performance in a diagnostic or predictive capacity, nor does it detail a study that proves a device meets such criteria in the way a clinical trial for an AI diagnostic might. Instead, it describes compliance with regulatory standards and a bench test to show equivalence for a new feature.
Therefore, many of the requested elements for describing acceptance criteria and a study (like sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not available within this regulatory submission.
However, I can extract information related to the device's technical specifications and how the new feature was evaluated for substantial equivalence.
Here's the closest representation of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for the HiFlowO2 feature in a quantitative form with specific thresholds (e.g., "accuracy > X%"). Instead, the acceptance criterion for the new HiFlowO2 therapy type is substantial equivalence to the reference device (HAMILTON-G5) regarding its flow and oxygen values.
| Criterion Type | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| General Safety & Performance | Compliance with various international standards for medical electrical equipment, software, and ventilators (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, -1-6, -1-8, IEC 62304, IEC 62366, ISO 80601-2-12, -2-55, -2-61, IEC 80601-2-49). | "The software design and validation process, together with the bench testing of the device, demonstrated that the HAMILTON-C3 operates as intended." The HAMILTON-C3 was found to be compliant with all listed guidelines and standards. |
| HiFlowO2 Therapy Type Equivalence | Substantial equivalence in flow and oxygen values to the HAMILTON-G5 (reference device) for the HiFlowO2 therapy type. | HiFlowO2 Flow Range (Comparison to HAMILTON-G5): |
- Neonatal: HAMILTON-C3 (2 to 12 l/min) vs. HAMILTON-G5 (1 to 12 l/min) — Similar
- Adult/Pediatric: HAMILTON-C3 (2 to 60 l/min) vs. HAMILTON-G5 (1 to 60 l/min) — Similar
HiFlowO2 Default Settings (Comparison to HAMILTON-G5):
- Flow Adult/Pediatric: HAMILTON-C3 (15 l/min) vs. HAMILTON-G5 (15 l/min) — Same
- Flow Neonatal: HAMILTON-C3 (2 l/min) vs. HAMILTON-G5 (1 l/min) — Similar
- Oxygen Adult/Pediatric: HAMILTON-C3 (50%) vs. HAMILTON-G5 (50%) — Same
- Oxygen Neonatal: HAMILTON-C3 (40%) vs. HAMILTON-G5 (40%) — Same
"The data provided from this test was shown to be substantially equivalent to the legally marketed predicate device [referring to the reference device for HiFlowO2]." |
The "predicate device" and "reference device" mentioned in the document are already legally marketed and cleared devices. The Hamilton-C3, with the new HiFlowO2 feature, is being compared to these existing devices to demonstrate that it is "substantially equivalent" and therefore safe and effective.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified in terms of patient or case numbers. The evaluation of the HiFlowO2 feature was conducted via a bench test. Bench tests typically involve testing the physical device's performance under simulated conditions, not using patient data.
- Data provenance: Not applicable in the context of patient data, as the testing was non-clinical (bench testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The ground truth for a bench test typically involves calibrated measurement equipment and engineering standards, not expert human interpretation of medical cases.
4. Adjudication method for the test set
- Not applicable. This type of testing does not involve human adjudication of medical findings.
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. This is a submission for a ventilator with a new therapy type, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is for a medical device (ventilator), not an algorithm that performs a diagnostic or predictive function. The "study" mentioned is a bench test to verify the physical performance of the ventilator with its new feature.
7. The type of ground truth used
- For the bench test of the HiFlowO2 feature: The "ground truth" would be the measured physical outputs (flow rates and oxygen concentrations) from the Hamilton-C3 device, compared against the specifications and expected performance based on the reference device (HAMILTON-G5) and engineering principles. This is not medical ground truth like pathology or expert consensus.
- For software validation and overall device compliance: The "ground truth" is adherence to established international standards (e.g., IEC 60601 series, ISO 80601 series, IEC 62304) and internal design specifications.
8. The sample size for the training set
- Not applicable. There is no AI model or algorithm being "trained" in the context of this regulatory submission based on the provided text.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
§ 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).