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K Number
K030916
Device Name
UFI GEL HARD C
Manufacturer
VOCO GMBH
Date Cleared
2003-06-19

(87 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
K111177
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Hard permanent total or partial relinings to restore the functions of partial or complete dentures Lengthening of denture margins

Device Description

Not Found

AI/ML Overview

Unfortunately, the provided document is a 510(k) clearance letter for the Ufi Gel Hard C, a denture relining resin. This type of document does not contain the detailed information required to fulfill your request about acceptance criteria and a study proving a device meets them.

The 510(k) process primarily demonstrates substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific performance metrics and rigorous statistical analysis as would be found in a PMA (Pre-Market Approval) application or a more detailed study report.

Therefore, I cannot provide the following information based on the given text:

  1. A table of acceptance criteria and the reported device performance: This document doesn't specify acceptance criteria for performance metrics or present any performance data in this format.
  2. Sample size used for the test set and the data provenance: No test set information is present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on expert review for a test set.
  4. Adjudication method for the test set: Not applicable as there's no test set described.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is a material (denture resin), not an AI device, so MRMC studies and AI assistance are not relevant.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a denture resin.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as performance data is not detailed.
  8. The sample size for the training set: Not applicable as this is not an AI/software device with a training set.
  9. How the ground truth for the training set was established: Not applicable.

To get this type of information, you would typically need a much more comprehensive study report, a PMA application, or a detailed scientific publication about a novel medical device, particularly for software or AI-driven diagnostics/therapeutics.

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.