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The Tenacore Oxygen Blender, is intended for non-invasive mixing and delivery of a ratio of therapeutic oxygen and medical grade air as a stand-alone unit or as a component of a respiratory support apparatus.

The Tenacore Oxygen Blender is typically a wall-mounted unit that provides inlets for medical grade air and therapeutic oxygen. The percentage of oxygen to air can be adjusted from 21-100%.

The Tenacore Oxygen Blender is intended for non-invasive mixing and delivery of a ratio of therapeutic oxygen and medical grade air as a stand-alone unit or as a component of a respiratory support apparatus.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not applicable as the study described is a performance test for a medical device's physical specifications (accuracy) and not an evaluation based on expert interpretation of data like medical images.

4. Adjudication Method for the Test Set

This information is not applicable for the type of performance testing described. Adjudication typically refers to resolving discrepancies between multiple expert interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The study focuses on the device's technical performance, not on human-in-the-loop improvements with AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The "Performance Data & Conclusions" section indicates that "Performance testing was conducted as required by standards," which refers to the device itself meeting specified technical standards like accuracy.

7. Type of Ground Truth Used

The ground truth used was based on established engineering and medical device standards for oxygen blenders. Specifically, the device was tested against standards such as EN ISO 15001:2004, 60601-1, 9703-3:1998, 601-1:1988, and IEC 79-4:1975 to verify its accuracy and other performance parameters.

8. Sample Size for the Training Set

This information is not applicable. The device is a mechanical oxygen blender, not an AI/machine learning model 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.

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