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After primary access using another instrument, Smartburs is intended to selectively remove decayed dentin, without removal of healthy dentin from tooth surfaces. Smartburs is not designed to cut or remove enamel, composite, amalgam, cementum, or healthy dentin.

Smartburs

This document is a 510(k) premarket notification letter from the FDA for a dental device called "Smartburs". It confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving device performance as typically expected for complex AI/ML-based medical devices.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria or Performance Study: The provided text is a regulatory clearance letter, not a scientific study report. It states that the device is substantially equivalent to a predicate device, which is a regulatory determination, not a performance validation against specific acceptance criteria.
• Device Type: "Smartburs" is a dental bur, a mechanical instrument for removing decay. It is not an AI/ML-based device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance, nor would it involve training sets, test sets, or expert adjudication for ground truth.

Because the document does not contain the specifics of a performance study for an AI/ML device, I cannot fill in the requested table or answer the questions regarding sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

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