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Finn Chambers AQUA is a patch test delivery system and holding device to place allergens and allergen mixes in contact with the surface of the skin during allergen patch tests. Finn Chambers AQUA patch test chambers are intended for use by, or under the supervision of, a physician for use as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis, photocontact dermatitis and experimental skin testing and allergy protocols.

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This document is a letter from the FDA regarding a change in product code for the "Finn Chambers Aqua" device. It is a reclassification notice and does not contain information about acceptance criteria or performance studies for the device itself.

Therefore, I cannot provide the requested information based on the provided text. The document is administrative in nature and does not describe device performance or testing.

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Allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin

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This is a 510k document for the AllergEAZE™ Patch Test Chambers. This document is a clearance letter from the FDA, not a study report. It states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document. This letter does not describe a clinical study or performance evaluation in the way a scientific paper or a more detailed regulatory submission might.

The document primarily focuses on the regulatory clearance of the device based on substantial equivalence to a predicate, rather than presenting a detailed performance study with acceptance criteria and a study design.

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The SplatrFree Swangle 360 Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient.

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The provided text describes a 510(k) premarket notification for a medical device called the "SplatrFree Swangle 360 Disposable Prophy Angle." This document is a letter from the FDA informing the manufacturer that their device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies related to the device. The document is strictly an FDA clearance letter based on substantial equivalence to a predicate device, which for Class I general controls devices often means the regulatory burden for clinical performance data is minimal or non-existent in the 510(k) submission itself.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document focuses on regulatory clearance, not on a detailed scientific study demonstrating performance against specific criteria.

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