(70 days)
BIO 60 is intended for use in the fabrication of implant superstructures and gold cylinders for dental implants.
Gold cylinder for using UCLA Abutment
This K041378 submission for the BIO 60 device, a gold cylinder for UCLA Abutment, relies on a comparison to a legally marketed predicate device, the Southern Implants Cylinder, using established industry standards rather than a clinical study with acceptance criteria in the traditional sense. Therefore, many of the requested fields are not applicable (N/A) as this is a material comparison and not an AI/software device.
Here's an analysis of the provided information based on the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Performance) | Reported Device Performance (BIO 60) |
|---|---|
| Composition (weight) | |
| Au (%): 60.00 | Au (%): 60.00 |
| Pt (%): 19.00 | Pt (%): 15.20 |
| Pd (%): 20.00 | Pd (%): 24.00 |
| In (%): 1.0 | In (%): 0.8 |
| Physical and Mechanical Properties | |
| Melting Point Range (°F): 1,475 | Melting Point Range (°F): 1,400-1,490 |
| Hardness (vickers): 265 | Hardness (vickers): 250 |
| Proof Strength (0.2%): 635 N/mm-2 | Proof Strength (0.2%): 645 N/mm-2 |
| CTE (x10-6/°C): 12.0 | CTE (x10-6/°C): 11.8 |
| Density (g/c x103m3): 18.5 | Density (g/c x103m3): 17.9 |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission is for a material comparison based on established test methods (ANSI/ADA 5 and ISO 9693) for dental alloys, not a clinical study on a "test set" in the context of image analysis or AI. The performance data presented are for the material itself.
- Data Provenance: The data provenance is derived from laboratory testing of the material's properties according to the specified standards. The country of origin of the data is not explicitly stated but would presumably be from the manufacturer's testing facilities or a contracted lab. This is retrospective data, as it reflects the properties of the manufactured material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. "Ground truth" in this context would refer to the accurate measurement of material properties, which are established through standardized laboratory tests, not by expert consensus or interpretation of images. The 'truth' is the measured physical and chemical properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically employed in studies where expert interpretation or consensus is required (e.g., medical imaging reads). This submission relies on objective, repeatable laboratory measurements of material properties.
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 submission is for a dental material (gold cylinder), not an AI or software device. Therefore, no MRMC study, human readers, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for a dental material, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the material comparison is the measured physical and chemical properties of the alloy, determined according to recognized industry standards (ANSI/ADA 5 and ISO 9693). This is objective, quantitative data from laboratory testing.
8. The sample size for the training set
- Not applicable. This submission is for a material comparison, not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI device, this question is not relevant.
§ 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.