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AIGIS-PLUS is intended for manufacturing

• Inlay / Onlays …
• Crowns -
• Short span bridges -
• Long span bridges -
• Removable partials -

AIGIS-PLUS is an inlay, onlay, crown and bridge alloy. This device is dependable 56% gold alloy with a high gold appearance. AIGIS-PLUS is excellent for inlays, three-quarter crowns, long and short-span bridges.

This 510(k) summary describes a dental casting alloy, AIGIS-PLUS, and aims to demonstrate its substantial equivalence to a legally marketed predicate device, ARGENCO 56. The study focuses on comparing the physical and mechanical properties and composition of the two alloys.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, the "acceptance criteria" are implied by the comparison to the predicate device, ARGENCO 56. The device is considered to meet acceptance criteria if its properties are "very similar" or "almost identical" to the predicate, with "minor differences" that "do not affect safety or effectiveness."

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

This document does not specify a separate "test set" in the context of typical algorithm validation. The "study" here is a comparison of material properties.

• Sample Size: Not explicitly stated. The table presents single values for each property, implying these are average or representative values obtained from testing unspecified sample sizes of both ARGENCO 56 and AIGIS-PLUS.
• Data Provenance: Not explicitly stated. It is implied that the data for AIGIS-PLUS was generated by the submitter (SB Lucius, Inc.) through their own testing, as they are providing this information for their new device. The data for ARGENCO 56 would presumably be from its existing regulatory submission or published material data. The country of origin for the data is not mentioned, but the submitter is based in Anaheim, CA, USA. The study is retrospective in the sense that the predicate device's data is pre-existing; the testing of AIGIS-PLUS to generate its performance data would be prospective.

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

Not applicable. This is not a study involving expert review for establishing ground truth, but rather a materials science comparison. The "ground truth" here is the measured physical and mechanical properties of the alloys.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as it's not and expert-based review. The comparison is based on objective measurements against a predicate device.

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. This is not a diagnostic device or an AI-enabled device. It is a dental casting alloy.

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

Not applicable. This is not an algorithm or AI-enabled device.

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

The "ground truth" for this study is based on standardized materials testing of the physical and mechanical properties of the dental alloys, as described by "Test methods applied: as in ANSI/ADA 5 and ISO 9693." These standards define the procedures for measuring properties like melting point, hardness, yield strength, elongation, and density.

8. The sample size for the training set

Not applicable. There is no training set for this type of material comparison study.

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

Not applicable, as there is no training set.

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