LogoFDA 510(k) Search
K Number
K180386
Device Name
Meron Plus QM
Manufacturer
Voco GmbH
Date Cleared
2018-05-08

(85 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Cementation of: - metal-based inlays, onlays, crowns and bridges - high-strength (zirconia-based) all-ceramic crowns and bridges - metal, ceramic and fiber posts - high strength all ceramic inlays i - । resin inlays, onlays, crowns and bridges

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) clearance letter for "Meron Plus OM" does not contain any information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

The document is a standard clearance letter for a dental cement, outlining its classification, predicate device, and intended uses. It primarily addresses regulatory aspects, not performance studies of an AI/ML system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device performance using the provided text.

To answer your question, I would need a document related to the clearance of an AI/ML-driven medical device, which would typically include details about:

  • Performance metrics: Specific thresholds for accuracy, sensitivity, specificity, AUC, F1-score, etc.
  • Study design: Prospective/retrospective, sample size, data source.
  • Ground truth establishment: How the "truth" was determined for the test cases (e.g., expert consensus, pathology, clinical outcomes).
  • Expert qualifications and adjudication: Details about the radiologists/clinicians involved.
  • Human-in-the-loop studies (MRMC): If applicable, how AI assistance improved human performance.
  • Stand-alone performance: Algorithm-only results.
  • Training data details: Size and ground truth establishment for the training set.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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 § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.