(96 days)
HILLA DIGITAL TRANSFERS are colored ceramic stains, supplied in a decal form, for firing onto dental ceramic prosthetic devices.
HILLA DIGITAL TRANSFERS are ceramic stain powders in a decal form, for application to dental ceramic prosthetic devices. The decals are applied and fired on ceramic dental restorations. After firing the decal, what remains is a silicate ceramic stains, which are substantially equivalent to the silicate ceramic stains disclosed in K000983.
The provided text describes a 510(k) summary for the HILLA DIGITAL TRANSFERS device. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, rather than proving device performance against specific clinical acceptance criteria through a study.
Therefore, the document does not contain information on the following:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set or data provenance
- Number of experts used to establish ground truth or their qualifications
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or the effect size of human readers with AI assistance
- Whether standalone (algorithm only) performance was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on establishing substantial equivalence. It states:
Device Description: "HILLA DIGITAL TRANSFERS are ceramic stain powders in a decal form, for application to dental ceramic prosthetic devices. The decals are applied and fired on ceramic dental restorations. After firing the decal, what remains is a silicate ceramic stains, which are substantially equivalent to the silicate ceramic stains disclosed in K000983."
Technological Characteristics vs. The Predicate Device: "HILLA DIGITAL TRANSFERS are essentially identical to the predicate device, the stain powders of the Ceramix Porcelain System, K000983." and "Both the HILLA DIGITAL TRANSFERS and Ceramix Porcelains System stains are applied to ceramic dental restorations to make the natural, esthetic, coloring effects at the incisal edges of such restorations. Both the HILLA DIGITAL TRANSFERS and Ceramix Porcelains System stains are fired to 850°C to burn off the organic components used to apply the HILLA DIGITAL TRANSFERS or the Ceramix Porcelains System stains."
Proof of Meeting Acceptance Criteria: The document directly states: "We believe that the performance data provided herein support the safety and effectiveness of use of HILLA DIGITAL TRANSFERS." However, it does not provide detailed performance data or a specific study design to quantitatively prove this. Instead, it relies on the argument of "substantial equivalence" to the predicate device (Ceramix Porcelain System, K000983). The basis for this equivalence is that the HILLA DIGITAL TRANSFERS contain "primarily the Ceramix Porcelain stains" and share the "same technological characteristics" and application process (firing to 850°C).
§ 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.