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K Number
K060330
Device Name
SEE-IT CARIES DETECTOR
Manufacturer
RONVIG DENTAL MFG. A/S
Date Cleared
2006-04-07

(57 days)

Product Code
LFC
Regulation Number
872.1740
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A visual aid for the identification of infected carious dentine.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed study information needed to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the SEE-IT™ Caries Detector, stating that the device is substantially equivalent to a legally marketed predicate device.

The letter mentions the device's regulation number, regulation name, regulatory class, and product code, but it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details about sample sizes, data provenance, ground truth establishment, or expert qualifications.
  3. Information on adjudication methods or multi-reader multi-case (MRMC) studies.
  4. Data regarding standalone algorithm performance.
  5. Training set details.

Therefore, I cannot fulfill your request for these specific details based on the provided text.

§ 872.1740 Caries detection device.

(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.