(274 days)
The GMX Series Medical Air/Oxygen Blender is designed to dispense a continuous blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients.
The GMX Series Medical Air/Oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of air/oxygen mixtures is required. The GMX Series Medical Air/Oxygen blender includes two models: GMX30U-AIR/O2, GMX120U-AIR/O2. The GMX Series Medical Air/Oxygen blender is designed, tested, and will be manufactured in accordance with the following standard: ISO 11195 Gas mixers for medical use - Stand-alone gas mixers 1995.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the GMX Series Medical Air/Oxygen Blender (the device) to the Precision Blender (the predicate device). The acceptance criteria are implicitly those of the predicate device, demonstrating that the new device meets or is substantially equivalent to these performance metrics.
| Item | Acceptance Criteria (Predicate Device K053232) | Reported Device Performance (GMX Series Air/Oxygen Blender) |
|---|---|---|
| Oxygen % Range | 21-100% | 21-100% |
| Accuracy | ± 3% | ± 3% |
| Energy Source | Air Supply | Air Supply |
| Supply Pressure | 30-75 Psi | 30-72.5 psi |
| Max Flow (GMX120U-AIR/O2) | ≥120 LPM | ≥120 LPM |
| Pressure Drop (GMX120U-AIR/O2) | ≤6psi at 50Psi inlet pressure and 40lpm flow | ≤6psi at 50Psi inlet pressure and 40lpm flow |
| Alarm/Bypass Reset | ≤6psi | ≤6psi |
| Alarm Intensity | 0.3 meter ≥ 80db | 1 foot ≥ 80db |
| Operating Temperature | 15°C-40°C | 10°C-40°C |
| Connector | NIST or DISS | NIST or DISS |
| Max Flow (GMX30U-AIR/O2) | ≥30 LPM | ≥30 LPM |
| Pressure Drop (GMX30U-AIR/O2) | ≤6psi at 50Psi inlet pressure and 10lpm flow | ≤6psi at 50Psi inlet pressure and 10lpm flow |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical tests based on compliance with voluntary standards (ISO, USP, ASTM, IEC). It does not specify a "test set" in terms of patient data or a specific number of items tested. Instead, it refers to performance testing and final acceptance testing. The data provenance is not explicitly stated as country of origin but implies laboratory testing to meet international and US standards. The study is prospective in the sense that the device was manufactured and then tested against these standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for this device is based on established engineering and medical device performance standards. It doesn't involve clinical evaluations by medical experts to establish a "ground truth" for diagnostic accuracy, but rather verification that the device physically performs as specified and meets safety requirements.
4. Adjudication Method for the Test Set
This information is not applicable. The compliance is determined by meeting the specified values in the standards, not by an adjudication process as would be used in clinical studies.
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
An MRMC comparative effectiveness study was not done. The device is a medical air/oxygen blender, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a physical medical device (an air/oxygen blender), not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. Its performance is inherent to its mechanical and pneumatic design and is tested directly.
7. The Type of Ground Truth Used
The ground truth used is engineering and performance standards, specifically:
- ISO 11195 Gas mixers for medical use – Stand-alone gas mixers 1995
- USP :2012—Particulate Matter in Injections
- ASTM D 5466-01(2007): Standard Test Method for Determination of Volatile Organic Chemicals in Atmospheres (Canister Sampling Methodology)
- IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
- The performance specifications of the legally marketed predicate device (Precision Blender K053232).
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device.
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).