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1. For first aid use on minor burns including sunburn, cuts, scrapes, and abrasions.
2. Relieves Pain.
3. Cools and Soothes.
4. Moistens.
5. Non-Irritating
6. Bacteriostatic

BURNFREE PAIN RELIEVING GEL

I'm sorry, but this document contains a letter from the FDA regarding a 510(k) premarket notification for "Burnfree Sterile Wound and Burn Dressing," "Burnfree 1/8 oz. Sterile Pain Relieving Gel," and "Burnfree Pain Relieving Gel."

This document does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot provide a description of the acceptance criteria and the study that proves the device meets them based on the provided text.

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1. For first aid use on minor burns including sunburn, cuts, scrapes, and abrasions.
2. Relieves Pain.
3. Cools and Soothes.
4. Moistens.
5. Non-Irritating
6. Bacteriostatic

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Burnfree Sterile Wound and Burn Dressing" and "Burnfree Pain Relieving Gel" products. It confirms that the devices are substantially equivalent to previously marketed devices and outlines regulatory responsibilities.

This document does not contain information about:

1. Acceptance criteria and reported device performance.
2. Sample sizes, data provenance, or details of a study.
3. Number of experts, their qualifications, or adjudication methods.
4. Multi-reader multi-case (MRMC) comparative effectiveness studies.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study details based on the provided text.

Ask a specific question about this device

1. First aid for burns, scalds, cuts, and abrasions.
2. Relieves Pain.
3. Cools and Soothes.
4. Moistens.
5. Non-Adherent
6. Bacteriostatic

Not Found

This looks like a 510(k) clearance letter for a medical device from 1999, specifically for "Burnfree Sterile Wound and Burn Dressing," "Burnfree 1/8 oz. Sterile Pain Relieving Gel," and "Burnfree Pain Relieving Gel."

Unfortunately, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

This type of FDA letter (a 510(k) clearance) focuses on demonstrating "substantial equivalence" to a predicate device already on the market. It doesn't typically require the submission of new clinical trial data or detailed performance studies with acceptance criteria in the same way a Premarket Approval (PMA) would.

Therefore, I cannot provide the requested information from this document. The document primarily states:

• The devices are substantially equivalent to pre-amendments devices.
• The indications for use for the Burnfree Sterile Burn and Wound Dressing (e.g., first aid for burns, relieves pain, cools and soothes, moistens, non-adherent, bacteriostatic).
• General regulatory information.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (for a PMA or a more recent 510(k) that might include performance data), or a full study report.

Ask a specific question about this device