AIGIS-INLAY by SB LUCIUS, INC. | FDA 510(k) Summary

This 510(k) summary describes a dental casting alloy, AIGIS-INLAY, and asserts its substantial equivalence to a legally marketed predicate device, DEGULOR A. The acceptance criteria and the study proving it meets these criteria are based on direct comparison of physical and mechanical properties and composition.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by comparing the AIGIS-INLAY to the predicate device, DEGULOR A, based on specific physical and mechanical properties, and composition. The underlying standard referenced is ANSI/ADA 5 and ISO 9693. Given this is a material comparison for substantial equivalence, the "acceptance criteria" are effectively that the new device's properties are "very similar" or fall within an acceptable range compared to the predicate.

Property	Acceptance Criteria (based on DEGULOR A)	Reported Device Performance (AIGIS-INLAY)
Composition	"almost identical" to DEGULOR A	Main elements and their concentration are "almost identical"
Melting Point Range (°F)	1,912-2,002	1,922-2,002
Hardness (Vickers)	55	60
Yield Strength (MPa)	80	85
Elongation (%)	45	45
Density (g/cm³)	17.2	17.2

Study to Prove Acceptance Criteria:

The study used to prove the device meets the acceptance criteria is a direct comparison of composition and physical/mechanical properties between the AIGIS-INLAY and the predicate device, DEGULOR A. The methods applied are "as in ANSI/ADA 5 and ISO 9693," which are international standards for dental casting alloys. The conclusion reached is that the AIGIS-INLAY is "substantially equivalent" to DEGULOR A, and "minor differences between them do not affect safety or effectiveness."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document presents single-point values for each property for both the predicate and the new device. It does not provide information on the number of samples tested to arrive at these values.
Data Provenance: Not specified. It can be assumed that the data for AIGIS-INLAY was generated by the manufacturer (SB LUCIUS, INC.)
Retrospective or Prospective: Not applicable as this is a material properties comparison, not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for this device (a dental casting alloy) is established by comparing its physical and mechanical properties against recognized dental material standards (ANSI/ADA 5 and ISO 9693) and a legally marketed predicate device, not by expert consensus on clinical cases.

4. Adjudication method for the test set:

Not applicable. This is a technical comparison of material properties, not a study requiring adjudication of clinical findings or interpretations.

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 document pertains to a dental casting alloy, not an AI-powered diagnostic device.

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

Not applicable. This document pertains to a dental casting alloy, not an algorithm.

7. The type of ground truth used:

The ground truth used is primarily physical and mechanical property measurements as defined by the standards ANSI/ADA 5 and ISO 9693, and chemical composition analysis. The properties of the predicate device (DEGULOR A) serve as the benchmark for substantial equivalence.

8. The sample size for the training set:

Not applicable. This is a device substantial equivalence submission, not a machine learning model.

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

Not applicable. This is a device substantial equivalence submission, not a machine learning model.

Summary

Regulation Number and Section

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.