(84 days)
AIGIS-FINE is intended for manufacturing
- Inlay / Onlays -
- Crowns -
- Short span bridges -
- Long span bridges -
- Removable partials -
AIGIS-FINE is an inlay, onlay, crown and bridge alloy. This device is dependable 7 1% gold alloy with a high gold appearance. AIGIS-FINE is excellent for inlays, three-quarter crowns, long and short-span bridges.
This 510(k) summary describes a dental casting alloy, AIGIS-FINE, and its substantial equivalence to a predicate device, AUROFLUID M. The substantial equivalence is based on a comparison of composition and physical/mechanical properties.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the properties of the predicate device, AUROFLUID M. The newer device, AIGIS-FINE, is considered acceptable if its properties are substantially equivalent and do not negatively impact safety or effectiveness.
| Property | Acceptance Criteria (AUROFLUID M) | Reported Device Performance (AIGIS-FINE) |
|---|---|---|
| Composition (Weight %) | Very similar to AUROFLUID M | "Main elements and their concentration are almost identical" |
| Gold (Au) | Not explicitly stated, implied to be high | 71% gold alloy (implied to be similar to AUROFLUID M) |
| Melting Point Range (°F) | 1,687-1,777 | 1,730-1,832 |
| Hardness (Vickers) | 155 | 145 |
| Yield Strength (MPa) | 340 | 250 |
| Elongation (%) | 27 | 26 |
| Density (g/cm3) | 15.4 | 15.19 |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The comparison is made based on material properties, which are typically derived from standardized testing of material samples. The text does not provide details on the number of samples tested for each property.
- Data Provenance: Not explicitly stated. The data is presented as a comparison between the applicant's device (AIGIS-FINE) and a legally marketed predicate (AUROFLUID M). It's reasonable to assume the AIGIS-FINE data was generated by the applicant (SB LUCIUS, INC.), likely from laboratory testing. The provenance of the AUROFLUID M data is not mentioned but would have been established during its own regulatory approval. The study is retrospective in the sense that it relies on existing data for the predicate device and newly generated data for the proposed device for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of study does not involve experts establishing ground truth for a test set in the way a diagnostic imaging AI algorithm would. Instead, the "ground truth" for material properties is established through standardized laboratory testing (as in ANSI/ADA 5 and ISO 9693). The results of these tests (melting point, hardness, yield strength, etc.) are objective measurements, not subjective expert opinions.
4. Adjudication method for the test set
Not applicable. There is no adjudication method described as this is a comparison of material properties, not a review of expert 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 is a comparison of material properties for a dental casting alloy, not a diagnostic imaging device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material science comparison, not an algorithmic performance study.
7. The type of ground truth used
The ground truth used is based on standardized physical and mechanical property measurements of the dental alloy. These are objective laboratory measurements, not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This is not a machine learning study, so there is no concept of a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for it.
§ 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.