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K Number
K024034
Device Name
OCCLUFAST ROCK
Manufacturer
ZHERMACK S.P.A.
Date Cleared
2002-12-18

(12 days)

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

Zher mack OCCLUFAST ROCK 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.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a dental impression material, Occlufast Rock. The document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. This type of document does not typically contain detailed study data, acceptance criteria, or performance metrics in the way a clinical trial report or a performance study summary for an AI/ML device would.

Therefore, most of the requested information cannot be extracted from the provided text. The document confirms that the device is an "Impression Material" (Regulation Number: 872.3660, Regulation Name: Impression Material, Regulatory Class: II, Product Code: ELW). Its intended use 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."

Here's a breakdown of what can and cannot be answered based only on the provided text:

  1. A table of acceptance criteria and the reported device performance:

    • Cannot be provided. The document is a regulatory approval letter based on substantial equivalence, not a performance study report. It does not list specific acceptance criteria or reported performance values.

  2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • Cannot be provided. This information is absent from the regulatory approval letter.

  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):

    • Cannot be provided. This information is absent from the regulatory approval letter. The "ground truth" for a dental impression material would likely relate to its physical properties (dimensional stability, accuracy, tear strength, etc.) and clinical performance, not expert image interpretation.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Cannot be provided. This information is absent from the regulatory approval letter.

  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:

    • Cannot be provided. This is not an AI/ML device, and therefore MRMC studies for AI assistance are not relevant. The device is a traditional dental impression material.

  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

    • Cannot be provided. This is not an AI/ML device.

  7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

    • Cannot be provided definitively from this document. While not explicitly stated, for an impression material, the "ground truth" for its performance would likely involve objective measurements of physical properties (e.g., dimensional accuracy, setting time, tear resistance) and possibly clinical evaluations of impression quality, rather than expert consensus on diagnostic images or pathology. The document only states it's intended "to reproduce the structure of a patient's teeth and gums," implying the ground truth would be the actual tooth and gum structure it needs to replicate accurately.

  8. The sample size for the training set:

    • Cannot be provided. This is not an AI/ML device, so there is no "training set."

  9. How the ground truth for the training set was established:

    • Cannot be provided. This is not an AI/ML device, so there is no "training set."

§ 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).