(80 days)
NEO 76 is intended for manufacturing
- Inlay / Onlays -
- Crowns -
- Short span bridges -
- Long span bridges -
- Removable partials -
NEO 76 is an inlay, onlay, crown and bridge alloy. This device is dependable 76% gold alloy with a high gold appearance. NEO 76 is excellent for inlays, threequarter crowns, long and short-span bridges.
The provided text describes the 510(k) summary for the dental casting alloy, NEO 76. This submission aims to prove substantial equivalence to a predicate device, ARGENCO 77, rather than establishing acceptance criteria and conducting a study to meet them in the traditional sense of a performance study measuring clinical outcomes.
Instead, the "acceptance criteria" here relate to the demonstration of similar technological characteristics to the predicate device, thereby inferring similar safety and effectiveness. The "study" refers to the comparison of composition, physical, and mechanical properties between the new device (NEO 76) and the predicate device (ARGENCO 77).
Here's an analysis based on the provided information:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a material, the "acceptance criteria" are implied to be the ranges and values of the predicate device's properties. The new device's performance is then compared to these.
| Characteristic | Acceptance Criteria (Predicate: ARGENCO 77) | Reported Device Performance (NEO 76) |
|---|---|---|
| Melting Point Range | 1,695 - 1,760 (°F) | 1,784 - 1,840 (°F) |
| Hardness (Vickers) | 105 | 148 |
| Yield Strength (MPa) | 214 | 270 |
| Elongation (%) | 36 | 48 |
| Density (g/cm3) | 15.9 | 16.1 |
| Composition | "almost identical" to ARGENCO 77 (implied) | "almost identical" to ARGENCO 77 (implied) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for testing or data provenance. The data presented are likely from laboratory tests conducted on the materials. It's a technical comparison of material properties, not a clinical study involving patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The "ground truth" for material properties is established by standardized testing methods (ANSI/ADA 5 and ISO 9693), not by expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically for clinical case review, not for material property testing.
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
There was no MRMC comparative effectiveness study. This device is a dental casting alloy, not an imaging device or AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is a material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the comparison is established by standardized material testing methods (ANSI/ADA 5 and ISO 9693) for physical and mechanical properties. For composition, elemental analysis would be used.
8. The sample size for the training set
This section is not applicable. There is no "training set" in the context of material property comparison for substantial equivalence.
9. How the ground truth for the training set was established
This section is not applicable. There is no "training set" or corresponding ground truth establishment in this type of submission.
Summary of the Study (Comparison for Substantial Equivalence):
The study conducted was a technical comparison of compositional and physical/mechanical properties between the new device (NEO 76) and a legally marketed predicate device (ARGENCO 77).
- Methods: The comparison was based on test methods applied as in ANSI/ADA 5 and ISO 9693. These standards define the procedures for measuring specific material properties like melting point, hardness, yield strength, elongation, and density. Compositional analysis would also have been performed.
- Findings: The submitter concluded that "The main elements and their concentration are almost identical" and presented a table comparing key physical and mechanical properties. While there are some numerical differences (e.g., NEO 76 has a slightly higher melting point range, hardness, yield strength, elongation, and density), the submitter's argument for substantial equivalence is based on these differences not affecting safety or effectiveness.
- Conclusion for Substantial Equivalence: The FDA's letter (K024141) confirms that the device was found substantially equivalent to the predicate device, indicating that the submitted comparison adequately demonstrated that the minor differences do not raise new questions of safety or effectiveness.
§ 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.