(101 days)
Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis) Final cementation of post and screws Final cementation of ceramic, composite or metal restorations on implant abutments Cementation of abutments made of Lava™ zirconium oxide ceramic
Unicem Aplicap/Maxicap cements are dual-curing, self-adhesive resin cements available in two single dose delivery systems in capsules (K020256). They are used for the permanent cementation of indirect restorations made of ceramic, composite, or metal, and for posts and screws. Bonding and conditioning of the prepared tooth structure are not necessary with Unicem Aplicap™ and Maxicap™M. Unicem Aplicap™ and Unicem Maxicap™ release fluoride ions, and are available in various shades. Unicem Aplicap™ and Unicem Maxicap™ contain bifunctional (meth)acrylate.
The provided text is a 510(k) summary for a dental cement (Unicem Aplicap/Maxicap). It focuses on establishing substantial equivalence to predicate devices and expanding indications for use, primarily through comparison of performance data and biocompatibility testing. The document does not contain information on clinical studies that would involve acceptance criteria, test sets, ground truth establishment, or human reader performance as typically seen with AI/CADe devices.
Therefore, many of the requested details cannot be extracted from this specific document.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a direct performance table as would be found for an AI/CADe device. It generally states that "the comparison for performance data and indications for use shows that Unicem Aplicap™ /Maxicap™ is substantially equivalent to its predicate devices."
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. The submission is for a dental cement, not an AI/CADe device that uses a "test set" of clinical data in this manner. The "performance data" mentioned likely refers to physical and chemical properties of the cement, not clinical image data.
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. Ground truth as typically understood for AI/CADe devices (e.g., expert consensus on medical images) is not relevant to this dental cement submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of clinical image interpretation. For dental cements, "ground truth" would likely refer to established physical and chemical properties and their compliance with relevant international standards, which are not detailed here beyond a general statement of "biocompatibility testing."
8. The sample size for the training set
Not applicable. This is not an AI/CADe device, and therefore does not have a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.