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K Number
K022653
Device Name
ELITE MONOPHASE
Manufacturer
ZHERMACK S.P.A.
Date Cleared
2002-10-28

(80 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Zhermack Elite Monophase is a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.

Device Description

ELITE MONOPHASE Tray Material/ Maxi Tray Material, Medium Viscosity/ Maxi Monophase, Low Viscosity

AI/ML Overview

This is a letter from the FDA regarding the 510(k) premarket notification for the ELITE MONOPHASE Tray Material/Maxi Tray Material, Medium Viscosity/Maxi Monophase, Low Viscosity impression materials. This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the way described in the prompt's request (e.g., performance metrics, sample sizes, expert ground truth, etc.). This document is an FDA clearance letter, which means the manufacturer submitted data (likely including performance data, but not detailed here) to the FDA to demonstrate substantial equivalence, and the FDA agreed.

Therefore, I cannot provide the requested table and study details based on the provided text. The letter only gives regulatory information and general indications for use.

To answer your prompt directly based on the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the provided FDA letter. The letter confirms substantial equivalence but does not detail specific performance criteria or results.
  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available in the provided text.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is an impression material, not an AI-assisted diagnostic device for human readers.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is an impression material, not an algorithm.
  7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available in the provided text.
  8. The sample size for the training set: Not applicable, as this is an impression material, not an AI model requiring a training set.
  9. How the ground truth for the training set was established: Not applicable, as this is an impression material, not an AI model.

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).