(103 days)
Luxatemp Ultra/Star is a self-curing or dual-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers.
Luxatemp Ultra/Star is intended for the fabrication of:
- temporary crowns
- bridges
- inlays
- onlays
- long-term temporaries
- temporary veneers .
Luxatemp Ultra/Star is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture or partial denture.
Luxatemp Ultra/Star is a self-curing or dual-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers. Luxatemp Ultra/Star will be supplied in 2 formulations; one is self-curing and the other is dual-cure. The 2 formulations vary slightly in composition to achieve the desired curing properties. The lonnations vary circure and self-cure formulations will be supplied in both Smartmix syringes and Automix cartridges. "Luxatemp Ultra" and "Luxatemp Star" are different trade names for the same material
The provided text describes a 510(k) premarket notification for a dental material, Luxatemp Ultra/Star, intended for temporary dental restorations. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with human readers or AI algorithms as would be expected for a diagnostic AI device.
Therefore, many of the requested points are not applicable to this specific submission. However, I will extract the relevant information and explicitly state when a point is not applicable.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
The document states that Luxatemp Ultra/Star aims to be "equivalent to or better than the predicate devices." While specific numerical acceptance criteria (e.g., minimum compressive strength) are not provided in detail within the summary, the document indicates compliance with ISO and a comparison to the predicate.
| Acceptance Criteria Category | Predicate Device Standard / Regulation | Reported Device Performance (Luxatemp Ultra/Star) |
|---|---|---|
| Biocompatibility | ISO 7405:2008 Dentistry - Evaluation of biocompatibility | Complies with requirements of ISO 7405:2008 |
| Material Properties | ISO 4049:2000 Dentistry - Polymer-based filling, restorative, and luting materials (where applicable) | Equivalent to or better than the predicate device in terms of compressive strength, flexural strength, tensile strength, hardness, water sorption, working time, and curing time. |
| Substantial Equivalence | Comparison to legally marketed predicate (DMG USA Luxatemp cleared in K013674) | "Substantially equivalent" to predicate based on indications for use, technological characteristics, and material properties. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. This submission is for a dental material and does not involve a "test set" of patient data or images in the context of an AI/diagnostic device. The testing involved material property measurements. The document does not specify the sample size for these material tests or their geographic origin, but typical premarket submissions for materials involve laboratory testing.
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)
Not Applicable. This submission is for a dental material. The "ground truth" for material properties is established by standardized laboratory testing methods, not by expert consensus or interpretations of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. This submission is for a dental material. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving interpretation (e.g., by human readers), which is not relevant here.
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 submission is for a dental material and does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This submission is for a dental material and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established physical and chemical properties of dental materials as determined by standardized laboratory tests. These tests are designed to measure properties like compressive strength, flexural strength, tensile strength, hardness, water sorption, working time, and curing time according to recognized international standards (ISO 4049:2000 and ISO 7405:2008). The predicate device's established performance served as the benchmark for demonstrating equivalence or superiority.
8. The sample size for the training set
Not Applicable. This submission is for a dental material and does not involve machine learning or a "training set" of data.
9. How the ground truth for the training set was established
Not Applicable. This submission is for a dental material and does not involve machine learning or a "training set." The performance of the material is established through direct, standardized laboratory testing.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.