K Number
K050203
Device Name
ALLUX
Date Cleared
2005-02-14

(17 days)

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

Allux® is a dental silicate-glass ceramic that can be used by dental technicians to fabricate all-ceramic restorations by veneering aluminium oxide (Al₂O₃) frameworks.

The coefficient of thermal expansion [CTE (25 - 500°C)] of these aluminium oxide (Al₂O₃) frameworks had to equal approximately 8.0 x 10˚K¹ .

Device Description

Allux® is a dental porcelain system that consists of 127 different ceramic powders.

It is intended to be used by professional dental technicians to manufacture all-ceramic dental appliances for the sole use of particular patients.

Allux® is recommended for veneering alumina oxide (Al₂O₃) frameworks, in which it provides an easy to use dental restorative material to fabricate dental restorations with the best possible aesthetic results.

The coefficient of thermal expansion [CTE (Algos) of these alumina oxide (Al₂O ) frameworks had to be approximately 8 x 10 ° K ¹.

Allux meets all applicable requirements of the standard ISO 6872: 1995 "Dental ceramic".

AI/ML Overview

The provided text is a 510(k) summary for a dental porcelain system called Allux. It describes the device, its intended use, and its classification, but it does not contain a study or data proving the device meets specific acceptance criteria in the way a typical medical device study would.

Instead, the submission states that "Allux meets all applicable requirements of the standard ISO 6872: 1995 'Dental ceramic'". This implies that the acceptance criteria are defined by this international standard for dental ceramics, and the device has been tested against these criteria.

Therefore, many of the requested details about a study, such as sample size, data provenance, expert adjudication, MRMC studies, or specific ground truth methodologies, are not present in this type of regulatory submission. These details would typically be found in a more detailed testing report or clinical study, which are not included in this 510(k) summary.

Here's an attempt to answer the questions based only on the provided text, acknowledging where information is missing:

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

The acceptance criteria are implicitly defined by ISO 6872: 1995 "Dental ceramic". The document states that "Allux meets all applicable requirements" of this standard. Without the standard itself, specific numerical acceptance criteria cannot be listed.

Acceptance Criteria (Defined by ISO 6872: 1995 "Dental ceramic")Reported Device Performance
Specific criteria from ISO 6872: 1995 (e.g., flexural strength, chemical solubility, thermal expansion compatibility, aesthetics, etc.)Meets all applicable requirements of ISO 6872: 1995

Note: The actual numerical criteria would need to be extracted from the ISO 6872: 1995 standard itself, which is not provided here.

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

This information is not provided in the 510(k) summary. The document does not detail the specific testing methodologies or the data collected to demonstrate compliance with ISO 6872.

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)

This information is not provided. Given that the compliance is with an international standard for material properties, "expert ground truth" in the clinical sense is not directly applicable here. The "ground truth" would be the measured physical properties of the ceramic, compared against the standard's specifications.

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

This information is not provided. Adjudication methods are typically used in clinical studies involving interpretation, which is not the primary focus of demonstrating compliance with a material properties standard.

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

An MRMC comparative effectiveness study is not applicable and was not done as described in this document. This typically applies to AI-assisted diagnostic devices. The Allux system is a dental porcelain material, not an AI diagnostic tool.

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

This question is not applicable to this device. The Allux system is a dental porcelain material, not an algorithm.

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

The "ground truth" for this device's performance would be the measured physical and chemical properties of the Allux ceramic powders and fabricated restorations, as defined and tested according to the methodologies outlined in ISO 6872: 1995. This is typically determined through laboratory testing rather than clinical expert consensus or pathology in the traditional sense.

8. The sample size for the training set

This information is not applicable and not provided. The Allux system is a material, not a machine learning algorithm that requires a "training set."

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

This question is not applicable as there is no "training set" for this material device.

§ 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.