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The BURN-AID Hydrogel, Burn Dressing and Burn Blanket are indicated for single use as a pre-medical first aid for first- and second-degree burns and scalds to cool, soothe and moisturize the burn area.

BURN-AID Hydrogel is a water-based gel containing extract of Melaleuca alternifolia (tea tree oil) and various stabilizers, emulsifiers and preservatives. The tea tree oil acts as an antiseptic. This gel is available in single-use packets for direct application to the skin. The BURN-AID Burn Dressing is composed of a soft foam sheet impregnated with the BURN-AID Hydrogel. The BURN-AID Burn Blanket is composed of pure virgin wool saturated with the BURN-AID Hydrogel.

This document is a 510(k) summary for a medical device called BURN-AID Hydrogel. It describes the device, its intended use, and its comparison to predicate devices. However, it explicitly states "No additional testing necessary" under the "Testing" section.

Therefore, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

It's likely that because this device is being submitted as substantially equivalent to already approved predicate devices (BurnFree Hydrogel and Burnshield Hydrogel), the FDA did not require new performance studies. The 510(k) process often relies on demonstrating substantial equivalence rather than requiring novel clinical trials if the device is similar enough to existing ones.

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The emOx™ device by MedTrak is intended to generate 99% pure oxygen for emergency first aid administration.

The emOx™ device is a lightweight, portable device that produces oxygen of greater than 99% purity by a chemical reaction. The evolved oxygen bubbles pass through a water-filled chamber to humidify the gas on its way to the patient via flexible, ribbed tubing and an open adult or pediatric face mask.

The device, other than the face mask, does not come into contact with the patient. The mask is a currently legally marketed adult or pediatric mask. The oxygen container is constructed of polypropylene. Therefore, the biocompatibility of the materials used is without significance.

This request pertains to the acceptance criteria and supporting studies for a medical device described in a 510(k) premarket notification, not an AI/ML powered device that relies on algorithms and ground truth data. Therefore, many of the questions regarding AI/ML specific details (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth establishment for training) are not applicable to this document.

However, I can extract the relevant information from the provided text regarding the device's acceptance criteria and the tests performed.

Acceptance Criteria and Reported Device Performance for MedTrak International Inc: emOx™

Study Details:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not specify a "test set" in the context of data for an algorithm. Instead, it refers to non-clinical tests performed by independent laboratories on the device itself. Therefore, sample sizes for these tests are not provided, nor is the provenance of "data" in the sense of clinical data. It describes physical testing of the device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This device is not an AI/ML algorithm that requires expert-established ground truth from a dataset. The "ground truth" here is the physical measurement of the device's output (e.g., purity, flow rate) by independent testing laboratories.

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

   • Not applicable for a physical device test. The tests were performed by "independent test laboratories," implying standard scientific measurement and reporting, not expert adjudication of cases.

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:

   • Not applicable. This is not an AI-powered device. No clinical tests were performed as explicitly stated in the document.

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

   • Not applicable. This is not an AI/ML algorithm.

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

   • The "ground truth" for this device's performance is based on direct physical and chemical analytical measurements performed by independent test laboratories (e.g., gas chromatography for purity, flow meters for flow rate, analytical chemistry for contaminants).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML algorithm that requires a training set.

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

   • Not applicable. This is not an AI/ML algorithm that requires a training set.

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