(316 days)
The Inogen At Home Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen At Home Oxygen Concentrator may be used in a home or institution.
The Inogen At Home is a stationary concentrator providing approximately 90% oxygen to patients on a continuous flow basis at a rate of 1.0 liter per minute (LPM) to 5.0 liters per minute (LPM), in 1.0 liter per minute (LPM) increments. Nasal cannula channels oxygen from device to patient; both concentrator and nasal cannula are non-sterile. The device is capable of continuous use in the home or in an institutional setting. The Inogen At Home can be powered by mains AC power found in the home or in an institutional setting. The Inogen At Home includes a detachable AC power cord to make the electrical connection to the AC mains. The Inogen At Home utilizes Pressure Swing Adsorption (PSA) technology to produce oxygen. Oxygen is separated from ambient air under pressure by molecular characteristics and affinity for adsorbent material. The molecular sieve preferentially adsorbs nitrogen, allowing enriched oxygen to collect in an accumulator; the process then swings to low pressure to desorb the nitrogen, exhausting it back into the environment. A series of sieve beds, manifold with precision valves, sensors, and embedded software are used collectively to govern system functionality.
The provided document describes the Inogen At Home Oxygen Concentrator, a medical device for supplemental oxygen delivery. It includes details about its purpose, technological characteristics, and conformance to relevant standards. However, the document does not contain a study that validates the device against specific acceptance criteria in the format requested.
Here's an analysis based on the information provided in the document, highlighting what is missing for a complete answer to your request:
The document clearly states the device's conformance to several international and national standards (EN ISO 8359:2012, ASTM F 1464:2005, IEC 60601-1). It also lists "performance testing" that was done, but does not provide specific acceptance criteria for these tests or the reported performance data in a quantitative table.
Here's a breakdown of what can and cannot be answered based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria Mentioned (Implicitly by conformance to standards or general tests):
- Oxygen Concentration: Approximately 90% (This is a design spec, not explicitly an "acceptance criterion" from a study).
- Flow Rate: 1.0 to 5.0 LPM in 1.0 LPM increments (Design spec).
- Electrical Safety/Compatibility: Conformance to IEC 60601-1.
- Software Functionality: Tested.
- Fire Mitigation: Tested.
- Noise, Temperature, and Altitude Ranges: Tested.
- Outlet Pressure: Tested.
- Flow Indicator Accuracy: Tested.
- Particulate Matter, Ozone, Volatile Organic Compounds, Carbon Dioxide, Carbon Monoxide: Biocompatibility testing included evaluation of these.
- Overall safety requirements per EN ISO 8359:2012 and ASTM F 1464:2005.
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Reported Device Performance: The document states that "Performance testing included the assessment of electrical safety/ compatibility, software functionality, fire mitigation and noise, temperature and altitude ranges, outlet pressure, flow indicator accuracy, and oxygen concentration." It also mentions "Biocompatibility testing included the evaluation of particulate matter, Ozone, Volatile Organic Compounds, Carbon Dioxide, and Carbon Monoxide." However, no specific quantitative results or performance data against numerical acceptance criteria are provided in the text. For example, it doesn't say "oxygen concentration met specific criteria of X% +/- Y%" or "noise levels were Z dB below threshold."
Therefore, a table cannot be fully constructed with specific quantitative acceptance criteria or reported performance from this document.
Regarding the study that proves the device meets the acceptance criteria:
The document describes "Non-clinical Performance Data" and "Performance testing" as well as "Biocompatibility testing." These are the studies mentioned. However, the details required for points 2-9 are not present in the provided text.
Missing Information:
- 2. Sample sized used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device testing. "Ground truth" in this context would be objective measurements from calibrated equipment, not expert consensus interpretation.
- 4. Adjudication method for the test set: Not applicable.
- 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 is not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical oxygen concentrator, not an algorithm.
- 7. The type of ground truth used: For performance tests, the ground truth would be objective measurements from calibrated sensors and analytical equipment (e.g., oxygen analyzers, flow meters, pressure gauges, sound level meters, gas chromatographs for impurities). For biocompatibility, it would be analytical results against established safe limits. This is implied by the testing, but not explicitly detailed.
- 8. The sample size for the training set: Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
Summary:
The provided text serves as a 510(k) summary for a medical device (oxygen concentrator). It broadly discusses performance and biocompatibility testing and conformance to standards to demonstrate "substantial equivalence" to predicate devices. However, it does not detail a specific quantitative study with acceptance criteria and results in the manner typically expected for AI/diagnostic devices as implied by your questions, which are more tailored to software-based systems or image analysis. The "acceptance criteria" here are largely defined by compliance with the cited medical device standards (EN ISO 8359, ASTM F 1464, IEC 60601-1) and internal design specifications.
§ 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).