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The intended use of the Balloon Goggle is to help the endoscope with being inserted into the gastrointestinal tract with or without the aid of gas (air or CO2) insufflation.

Concentric Balloon Goggle

I am sorry, but the provided text from the FDA letter (K112698) does not contain information about acceptance criteria or a study proving device performance for the "Concentric Balloon Goggle." The document is a 510(k) substantial equivalence letter, which states that the device is substantially equivalent to legally marketed predicate devices.

This type of letter primarily focuses on:

• Confirmation of Substantial Equivalence: It asserts that the device (Concentric Balloon Goggle) is substantially equivalent to pre-existing, legally marketed devices.
• Regulatory Classification: It specifies the regulation number, name, and regulatory class (Class II) for the device.
• General Controls: It reminds the applicant of their obligations regarding general controls, such as annual registration, listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
• Indications for Use: It includes an "Indications for Use" statement, which describes the intended purpose of the device: "The intended use of the Balloon Goggle is to help the endoscope with being inserted into the gastrointestinal tract with or without the aid of gas (air or CO2) insufflation."

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications from this document. This information would typically be found in a separate submission report, such as a validation study report, that supports the 510(k) application, but it is not part of this FDA clearance letter.

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