(94 days)
Zone/Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements used for the cementation of temporary restorations.
Zone, Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements. They are self-cure materials that set by a reaction between Zinc Oxide present in the catalyst paste and Dimer Acid present in the base paste. The proposed temporary cements are to be placed in the mouth for up to 30 days. Zone comes in three options - the standard Zone cement, Zone A1 shade cement, and ZoneFree a translucent variant. The design of ZoneFree is based on Zone, but uses only small particle size Zinc Oxide to achieve both translucency and color-blending properties. Zone and Zone A1 are designed to set one minute slower than ZoneFree. The delivery systems include an automix syringe, 15 ml syringe, and a unit dose. Zone and Zone A1 are also available in a tube delivery.
The provided text describes a 510(k) premarket notification for dental cements (Zone, Zone A1, and ZoneFree) and focuses on demonstrating substantial equivalence to a predicate device (Temp-Bond NE 2). It does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/human reader performance study.
Instead, the document outlines the comparison of the new devices to the predicate based on non-clinical performance data and technological characteristics.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets the acceptance criteria using the information provided, as the nature of the information (dental cement characteristics) does not align with the type of study implied by the questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance).
The document explicitly states:
- "Clinical performance testing has not been performed for Zone/Zone A1 or ZoneFree." This directly indicates an absence of the type of human reader or AI performance study that your questions pertain to.
If the request were about the non-clinical acceptance criteria described in the document, here's how some of that information would be presented:
Non-Clinical Performance Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on ISO 3107 & FDA Guidance) | Reported Device Performance (Zone/Zone A1/ZoneFree) |
|---|---|
| Work time: Minimum of 90 seconds | Minimum of 90 seconds |
| Set time: Pass ISO 3107 requirements | Pass |
| Film thickness: Pass ISO 3107 requirements | Pass |
| Arsenic content: Pass ISO 3107 requirements | Pass |
| Compressive strength: Pass ISO 3107 requirements | Pass |
| Biocompatibility: Meets requirements (per ISO 10993) | Meets requirements |
| Shelf Life: 24 months | 24 months based on real time data |
However, this does not answer the specific questions about AI/human reader performance studies. The document demonstrates substantial equivalence through material properties and performance in laboratory settings, not through clinical or reader-based evaluations.
§ 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.