(544 days)
The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-G5 ventilator may be used for transport within a hospital or hospital type facility provided compressed gas is supplied. The device is not to be used in the presence of flammable anesthetic agents or other ignition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. The device is not intended for transportation outside the hospital or for use in the home environment.
The HAMILTON-G5 is designed for adult, pediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a range of clinical modes, including invasive ventilation, Adaptive Support Ventilation (ASV), and noninvasive ventilation. The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-G5: The following new feature for adult, pediatric, infant and neonatal patient group: cFlow
Based on the provided text, the acceptance criteria and study information for the HAMILTON-G5 ventilator are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI ES60601-1 (2005/(R) 2012): Medical electrical equipment General Re-quirements for Safety | Compliant |
| 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 |
| ISO 80601-2-12 (2011): Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | Compliant (Met ISO 80601-2-12 requirements on essential performance of critical care ventilator, also for the reference device) |
| 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 |
| IEC 60601-1-6 (2010 + A1:2013): Medical electrical equipment Part 1-6: General re-quirements for basic safety and essential performance - Collateral standard: Usability | Compliant |
| IEC 62366 (2014): Medical devices - Application of usability engineering to medical devices | Compliant |
| ANSI/AAMI HE75(2009(R) 2013): Human factors engineering – Design of medicaldevices | Compliant |
| IEC 62304 (2006): Medical device software Software life-cycle processes | Compliant |
| ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gasmonitors | Compliant |
| ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | Compliant |
| Software Design and Validation Process (for "major" level of concern software) | Demonstrated that the HAMILTON-G5 operates as intended. |
| Comparison testing of new cFlow feature with legally marketed devices | Data shown to be equivalent to legally marketed devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" for the test set in terms of patient data or case numbers. It refers to "bench testing of the device" and "comparison testing with legally marketed devices" for the cFlow feature.
The data provenance is implied to be retrospective in the sense that the device is being compared against already marketed devices (both predicate and reference devices) and established standards. There is no indication of prospective clinical trials in this 510(k) summary. The testing appears to be primarily laboratory/bench-based and validation of software and device performance against technical standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document mentions "properly trained personnel under the direct supervision of a licensed physician" for its intended use, but not for the establishment of ground truth during testing. The "ground truth" for this device appears to be defined by adherence to recognized international technical standards and comparison to previously cleared devices.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the testing described (compliance with technical standards, bench testing, software validation, and comparison to predicate/reference devices), a formal adjudication method like 2+1 or 3+1 typically used in image-based diagnostic AI studies is not applicable or mentioned.
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 done and is not applicable to this device described. The HAMILTON-G5 is a medical ventilator, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable as this is a medical ventilator. The device itself operates as a standalone system (an "algorithm only" analogy here would be the ventilator's internal software controlling ventilation parameters). The "human-in-the-loop" is the healthcare professional operating and monitoring the ventilator, as per its indications for use. The performance data refers to the device's technical compliance and functional equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this submission is primarily:
- Compliance with recognized international technical standards (e.g., ISO, IEC, ANSI/AAMI standards for medical electrical equipment and ventilators).
- Functional equivalence to legally marketed predicate and reference devices (HAMILTON-G5 K131774 and Nihon Kohden NKV-550 Series Ventilator System K181695).
- Intended operation as designed as demonstrated through software design and validation processes and bench testing.
8. The sample size for the training set
The concept of a "training set" in the context of machine learning or AI is not applicable here. The HAMILTON-G5 is a traditional medical device (ventilator) with added features, not an AI/ML-driven model that undergoes training on a dataset. The software itself is validated, but not "trained" in the AI sense.
9. How the ground truth for the training set was established
As explained above, there is no "training set" in the AI/ML context for this device. The verification and validation activities were based on established engineering principles, regulatory standards, and comparison to existing cleared 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).