(49 days)
Nobel Biocare's Procera® AllCeram Fusing Material is a glass based powder which is mixed with distilled water. It is intended to be used to fuse together the sections of an aluminum oxide dental bridge.
The Nobel Biocare Procera® All Ceram Fusing Material is a glass powder, which is combined with distilled water to produce a mixture of "pasty" consistency. The Procera fusing material is used to fuse together the sections of a dental bridge. The dental bridge sections consists of densely sintered, high purity aluminum oxide copings and a pontic. Procera® AllCeram Porcelain is then applied to the surface of the dental bridge structure.
This document is a 510(k) summary for a dental fusing material, focusing on its substantial equivalence to predicate devices rather than clinical performance studies. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text.
Here is an analysis based on the given input:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, specific "acceptance criteria" and "reported device performance" in the context of a clinical study are not explicitly stated or detailed. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The closest interpretation of "acceptance criteria" here is the regulatory bar for substantial equivalence, which is whether the device has "essentially identical compositions" and "same intended use" as predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantially equivalent to predicate products in: | The Nobel Biocare Procera AllCeram Fusing Material is substantially equivalent to Vita In-Ceram (K#913644) and Gdc 3338, Dental Solder Alloy (K#920887). |
| - Composition | The Procera AllCeram Fusing Material has "essentially identical compositions" to In-Ceram. |
| - Intended Use | Both Procera AllCeram Fusing Material and Gdc 3338, Dental Solder Alloy are used to "fuse" sections/components of a dental bridge, thus having the "same intended use." |
| - Technological Characteristics | The technological characteristics between the Procera® AllCeram Fusing Material and the predicate products are "equivalent." |
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 provided in the document. The submission is a Pre-market Notification (510(k)) and primarily relies on a comparison to predicate devices, not on a clinical study with a "test set" in the traditional sense.
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 information is not provided. As no clinical study or "test set" is detailed, the establishment of ground truth by experts is not applicable to this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As no "test set" or clinical study with adjudicated results is described, an adjudication method is not applicable.
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
This information is not provided. The device is a "glass powder" for fusing dental bridge sections, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a physical material, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided. As there's no clinical trial or "test set" data presented, there's no ground truth data from such a study. The "ground truth" for this submission is implicitly the established properties and performance of the predicate devices for comparison.
8. The sample size for the training set
This information is not provided. The device is a physical material, not an AI or machine learning model. Therefore, a "training set" in the context of an algorithm is not applicable.
9. How the ground truth for the training set was established
This information is not provided. As there is no training set for an algorithm, the ground truth establishment for such a set is not applicable.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.