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Allcem Veneer APS is an adhesive luting of ceramic and composite restorations (fabricated at the chair-side or in the laboratory) with a low layer thickness (up to 1.5 mm) that enable the use of a purely light-curing technique due to their high translucency.

Allcem Veneer Try-in accessory is used to simulate the chromatic effect that will be provided when selected the ideal color of Allcem Veneer cement.

Device Description

Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thickness, that do not have opaque infrastructure. The cement is presented as a single component (single svringe) and must be used according to the adhesive cementation technique (acid etching + adhesive).

APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photo initiators that interact among each other amplifying the curing capacity of light emitted from light-curing units.

Presentation Form:

syringe (2,5g) of Allcem Veneer APS cement in shade A1
syringe (2,5q) of Allcem Veneer APS cement in shade A2
syringe (2,5g) of Allcem Veneer APS cement in shade A3
syringe (2,5q) of Allcem Veneer APS cement in shade Trans (Translucent)
syringe (2,5q) of Allcem Veneer APS cement in shade Opaque
syringe (2,5q) of Allcem Veneer APS cement in shade White
syringe (2,5q) of Allcem Veneer APS cement in shades E-Bleach M
syringes (2g) of Try-in

AI/ML Overview

This document is a 510(k) premarket notification for a dental resin material, Allcem Veneer APS. The information provided describes the device's technical characteristics and performance compared to a predicate device (Variolink® Esthetic) to demonstrate substantial equivalence, rather than a clinical study evaluating an AI/ML powered device.

Therefore, many of the requested elements for an AI/ML device study (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or training set details) are not applicable or not provided in this document.

However, I can extract information related to the acceptance criteria for the material properties and the reported performance of the device based on established international standards.

Here's a breakdown of the requested information based on the provided text, focusing on the material's performance:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Specification)	Reported Device Performance (Allcem Veneer APS)	Reported Predicate Performance (Variolink® Esthetic)
Film Thickness	≤ 50 µm (and not 10 µm above manufacturer's declared value if declared, but wasn't for Allcem Veneer APS) - ISO 4049	Average: 11.8 µm (Samples: 17, 15, 13, 9, 5 µm)	Average: 22.0 µm (Samples: 25, 18, 27, 20, 20 µm)
Stability of Tone and Color	No more than a small change in color; visual inspection by three observers with normal vision, identifying no differences - ISO 4049	All comparisons by three observers with normal eyesight showed no color difference.	Observers attest no difference of color (implied to meet criteria).
Flexural Strength	≥ 50 MPa - EN ISO 4049	110.90 MPa	91.84 MPa
Depth of Cure	> 1.0 mm for opaque materials; > 1.5 mm for non-opaque materials - ISO 4049	All results were greater than specified threshold (e.g., 2.19 mm reported in comparison; detailed CP results not provided for Allcem Veneer APS in table).	1.62 mm (reported in comparison table)
Radiopacity	≥ 1 mm (aluminum equivalent for 1.0 mm thick specimen); not 0.5 mm above manufacturer's declared value if declared - ISO 4049 (material must be radiopaque if declared)	2.47 mm	2.36 mm
Sensitivity to Environment Lighting	Physical homogeneity of the sample (no difference after test compared to unexposed sample) - ISO 4049	Superior to the acceptance criteria (> 60 sec).	Superior to the acceptance criteria (implied to meet).
Water Sorption and Solubility	Sorption: ≤ 40 µg/mm³; Solubility: ≤ 7.5 µg/mm³ - EN ISO 4049	Sorption: 24.46 µg/mm³; Solubility: 6.17 µg/mm³	Sorption: 25.61 µg/mm³; Solubility: 5.27 µg/mm³
Accelerated Stability Studies	Confirm 2-year shelf-life at 25 °C.	2-year shelf-life at 25 °C confirmed based on 129 days of testing.	Not applicable (device under evaluation).
Long-Term Stability (Shelf) Report	Verify physical and chemical characteristics over expected shelf life.	Maintains properties for 2 years in indicated storage condition.	Not applicable (device under evaluation).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not explicitly state the total number of samples or specimens used for each test. For Film Thickness, 5 samples were listed for both Allcem Veneer APS and Variolink. Other tests refer to "results" or "specimens" without specific counts.
Data Provenance: The studies were conducted by the manufacturer, Dentscare Ltda, based in Brazil (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL). The studies are non-clinical (laboratory-based) performance tests, not retrospective or prospective clinical data from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

For the "Stability of tone and color" test, three observers with normal vision, certified by a competent physician, were used for visual inspection.
For other tests, the "ground truth" is defined by the ISO 4049 standard and measured by laboratory equipment, not human experts.

4. Adjudication Method for the Test Set:

For the "Stability of tone and color" test, the judgment was based on consensus (implicitly, as "no color difference... attested" by all three observers).
For other material property tests, adjudication methods are not applicable as they are objective laboratory measurements against a standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This document pertains to the
substantial equivalence of a dental resin material based on mechanical and chemical properties, not a reader-dependent diagnostic AI/ML device.

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

Not applicable. This device is a dental material, not an algorithm. The performance tests are for the material itself.

7. The type of ground truth used:

The "ground truth" for the device's performance is established by objective measurements against the specifications outlined in international standards, primarily ISO 4049 (Dentistry Polymer-based restorative materials) and ISO 10993-1 (Biological evaluation of medical devices). For color stability, it's expert consensus (three observers).

8. The sample size for the training set:

Not applicable. This is a physical dental material, not an AI/ML model, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, this question is irrelevant.

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