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

AIGIS-SOFT is an inlay, onlay, crown and bridge alloy. This device is dependable 83% gold alloy with a high gold appearance. AIGIS-SOFT is excellent for inlays, three-quarter crowns, long and short-span bridges.

AI/ML Overview

Here's an analysis of the provided text regarding the AIGIS-SOFT device, focusing on acceptance criteria and the supporting study:

Key Takeaway: This 510(k) summary is for a dental casting alloy, not a software or AI-driven medical device. Therefore, the questions regarding AI performance, reader studies, ground truth establishment for algorithms, and training set sizes are not applicable to this submission. The "study" described is a comparison of material properties to a predicate device.

Acceptance Criteria and Device Performance

The acceptance criteria for AIGIS-SOFT are not explicitly stated as numerical targets in the same way one might find for a diagnostic device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device (ARGENCO 83) based on composition and physical/mechanical properties. The performance is assessed by comparing these properties.

Table of Acceptance Criteria and Reported Device Performance

Criterion (Implicit Acceptance)	Predicate Device (ARGENCO 83) Performance	AIGIS-SOFT Performance	Meets Acceptance Criteria?
Composition	Main elements & concentrations not explicitly detailed, but implied to be "very similar" to AIGIS-SOFT	Main elements & concentrations similar to ARGENCO 83 (implied high gold content)	Yes (based on "almost identical" main elements and concentration)
Melting Point Range	1,730-1,760 °F	1,922-2,002 °F	Yes (difference not deemed to affect safety/effectiveness)
Hardness (Vickers)	80	60	Yes (difference not deemed to affect safety/effectiveness)
Yield Strength (MPa)	103	85	Yes (difference not deemed to affect safety/effectiveness)
Elongation (%)	35	45	Yes (difference not deemed to affect safety/effectiveness)
Density (g/cm³)	16.6	17.2	Yes (difference not deemed to affect safety/effectiveness)
Biological Compatibility	Assumed safe	Assumed safe (due to similar composition)	Yes (based on assumption of similar biocompatibility)
Intended Use	Inlay, onlay, crown and bridge alloy	Inlay, onlay, crown and bridge, short/long span bridges, removable partials	Yes (similar intended uses)

Summary of the Study:

The study proving the device meets the acceptance criteria is a comparison study against a predicate device, ARGENCO 83 (K893384). The core of the study involved:

Chemical Composition Analysis: Comparing the elemental composition (though specific percentages are not fully tabulated for both in the provided text). The submission states, "The main elements and their concentration are almost identical."
Physical and Mechanical Properties Testing: Measuring key properties such as melting point, hardness, yield strength, elongation, and density for both AIGIS-SOFT and the predicate device. These are presented in a direct comparison table.

The conclusion drawn from this comparative study is that "AIGIS-SOFT is substantially equivalent to ARGENCO 83 and the minor differences between them do not affect safety or effectiveness."

Specific Information Requested:

Given the nature of the device (a dental alloy), most of the requested points related to AI/software performance are not applicable.

Table of Acceptance Criteria and Reported Device Performance: (See table above). The acceptance criterion is "substantial equivalence" to the predicate, with reported performance being the direct comparison of material properties.
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in terms of number of units of alloy tested, but implies standard material testing methods (e.g., tensile tests, hardness measurements) would involve multiple samples. No "test set" in the context of an algorithm.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It's standard materials testing data, likely generated in a lab setting.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- N/A. This is a material properties comparison; there's no "ground truth" established by human experts in the context of diagnostic interpretation. Physical measurements (e.g., melting point, hardness) are empirically determined.
Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- N/A. No expert adjudication is applicable for material property measurements.
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:
- N/A. AIGIS-SOFT is a physical dental alloy, not an AI or imaging device, so no MRMC study was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Empirical Measurement Data: The "ground truth" for the properties comes from direct physical and chemical measurements (e.g., melting point via calorimetry, hardness via Vickers indenter, elemental composition via spectroscopic methods). The "truth" for biocompatibility is inferred from chemical similarity.
The sample size for the training set:
- N/A. There is no "training set" as this is not a machine learning algorithm.
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for an algorithm.

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.