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The Amron International Treatment Hood is intended to provide a means to administer gas/oxygen/air to a patient by a clinician in clinical multiplace or monoplace chamber systems.

The Amron International Oxygen Treatment Hood, Model 8891, was designed for easy use and cost effective operation within a multiplace or monoplace hyperbaric chamber. The hood assembly is placed over a person's head for treating a person with a gas such as oxygen. The assembly includes a reusable neck ring which fits over a user's head, a tubular latex neck seal with one end connected to the neck ring and the other configured to fit around the user's neck, and a transparent hood fastened to a hood ring that can be sealed against the neck ring. Supply and exhaust tubes direct gas into and out the hood through ports located on the neck ring, The supply and exhaust locations allow oxygen to circulate easily throughout the hood increasing performance while reducing noise levels. Supply gas also helps cool the user reducing potential overheating and continuously defogs the hood's optical window.

The provided text is a 510(k) summary for the Amron International Treatment Hood (K011592) and an FDA clearance letter. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way typically expected for an AI/ML medical device.

This document details the submission of a conventional medical device and focuses on establishing substantial equivalence to a predicate device (Sea-Long Medical Treatment Hood, K010659) through a comparison of technological characteristics. The "studies" mentioned are non-clinical tests run to evaluate performance, not clinical studies involving patient data or AI/ML algorithms.

Therefore, most of the requested information (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, training sets) is not applicable to this type of device and submission.

Here's a breakdown of what can be extracted and why other parts cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document implies that the "acceptance criteria" were essentially demonstrating functional equivalence to the predicate device (Sea-Long Treatment Hood, K010659) across several key performance indicators and technological characteristics. The FDA's clearance indicates that the Amron device "is substantially equivalent" to the predicate.

Reported Device Performance:

Study Proving Acceptance: The study comprised "Non-clinical tests" run for performance at different flow rates and ATA (atmospheres absolute). The conclusion was that the Amron International Treatment Hood "was found to be functionally identical to the Sea-Long Treatment Hood and their technological characteristics are the same."

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

• Sample Size: Not applicable. This was a physical device, and the "tests" were non-clinical performance evaluations, not data-driven tests on a 'test set' of patient data.
• Data Provenance: Not applicable for the same reason.

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

• Not Applicable. Ground truth in the context of AI/ML or diagnostic devices involving expert review is not relevant here. The "ground truth" for this device would be established engineering specifications and performance benchmarks, not expert labels on data.

4. Adjudication method for the test set:

• Not Applicable. No multiple expert review or adjudication process is described for this type of device evaluation.

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:

• No. This is not an AI/ML device, nor one designed to improve human reader performance.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. The "ground truth" for this device is its adherence to design specifications and its functional performance (e.g., maintaining specific oxygen/CO2 levels, flow characteristics, sealing, cooling, noise level) as demonstrated by non-clinical engineering tests, not by expert consensus on biological data or pathology.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

• Not Applicable. No training set exists for this device.

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