(41 days)
For the fabrication of a custom crown or bridge prosthesis by a dental laboratory. It is to be offered as an alternative to nickel-based crown and bridge alloys for nickel sensitive patients, as well as for international markets which prefer cobalt-based alloys.
P10 Special alloy is a cobalt based crown and bridge alloy containing chromium and molybdenum.
The provided document is a 510(k) summary for a dental alloy, not a medical device involving AI or machine learning. Therefore, the questions related to acceptance criteria, ground truth, expert adjudication, MRMC studies, and training/test sets are not applicable.
The document discusses the substantial equivalence of the "P10 Special" alloy to predicate devices based on:
- Compositional analysis: Showing a similar total Co/Cr/Mo sum percentage (89-94%) to predicate devices.
- Physical properties: Comparing yield strength and hardness to predicate devices.
- Performance testing by field laboratories: This is the closest aspect to "acceptance criteria" and "study."
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compositional Similarity: Total Co/Cr/Mo sum percentage similar to predicate devices. | P10 Special and predicate devices (Austenal "Advantage", Jeneric "RX Biocast", CMP "Vulcan") have a similar total Co/Cr/Mo sum percentage of 89-94%. |
| Physical Properties Similarity: Similar yield strength, hardness, and % elongation to predicate devices. | - P10 Special's yield strength is similar to "Advantage." |
- "P10 Special" has a higher yield strength but is not as hard as Vulcan.
- Vulcan exhibited somewhat higher % elongation than P10 Special (implied, as P10 Special is not as good in this specific aspect but still considered similar for overall equivalence). |
| Performance in Field Laboratories: Meet or exceed performance standards of traditional crown and bridge alloys. | Performance testing by field laboratories indicated that P10 Special met or exceeded performance standards of traditional crown and bridge alloys being utilized. (Note: specific quantitative acceptance criteria or detailed results of this performance testing are not provided in this summary) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The summary mentions "Performance testing by field laboratories," but neither the number of tests/samples nor the specific methodology is detailed.
- Data Provenance: Not specified, but "field laboratories" suggests real-world testing conditions. No country of origin is mentioned, and it's prospective testing as it's for a new product.
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 a material science and performance evaluation, not an expert-driven diagnostic assessment. The "field laboratories" would evaluate the material's properties and performance against established standards for dental alloys.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for clinical or diagnostic assessments involving human interpretation. The evaluation of material properties would follow standardized laboratory testing protocols.
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-driven diagnostic or assistive device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical alloy, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device would be established engineering and material science standards and specifications for dental crown and bridge alloys. This includes metallurgical testing for composition, yield strength, hardness, and elongation, as well as functional performance in simulated or actual fabrication conditions.
8. The sample size for the training set:
- Not applicable to this type of device.
9. How the ground truth for the training set was established:
- Not applicable to this type of device.
§ 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.