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The emOx device is intended to generate oxygen of greater than 99.7% purity for emergency first aid administration.

emOx Portable Oxygen Generator

The provided document is a 510(k) clearance letter from the FDA for a device called "emOx Portable Oxygen Generator" (K984081). It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed information requested regarding acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance letter typically references that such information was provided by the manufacturer in their submission, but it does not reproduce the full study report or acceptance criteria within the letter itself. The letter focuses on the FDA's determination of substantial equivalence based on the submitted data.

Therefore, I cannot fulfill your request with the provided text. The requested information about acceptance criteria, study details, sample sizes, and ground truth would be found in the original 510(k) submission documentation, which is not included in this letter.

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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.

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This document is a 510(k) clearance letter from the FDA for a medical device called "Burn-aid Hydrogel, Burn-aid Dressing, Burn-aid Burn Blanket". It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

Therefore, I cannot fulfill your request for the specific details you asked for, such as:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (algorithm only) study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on the regulatory clearance process, defining the permissible indications for use and outlining limitations on labeling claims to ensure substantial equivalence with existing products. It mentions "general controls provisions of the Act" and "Good Manufacturing Practices (GMP)" but does not detail performance-based acceptance criteria or validation studies beyond the substantial equivalence determination.

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