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K Number
K201090
Device Name
Structur CAD
Manufacturer
VOCO GmbH
Date Cleared
2020-09-09

(139 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Structur CAD is intended for use for:

  • Temporary bridges spanning up to two pontics
  • Temporary abutment crowns
  • Temporary crowns
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Structur CAD" device does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance characteristics (e.g., accuracy, sensitivity, specificity, or human-in-the-loop performance for an AI/CAD-related device).

This document is a standard FDA clearance letter for a Class II medical device (Temporary Crown and Bridge Resin). It confirms that the device is substantially equivalent to legally marketed predicate devices. The letter primarily addresses:

  • Device Name: Structur CAD
  • Regulation Number and Name: 21 CFR 872.3770, Temporary Crown and Bridge Resin
  • Regulatory Class: Class II
  • Product Code: EBG
  • Date of Clearance: September 9, 2020
  • General Controls: Mentions requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
  • Indications for Use: Temporary bridges spanning up to two pontics, temporary abutment crowns, temporary crowns.
  • Prescription Use: Yes.

The letter explicitly does not include details about:

  1. Acceptance criteria for device performance.
  2. Any performance study results (e.g., sensitivity, specificity, accuracy).
  3. Sample sizes for training or test sets.
  4. Data provenance.
  5. Number or qualifications of experts used for ground truth.
  6. Adjudication methods.
  7. MRMC studies or effect sizes.
  8. Standalone algorithm performance.
  9. Type of ground truth used.
  10. How ground truth was established for training.

The "K201090" number would lead to more detailed submission documents that might contain this information, but this specific letter itself does not. The information provided is standard regulatory clearance language, not a performance study summary.

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.