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The O2PAK™ Portable Oxygen Generator, Model P26029 is intended to provide oxygen for emergency use; the O2PAK™ is currently offered to be used under the Direction of trained medical military personnel in support for disaster relief, crisis response, wartime operations, deterrence and contingency operations, humanitarian relief situations or peacetime engagements.

The O2PAK™ is designed to be compact, lightweight, portable, durable and easy to carry for emergency use. O2PAK™ Model P26029 is the only O2PAK™ model currently available. Its principle of operation is the same as standard chemical oxygen generators. Oxygen is administered to the patient through a nasal cannula or an equivalent device.

Here's a breakdown of the acceptance criteria and study information for the O2PAK™ Portable Oxygen Generator, Model P26029, based on the provided document.

Acceptance Criteria and Device Performance

Study Information

The document describes performance testing of the O2PAK™ Portable Oxygen Generator against various engineering and environmental standards. It does not describe a clinical study involving human patients or ground truth established by experts for diagnostic or treatment purposes.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: For the Shock test (MIL-STD-810G METHOD 516.6), 2 test articles were used, each subjected to 13 drops (total 26 drops). For other tests (Vibration, O2 Outlet Temperature, O2 Purity, O2 Flow, Outlet Pressure, High Temperature, Low Temperature, Humidity), the document states "Test; measured on all test articles" or "Test," implying testing was conducted on an unspecified number of test articles, but it does not provide an exact sample count beyond the shock test.
   • Data Provenance: The document implies these were prospective engineering and environmental tests conducted by or for Pacific Precision Products. The country of origin of the data is not explicitly stated but is implicitly within the context of a US-based regulatory submission (510(k)).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This device is an oxygen generator, and its performance is evaluated against engineering specifications and industry standards rather than a "ground truth" derived from expert clinical opinion, as would be the case for a diagnostic medical device. The "ground truth" here is the established pass/fail criteria of the specified standards (e.g., ASTM F1464-93, MIL-STD-810G, IEC 60068-2-6, RTCA / DO-160G).

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • None. Adjudication methods are typically used in studies where human readers interpret data (e.g., medical images) and their assessments need to be reconciled to establish a consensus ground truth. This is not relevant for the described engineering performance tests.

4. 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:

   • No. An MRMC comparative effectiveness study is not mentioned as this device is not an AI-powered diagnostic tool. The document focuses on the physical and functional performance of the oxygen generator itself.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This device is a piece of medical equipment, not an algorithm. The testing described is for the physical device's performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the performance tests described consists of the specified pass/fail criteria within the referenced industry standards (e.g., MIL-STD-810G, IEC 60068-2-6, ASTM F1464-93, RTCA / DO-160G). These standards define acceptable ranges for physical properties, temperature, flow rates, purity, etc.

7. The sample size for the training set:

   • Not Applicable. There is no mention of a training set as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set for ground truth was established for this type of device and testing.

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