(88 days)
The Innosan Travelair® "S" Portable Oxygen Concentrator is a mobile oxygen concentrator for use in an automobile, with power from the automobile's battery, intended to provide a patient with supplemental oxygen. This device delivers oxygen to patients by physical means, using a molecular sieve bed oxygen concentrator and is designed to conserve the use of oxygen during such delivery.
The Travelair® is a mobile oxygen concentrator intended for use in an automobile, with power from the automobile's battery. The Travelair® uses two molecular sieves to extract oxygen from ambient air; this is similar to most domestic oxygen concentrators. The unit provides two switch-selectable operating modes, continuous and demand, with a nonadjustable flow of approximately 1.2 L/min continuous and approximately 2.6 L/min in the demand mode. The unit has two large wheels, one small caster, and an adjustable handle to provide maneuverability. It has a hinged cover across the top panel to protect against the entry of fluids. An alarm warns of low oxygen concentration, excessive internal temperature, blocked air inlet filter, and loss of power.
This is a 510(k) summary for a medical device called the "Innosan Travelair® 'S' Portable Oxygen Concentrator." This document is focused on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It does not describe a study involving AI performance, human readers, or image analysis, as the device is an oxygen concentrator.
Therefore, many of the requested elements of your prompt are not applicable to the information provided in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table format alongside performance metrics for the oxygen concentrator. Instead, it refers to general compliance with established standards and guidance.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND (Electrical, Mechanical and Environmental Performance Requirements) | "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was CITECH's conclusion that the Travelair® sample tested met all relevant requirements of the aforementioned test." (Implies compliance across: Input Voltage Variation, Overcurrent Protection, Controls Protection, Connector Protective Incompatibility, Mechanical Safety, Mechanical Vibration and Shock Resistance, Fluid Spill Resistance, Extreme Operating and Storage Temperature/Humidity, Surface Temperatures) |
| Compliance with IEC-601-1 (1988), Clause 44.6 | Met requirements (Fluid Spill Resistance) |
| Compliance with ASTM F1464-93, "Standard Specification for Oxygen Concentrators for Domiciliary Use" | Met requirements. |
| Compliance with FDA's Reviewer Guidance for Oxygen Concentrators (1991) | Adhered to the guidance. |
| Radiated and Conducted Electromagnetic Energy and Magnetic Field Testing (per DCRND Reviewer's Guideline, November 1993) | Testing was conducted and presumably met the guidelines, as no violations or safety hazards were reported. |
2. Sample size used for the test set and the data provenance
The document states, "It was CITECH's conclusion that the Travelair® sample tested met all relevant requirements..." This implies that at least one physical unit of the Innosan Travelair® "S" Portable Oxygen Concentrator was used for testing. The exact number of units tested (sample size) is not specified beyond "sample."
- Test Sample Size: Not explicitly stated, implied to be at least one physical "sample" of the device.
- Data Provenance: The testing was conducted by CITECH, presumably in a laboratory setting, to evaluate the physical device's performance against engineering and safety standards. This is prospective testing of a physical device, not retrospective analysis of data. Country of origin not specified for CITECH or the testing location, but the submitter is from Italy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable here. Ground truth, in the context of this device, refers to the objective performance against engineering and safety standards. This is established through direct measurement and testing methods specified in the standards (e.g., measuring voltage, oxygen concentration, temperature, vibration resistance). The "experts" would be the engineers and technicians at CITECH performing the tests, whose qualifications are in their ability to conduct these specific tests accurately and interpret the results against the cited standards. Their number and specific qualifications are not detailed.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's disagreement among human readers/interpreters of complex data (e.g., medical images). For physical device testing against objective standards, the outcome is typically a direct measurement or a pass/fail against a specific threshold.
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
Not applicable. This device is an oxygen concentrator, not an AI-powered diagnostic tool, and no human readers or AI assistance are involved in its primary function or testing as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to AI algorithm performance. Not applicable to this oxygen concentrator.
7. The type of ground truth used
The ground truth used is the objective outcome of physical device performance against established engineering, electrical, mechanical, and environmental standards. This includes:
- Measurements of electrical parameters (voltage, current).
- Measurements of mechanical robustness (vibration, shock, fluid spill resistance).
- Measurements of environmental tolerance (temperature, humidity).
- Measurements related to electromagnetic compatibility.
- Measurements of oxygen concentration and flow rates (implied by compliance with ASTM F1464-93 for oxygen concentrators).
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).