(41 days)
OPC LowWear™ Porcelain (enamel and incisal for mixing) is to be used in conjunction with Optimal Pressable Ceramic (OPC) pellets for all-ceramic fixed prosthodontics, inckluding full crowns, veneers and inlays/onlays. These translucent porcelains are applied in thin layers over the OPC pellet pressed ceramic cores. The average crystal size of the leucite within the LowWear Porcelain glassy matrix is 2-3 µm, with a crystal size range between 1-4 µm. The smaller leucite crystals vs. conventional porcelains and other all-ceramic porcelains (average 8 um, range 1-40 um) results in less abrasion against opposing dentition, as supported by independent testing from Dr. Shiro Suzuki, University of Alabama at Birmingham.
OPC LowWear™ Porcelain (enamel and incisal for mixing) is to be used in conjunction with Optimal Pressable Ceramic (OPC) pellets for all-ceramic fixed prosthodontics, inckluding full crowns, veneers and inlays/onlays. These translucent porcelains are applied in thin layers over the OPC pellet pressed ceramic cores. The average crystal size of the leucite within the LowWear Porcelain glassy matrix is 2-3 µm, with a crystal size range between 1-4 µm. The smaller leucite crystals vs. conventional porcelains and other all-ceramic porcelains (average 8 um, range 1-40 um) results in less abrasion against opposing dentition, as supported by independent testing from Dr. Shiro Suzuki, University of Alabama at Birmingham.
This document is a 510(k) premarket notification letter for a dental device, specifically "OPC LowWear™ Porcelain." It primarily focuses on the regulatory approval and indications for use, rather than a detailed study report with specific acceptance criteria and performance data.
Therefore, much of the requested information regarding detailed acceptance criteria, study methodologies, statistical results, ground truth establishment, and training set information is not present in the provided text.
However, based on the available information, here's what can be extracted:
Acceptance Criteria and Study Details (Based on provided text):
The document does not explicitly present a table of acceptance criteria with corresponding device performance values. However, it mentions the basis for the device's claim regarding low wear.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reduction in Abrasion against Opposing Dentition (This is the primary performance claim highlighted for "LowWear" porcelain, implicitly requiring a lower abrasive effect compared to predicate devices or conventional porcelains). | "The smaller leucite crystals vs. conventional porcelains and other all-ceramic porcelains (average 8 um, range 1-40 um) results in less abrasion against opposing dentition, as supported by independent testing from Dr. Shiro Suzuki, University of Alabama at Birmingham." |
(The document states the support, but does not provide the quantitative results or acceptance threshold from the "independent testing"). |
| Material Characteristics (Related to the mechanism for low wear) | Average crystal size of leucite: 2-3 µm
Crystal size range of leucite: 1-4 µm
(This is stated as a characteristic, which presumably meets an internal specification for the "LowWear" claim, but no specific acceptance range for these values is given in relation to a performance metric). |
Additional Information based on the text:
- Sample size used for the test set and the data provenance: Not specified in the provided text. The document only references "independent testing from Dr. Shiro Suzuki, University of Alabama at Birmingham." without detailing the test set size or whether it was retrospective or prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. The testing was done by "Dr. Shiro Suzuki, University of Alabama at Birmingham," implying one expert or a team led by Dr. Suzuki, but the number and qualifications are not detailed.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in the provided text. It refers to "independent testing," which would typically follow a scientific methodology, but the adjudication process for results is not described.
- 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 device is a dental material (porcelain), not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a dental material, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" or evidence for the low-wear claim likely comes from experimental test data (e.g., in-vitro abrasion tests mimicking dental function or potentially in-vivo studies, although the document doesn't specify). This data was generated by "independent testing."
- The sample size for the training set: Not applicable. This is a manufactured dental material, not a machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of missing information:
The provided 510(k) clearance letter is a regulatory document affirming substantial equivalence to a predicate device. It confirms the device's indications for use and acknowledges the supporting "independent testing" for the low-wear claim but does not provide the detailed scientific study report that would contain the quantitative acceptance criteria, methodology, specific performance data, sample sizes, and ground truth establishment details. To get that information, one would typically need access to the actual "independent testing" report referenced.
§ 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.