(142 days)
- Lucitone Digital Print™ 3D Denture Base is a light-cured resin indicated for the fabrication of denture bases including full and partial dentures and implant overdentures, and implant overdentures and other dental appliances.
- Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is used as a try-in material for evaluation prior to fabrication of the final restoration or a temporary denture.
- Lucitone Digital IPN™ 3D Premium Tooth is a light-cured resin intended for printing denture teeth.
- Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is intended for printing full arch and tooth segments.
- Lucitone Digital Fuse™ Step 1 - 3D Tooth Conditioning Agent is indicated for use in enhancing the bond of denture teeth to denture base and denture base to denture base.
- Lucitone Digital Fuse™ Step 2 - 3D Denture Bonding Resin is utilized as an aid in bonding denture teeth to denture base as well as repair using traditional techniques.
- Lucitone Digital Fuse™ Step 3 – Total 3D Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.
Lucitone Digital Print Denture System is a methacrylate-based, light-cured denture base resin which is intended for use by dental clinician to fabricate dental prostheses using an additive printer and CAD/CAM technologies or as a try-in denture. The workflow utilizes several support components that aid in conditioning, bonding or sealing to provide a smooth finish to the device. The Lucitone Digital Print Denture System conforms to the physical and mechanical property requirements for ISO 20795-1:2013.
This looks like a 510(k) summary for a medical device. Based on the provided text, there is no clinical performance data included to describe acceptance criteria or prove the device meets acceptance criteria through a study involving human subjects or AI performance metrics.
The document explicitly states:
"8. Clinical Performance Data
Not applicable, no data from human clinical studies has been included to support the substantial equivalence of the proposed Lucitone Digital Print Denture System."
Therefore, I cannot provide the requested information regarding:
- 1. A table of acceptance criteria and the reported device performance
- 2. Sample size used for the test set and the data provenance
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- 4. Adjudication method
- 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
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- 7. The type of ground truth used
- 8. The sample size for the training set
- 9. How the ground truth for the training set was established
The provided document focuses on non-clinical performance data and adherence to ISO standards and FDA guidance documents for medical devices (specifically denture base resins and additive manufacturing), demonstrating substantial equivalence to a predicate device. This typically involves bench testing, material properties, and biocompatibility, not clinical studies or AI performance evaluations as described in your prompt.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.