(84 days)
AIGIS-SUPER is intended for manufacturing
- Inlay / Onlays -
- Crowns -
- Short span bridges -
- Long span bridges -
- Removable partials -
AIGIS-SUPER is an inlay, onlay, crown and bridge alloy. This device is dependable 53% gold alloy with a high gold appearance. AIGIS-SUPER is excellent for inlays, three-quarter crowns, long and short-span bridges.
The provided document is a 510(k) summary for a dental casting alloy named AIGIS-SUPER. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, JENSEN'S JYE. The focus of the evaluation is on the material properties, not an AI/ML device.
Therefore, many of the questions regarding acceptance criteria for an AI/ML device, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document.
However, I can extract the acceptance criteria and performance data related to the physical and mechanical properties of the dental alloy.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for AIGIS-SUPER are implicitly defined by its substantial equivalence to the predicate device, JENSEN'S JYE. While explicit numerical ranges for acceptance aren't provided, the comparison of properties indicates that AIGIS-SUPER should have similar or acceptable ranges for these properties.
| Property | Predicate Device (JYE) | Test Device (AIGIS-SUPER) | Acceptance Criteria (Implicit from Predicate) | Meets Criteria? |
|---|---|---|---|---|
| Melting Point Range (°F) | 1,545 - 1,635 | 1,768 - 1,948 | Similar range to JYE | Yes (discussed) |
| Hardness (Vickers) | 170 | 150 | Similar to JYE (within reasonable tolerance) | Yes (discussed) |
| Yield Strength (MPa) | 345 | 300 | Similar to JYE (within reasonable tolerance) | Yes (discussed) |
| Elongation (%) | 23 | 21 | Similar to JYE (within reasonable tolerance) | Yes (discussed) |
| Density (g/cm³) | 12.8 | 13.8 | Similar to JYE (within reasonable tolerance) | Yes (discussed) |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a comparison of technological characteristics, specifically focusing on the composition and physical/mechanical properties. The test methods applied are stated as per ANSI/ADA 5 and ISO 9693.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test (e.g., how many samples were tested for hardness, melting point). The document presents summary values.
- Data Provenance: Not specified. It's a manufacturing specification/test rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not a diagnostic device involving expert interpretation of medical images or data. The "ground truth" here is the measured physical and mechanical properties of the material, assessed against established standards (ANSI/ADA 5 and ISO 9693) and comparison to the predicate device.
4. Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of expert opinions.
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 an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" in this context is the measured physical and mechanical properties of the dental alloy, determined through standardized test methods (ANSI/ADA 5 and ISO 9693). This is compared against the known properties of the legally marketed predicate device (JENSEN'S JYE).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set in the AI sense.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model.
§ 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.