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K Number
K043462
Device Name
CZR PRESS LF
Manufacturer
NORITAKE CO., INC.
Date Cleared
2005-01-11

(27 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use in prosthetic dentistry to create an all-ceramic prosthesis

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) K043462 document for "CZR Press LF" porcelain powder does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a clearance letter from the FDA indicating that the device has been found substantially equivalent to a legally marketed predicate device. This type of FDA clearance does not typically include detailed performance study results or explicit acceptance criteria. Instead, it relies on demonstrating that the new device is as safe and effective as an existing, cleared device.

Therefore, I cannot fulfill your request for the following sections based on the provided text:

  1. A table of acceptance criteria and the reported device performance: Not present in the document.
  2. Sample size used for the test set and the data provenance: Not present in the document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in the document.
  4. Adjudication method: Not present in the document.
  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 not an AI/diagnostic device. The document does not mention any MRMC studies or AI.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/diagnostic device.
  7. The type of ground truth used: Not present in the document.
  8. The sample size for the training set: Not applicable as this is not a device typically requiring a "training set" in the machine learning sense.
  9. How the ground truth for the training set was established: Not applicable.

The document primarily states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed devices marketed in interstate commerce prior to May 28, 1976... and that therefore, market the device, subject to the general controls provisions of the Act."

For devices like porcelain powder, substantial equivalence is often demonstrated through material characterization, biocompatibility testing (if applicable), and comparison to the physical and chemical properties of predicate devices, rather than large-scale clinical performance studies as would be seen for diagnostic or AI-powered devices. These details are not within this specific FDA letter.

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.