FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a US FDA 510(k) clearance letter for a dental ceramic product called "HeraCeram Zirkonia." This letter primarily addresses the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory requirements. It does not contain:

A table of acceptance criteria or reported device performance.
Details about sample sizes for test sets or their data provenance.
Information on experts used to establish ground truth.
Adjudication methods.
Results of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Information about standalone algorithm performance.
The type of ground truth used (e.g., pathology, outcomes data).
Sample sizes for training sets and how their ground truth was established.

These types of details would typically be found in the 510(k) submission itself, which is a much more extensive document than the clearance letter provided. The clearance letter only states that the device was found "substantially equivalent" based on the information in the submission.

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K Number

K040859

Device Name

HERACERAM PRESS

Manufacturer

HERAEUS KULZER, INC.

Date Cleared

2004-05-20

(48 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

HeraCeram Press dental ceramic compound is intended for use with the veneering ceramic material HeraCeram. It can be used for full ceramic restorations with the common layering technique as well as the staining technique. Applications: Veneers, Inlays, Onlays and Crowns.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Heraeus Kulzer, Incorporated, regarding their device "HeraCeram Press." It primarily discusses the substantial equivalence determination for this dental ceramic compound.

This document does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or clinical study results (such as MRMC or standalone performance). The letter is a regulatory approval document and not a performance study report.

Therefore, I cannot fulfill your request for detailed information on acceptance criteria and study particulars based on the provided text.

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K Number

K010416

Device Name

HERACERAM 75

Manufacturer

JELENKO CO.

Date Cleared

2001-03-08

(24 days)