(337 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, paediatric, 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:
- The following two new ventilation modes for adult / pediatric patient group: ● (S)CMV and SIMV
- SpO2 monitoring option
This section describes the acceptance criteria and the study proving the device meets those criteria, based on the provided text.
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Guidelines/Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment General - Requirements for Safety | Compliant; all applicable requirements met. |
| IEC 60601-1-2 (2014): Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests | Compliant; all applicable requirements met. |
| ISO 80601-2-12 (2011): Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | Compliant; all applicable requirements met. |
| IEC 60601-1-8 (2006 + Am.1: 2012): Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | Compliant; all applicable requirements met. |
| IEC 60601-1-6 (2010 + A1 :2013): Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Compliant; all applicable requirements met. |
| IEC 62366 (2008)+A1(2014): Medical devices Application of usability engineering to medical devices | Compliant; all applicable requirements met. |
| IEC 62304 (2006): Medical device software Software life-cycle processes | Compliant; additional software verification and validation testing conducted as recommended by FDA guidance. Software considered a "major" level of concern. |
| ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | Compliant; all applicable requirements met. |
| ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | Compliant; all applicable requirements met. |
| Performance of new ventilation modes ((S)CMV and SIMV) | Waveform performance testing conducted, and data shown to be substantially equivalent to legally marketed devices (specifically, the HAMILTON-G5 which uses the same algorithms for these modes). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The provided text focuses on device performance testing against regulatory standards and software validation. It mentions "waveform performance testing" for the new ventilation modes. However, it does not specify the sample size for any test sets used in performance testing, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective nature of data).
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 provided in the document. The testing described is primarily technical compliance and performance against established engineering standards and validated software functionality, rather than a clinical study requiring expert ground truth for interpretation of outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. The text describes bench testing and software validation, not a study design involving adjudication of human interpretations.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the provided text. The device is a ventilator, and the testing described is related to its technical performance and safety, not a diagnostic or interpretive AI system that human readers would use.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document describes "Software Design and Validation" processes, "bench testing of the device," and "waveform performance testing" for the new ventilation modes. These types of tests are inherently "standalone" in that they evaluate the device's algorithmic and mechanical performance directly against engineering specifications and expected outputs, without direct human intervention as part of the core performance measurement, other than operating the test equipment. So, yes, standalone algorithm performance was assessed though not explicitly called out as such.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's technical performance and safety is derived from the international and national standards and guidelines listed (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-12). For the new ventilation modes, "waveform performance testing" was conducted, implying that the ground truth for correct operation were the expected waveform characteristics and parameters as defined by the ventilator's design specifications and the algorithms derived from the predicate HAMILTON-G5.
8. The sample size for the training set:
A "training set" is typically associated with machine learning or artificial intelligence models. As this document describes a medical device (ventilator) and its compliance with technical standards and software validation, there is no mention of a training set in the context of machine learning. The "training" for such a device would refer to its design, development, and engineering phases.
9. How the ground truth for the training set was established:
Since there is no mention of a training set in the context of machine learning, this question is not applicable. The "ground truth" for the device's design and functionality is established through engineering principles, medical device regulatory requirements, and the functionalities of predicate devices.
§ 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).