(164 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 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 ventilator is designed for adults, pediatrics, infants and neonates requiring invasive or non-invasive 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:
- IntelliSync+, an option that allows the device to dynamically update the inspiratory or cycling trigger
- Operation of the humidifier HAMILTON-H900 via the GUI of the ventilator HAMILTON-G5
This document, an FDA 510(k) summary for the Hamilton-G5 ventilator, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria and results in the way one might typically describe for an AI/ML device. The "performance data" section primarily lists compliance with various medical device standards and general software validation.
Specifically, there is no detailed acceptance criteria table, no sample size for test sets (in the context of clinical performance evaluation), no information on experts, adjudication methods, MRMC studies, or standalone algorithm performance, no specific ground truth establishment methodologies from patient data, and no details regarding training sets.
The document states:
- "Testing of the new feature IntelliSync+ with the HAMILTON-G5 was conducted by waveform performance testing. The data provided from this test was shown to be substantially equivalent to the legally marketed predicate device."
This indicates that the performance evaluation for the new feature was a bench test involving waveform analysis, comparing it to a predicate device's performance characteristics. This is typical for ventilator predicate equivalence submissions, where the "performance" often refers to meeting engineering specifications rather than clinical outcomes studies with human readers.
Therefore, based solely on the provided text, I cannot generate the requested table and detailed study description. The document does not contain the information needed to fill out points 1 through 9 as they typically apply to AI/ML device performance studies.
However, I can extract what is available about the performance, even if it's not in the requested format for an AI/ML device:
Device: Hamilton-G5 Ventilator (with new features IntelliSync+ and HAMILTON-H900 GUI integration)
Study Type: Technical Performance Bench Testing (for the new features) and compliance with industry standards. No clinical trial data is described.
Summary of available information related to performance/acceptance (limited, not in AI/ML performance study context):
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Table of Acceptance Criteria and Reported Device Performance:
Criteria Category (Not formal "acceptance criteria" but compliance metrics) Reported Device Performance/Compliance Software Design & Validation "The software design and validation process, together with the bench testing of the device, demonstrated that the HAMILTON-G5 operates as intended." "Software verification and validation testing was conducted and documentation was provided as recommended by the FDA's 'Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" The software was considered a "major" level of concern. IntelliSync+ Trigger Performance "Testing of the new feature IntelliSync+ with the HAMILTON-G5 was conducted by waveform performance testing. The data provided from this test was shown to be substantially equivalent to the legally marketed predicate device." (Comparison to predicate Respironics V200 Ventilator's Auto-Trak trigger functionality: "The subject device HAMLTON-G5 is compared to the Respironics V200 Ventilator regarding the trigger synchronization algorithm, which resulted in equivalence regarding the trigger features itself and in substantial equivalence regarding the trigger performance.") Compliance with Standards - ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment General l Requirements for Safety
- 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
- ISO 80601-2-12 (2011): Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- 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
- IEC 60601-1-6 (2010 + A1 :2013): Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366 (2014): Medical devices Application of usability engineering to medical devices
- ANSI/AAMI HE75(2009(R) 2013): Human factors engineering – Design of medical devices
- IEC 62304 (2006): Medical device software - Software life-cycle processes
- ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| Biocompatibility | "Since only materials already used in the primary predicate... are used (the new features did not include any material changes, only software adaptions) Hamilton Medical did not conduct any additional biocompatibility testing." |
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Sample size used for the test set and the data provenance:
- No "test set" in the sense of patient data is mentioned. The testing was "waveform performance testing" (a bench test). No information on the number of waveforms or their origin is provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable; this was a bench test against technical specifications and comparison to a predicate device's technical performance, not a study requiring expert readers to establish ground truth from patient data.
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Adjudication method for the test set:
- Not applicable.
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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 ventilator, not an AI diagnostic imaging device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The "waveform performance testing" seems to be a standalone technical performance evaluation of the IntelliSync+ algorithm's ability to interpret and respond to waveforms, comparing its output to that of a predicate device. It's not a clinical standalone study as typically understood for AI/ML diagnostics.
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The type of ground truth used:
- For IntelliSync+ performance, the "ground truth" seems to be the expected/measured physiological characteristics of waveforms and the performance of the legally marketed predicate device's trigger algorithm (Auto-Trak) in relation to those waveforms. This is a technical/engineering ground truth, not a clinical ground truth from patient outcomes or pathology.
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The sample size for the training set:
- Not applicable. The document describes software modifications and integration of features, not a machine learning model that requires a "training set."
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How the ground truth for the training set was established:
- 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).