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K Number
K080687
Device Name
SMARTBURS
Manufacturer
S.S. WHITE BURS, INC.
Date Cleared
2008-06-20

(101 days)

Product Code
EJL
Regulation Number
872.3240
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

Smartburs

AI/ML Overview

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.

§ 872.3240 Dental bur.

(a)
Identification. A dental bur is a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. It is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.