(159 days)
Dental Casting alloy used for fabrication of metallo-ceramic restorations in conjunction with dental ceramics of thermal expansion co-efficient not less than 16.3 x 10 -9K. (25 - 600°C)
High gold casting alloy
The provided text describes the 510(k) summary for AURENORM 68, a dental casting alloy, and its comparison to a legally marketed predicate device, Jelenko Allround 4. The focus is on demonstrating substantial equivalence based on technological characteristics rather than clinical performance from a study. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" as it pertains to AI/medical imaging performance metrics cannot be fully answered in the typical sense.
However, I can extract and structure the information provided in a way that aligns with the spirit of your request, interpreting "acceptance criteria" as the comparison points for demonstrating substantial equivalence and "reported device performance" as the properties of AURENORM 68.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices applying for 510(k) clearance, the "acceptance criteria" for demonstrating substantial equivalence often involve showing that the new device has similar technological characteristics (composition, physical, and mechanical properties) and intended use as a predicate device. The "study" in this context is the comparison of these characteristics.
| Acceptance Criteria (Predicate Device Values) | Reported Device Performance (AURENORM 68 Values) | Property |
|---|---|---|
| 69.0 wt% | 68.9 wt% | Gold (Au) Composition |
| 13.9 wt% | 12.1 wt% | Silver (Ag) Composition |
| 9.0 wt% | 9.9 wt% | Platinum (Pt) Composition |
| 4.5 wt% | 6.9 wt% | Copper (Cu) Composition |
| 2.0 wt% | 0.9 wt% | Zinc (Zn) Composition |
| 1.6 wt% | 0.7 wt% | Indium (In) Composition |
| 0.0 wt% | 0.6 wt% | Ruthenium (Ru) Composition |
| 78% - calculated from 68.9+12.1+9.9 = 90.9%) | Noble Metal Content | |
| Similar to legally marketed device | Claimed "basically similar composition and physical, mechanical properties" | Overall Similarity |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to the provided document. The submission is a 510(k) summary for a material (dental alloy) and does not involve a clinical study with a test set of data like an AI/imaging device would. The "test methods applied" refer to industry standards for material testing (ANSI/ADA 5, ISO 1562, and 9693), not a clinical trial or performance evaluation using patient data.
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)
Not applicable. Ground truth as typically understood in AI/imaging studies (e.g., expert consensus on medical images) is not relevant for this type of device submission. The "ground truth" here is the measured physical and chemical properties of the alloy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication for a test set is described.
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 a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material submission, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context would be the empirical measurements of the chemical composition and physical/mechanical properties of the alloy (Aurenorm 68 and Allround 4) adhering to the specified industry standards (ANSI/ADA 5, ISO 1562, and 9693).
8. The sample size for the training set
Not applicable. There is no training set in the context of this device submission.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in the document.
§ 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.