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The O2asis Personal Oxygen Humidifier is indicated to add moisture and may warm breathing gases for administration to infant, pediatric and adult patients in the home, hospital, and clinical settings. It is used with an external gas source of up to 6 Lpm via nasal cannula.

The O₂asis Personal Oxygen Humidifier is a self-contained, palm-sized, mobile device, making it possible for an individual to move the system to a new location without assistance. The O₂asis Personal OxygenHumidifier provides heat and humidified gas when used with a home oxygen concentrator or cylinder supply with flow rates up to 6 lpm. The subject device humidifies and heats the gas (oxygen) and delivers the warmed gas via a nasal cannula. When unplugged, the subject device provides passive humidification but no heat.

The Perma Pure LLC O2asis Personal Oxygen Humidifier, intended to add moisture and potentially warm breathing gases for patients, underwent various non-clinical testing to demonstrate its performance and substantial equivalence to predicate devices. The information provided heavily focuses on the comparison with predicate and reference devices and a summary of the types of tests conducted rather than a detailed study report with specific acceptance criteria and performance results in a table format.

Based on the provided information, the following can be extracted, acknowledging that detailed performance metrics and acceptance criteria values are largely absent:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Acceptance Criteria" and "Reported Device Performance": The document primarily lists the types of tests performed and broad statements of compliance ("The device meet the applicable performance for the applicable standards" or "The materials were found to meet the applicable endpoints"). Specific quantitative acceptance criteria and detailed performance results are generally not provided in this summary. The table uses predicate device performance as a proxy for implied acceptance criteria where available (e.g., humidification output).

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document describes non-clinical bench testing, biocompatibility testing, and a human factors study, but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature for any data collection). The tests appear to be conducted on the device itself (bench testing) or its components (biocompatibility).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. The testing described is primarily non-clinical (bench, biocompatibility, software V&V, human factors). There is no mention of an expert panel establishing ground truth for a test set in the context of clinical imagery review or similar applications. The "Human Factors / Usability" study mentions a "user population," implying participation from intended users, but details on their qualifications or how "ground truth" was established are absent for this type of test.

4. Adjudication Method for the Test Set

This information is not provided. As the tests are non-clinical and do not involve diagnostic interpretation or multi-reader review, an adjudication method as typically understood in those contexts is not applicable or detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The device is a physical humidifier; its evaluation does not involve diagnostic image interpretation or AI assistance to human readers in a way that an MRMC study would be relevant.

6. If a Standalone (Algorithm Only) Performance Study Was Done

This is not applicable as the O2asis Personal Oxygen Humidifier is a physical medical device, not an algorithm or AI software. Therefore, no standalone algorithm-only performance study was conducted.

7. The Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" is based on adherence to:

• Engineering and Performance Standards: The device's physical performance (e.g., humidification output, temperature, flow rates) is measured against the specifications of relevant ISO and IEC standards.
• Biocompatibility Standards: The materials are tested against endpoints defined in ISO 10993 and ISO 18562 series.
• FDA Guidance Documents: For human factors/usability, the study adheres to FDA guidance, implying that successful completion against the guidance's recommendations constitutes the ground truth for usability.
• Design Specifications: Implicitly, the device's design and functionality are tested against its own pre-defined specifications.

There is no mention of "expert consensus," "pathology," or "outcomes data" as ground truth in the context of this device's evaluation, as these are typically relevant for diagnostic or treatment efficacy studies.

8. The Sample Size for the Training Set

This is not applicable. The O2asis Personal Oxygen Humidifier is a hardware device; it does not involve machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for this device.

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