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To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.

The Oralgiene Tongue Cleaner is a "T" shaped manual device used in the same manner as other items already in the marketplace. It is all in one piece and has mild ridges, but no sharp edges. It is composed of a durable and safe plastic.

The provided 510(k) summary for the Oralgiene Tongue Cleaner does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a premarket notification for a medical device (tongue cleaner) and primarily focuses on demonstrating substantial equivalence to predicate devices already on the market. This type of submission relies on comparing the new device's features and intended use to those of previously cleared devices, rather than presenting new performance data against defined acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and studies from the given input.

Here's what the document does provide:

• Intended Use: "The Oralgiene Tongue Cleaner is intended to be used to remove plaque and food debris from the surface of the tongue. The device is normally used in conjunction with cleaning the teeth and serves a purpose similar to brushing the tongue. Promotes a clean mouth and fresher breath."
• Predicate Devices: Tongue Klean (K973175) and Breath-So-Fresh Tongue Cleaner (K972644). The clearance of the Oralgiene Tongue Cleaner is based on its substantial equivalence to these predicate devices.

To answer your request, a different type of document (e.g., a clinical study report or a design verification report) would be needed.

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