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The ATD AUTOMATIC BRIDGE REMOVER device is indicated for use in the removal of dental crowns and bridges.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called the "ATD Automatic Bridge Remover." This letter indicates that the device has been deemed substantially equivalent to a predicate device already on the market.

However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study details requested in your prompt.

The 510(k) clearance process focuses on substantial equivalence to existing devices rather than requiring new clinical trials or detailed performance studies like those described in your prompt for AI/diagnostic devices.

Therefore, I cannot fulfill your request with the provided information. To get the details you're asking for, you would typically need to consult a different type of regulatory submission (e.g., a PMA application for high-risk devices) or technical documentation that would accompany such a device, often found on the manufacturer's website or in scientific publications.

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