(90 days)
The above name products are intended for use as base metal casting alloys for casting removable partial denture frameworks.
The family of Base Metal Casting Alloys are cobalt chrome casting alloys substantially equivalent to the alloys currently used to produce partial denture frameworks.
The provided text describes material properties of dental alloys, not a medical device in the context of typical FDA 510(k) AI/ML device submissions (which usually involve diagnostic or therapeutic software/hardware). Therefore, many of the requested categories in your prompt are not applicable to this document.
However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets them based on the provided text.
Here's the information parsed according to your request, with "N/A" for categories that do not apply to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Requirement) | Reported Performance (Vitallium 2000 Alloy, Vitallium 2000 Plus Alloy, Cobalt Chrome Casting Alloy) |
|---|---|
| Composition: Cobalt + Chromium + Molybdenum ≥ 85% (ISO 6871, ANSI/ADA #14) | Vitallium 2000 Alloy: 98.3% |
| Vitallium 2000 Plus Alloy: 98.0% | |
| Cobalt Chrome Casting Alloy: 97.5% | |
| Mechanical Properties: 0.2% Yield Strength ≥ 500 MPa (ISO 6871, ANSI/ADA #14) | Vitallium 2000 Alloy: 609 MPa |
| Vitallium 2000 Plus Alloy: 690 MPa | |
| Cobalt Chrome Casting Alloy: 555 MPa | |
| Mechanical Properties: % Elongation ≥ 3% (ISO 6871, ANSI/ADA #14) | Vitallium 2000 Alloy: 8.9% |
| Vitallium 2000 Plus Alloy: 19.5% | |
| Cobalt Chrome Casting Alloy: 6.0% |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated, however, the data presented in the tables implies that samples of each alloy (Vitallium 2000 Alloy, Vitallium 2000 Plus Alloy, Cobalt Chrome Casting Alloy) were tested. The specific number of specimens or batches tested for each property is not provided.
- Data Provenance: The data appears to be from laboratory testing performed by the submitter (Austenal, Inc.). The country of origin of the data is implied to be the United States, given the Chicago address of the submitter. The data is prospective in the sense that it's a test of the specific new products against established standards, but it's not a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: N/A. Ground truth for material properties is established by adherence to international and national standards (ISO 6871, ANSI/ADA #14) and laboratory testing protocols, not by expert consensus in the diagnostic sense.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set
- Adjudication method: N/A. Material property testing adherence to a standard does not typically involve an adjudication method in the way a diagnostic study would. Results are quantitative measurements against defined thresholds.
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
- MRMC Study: No. This is not applicable to material property testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: N/A. This is not an algorithm or AI device. The "performance" is the inherent physical and chemical properties of the alloys.
7. The type of ground truth used
- Ground Truth Type: International and National Product Standards/Specifications.
- ISO Product Standard: ISO 6871, Base Metal Casting Alloys- Part I Cobalt Based Alloys
- ANSI/ADA Standard Specification ANSI/ADA # 14 Base Metal Casting Alloys
8. The sample size for the training set
- Training Set Sample Size: N/A. This material does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: N/A.
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.