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• 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.

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Halley resin is a light-cured resin indicated for the fabrication of dental laboratories, including full and partial dentures as well as implant overdentures. Halley resin can be used as a try-in material for evaluation prior to fabrication of the final restoration of these prostheses require a computer-aided design and manufacturing (CAD/CAM) system using an additive printer.

Halley resin can be utilized as an aid in bonding denture teeth as well as repair using traditional techniques.

Halley Denture-Tooth Bonding Agent is indicated for use in enhancing the bond of denture base.

Halley Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.

The proposed device, Halley resin system introduces two additional components (Halley Denture-Tooth Bonding Agent and Halley Sealer) to the Halley resin (K190043) workflow. The proposed Halley resin system consists of light-cured resins that support the modification of the Halley resin (K190043) workflow to include bonding and sealing steps using conventional techniques. The two additional components of the Halley resin system have previously been cleared under Eclipse® Bonding Agent. K051707 and TEMPEX Esthetic Provisional System. K061264. For comparison purposes, the reference device VLC Sealer (part of the TEMPFX Esthetic Provisional System, K061264) is being included. These devices are being included as reference devices (Eclipse® Bonding Agent, K051707 and TEMPFX Esthetic Provisional System, K061264) to support chemical composition and characteristics to support the Halley resin (K190043) workflow.

The provided text describes a 510(k) premarket notification for a dental device, the Halley Resin System. This submission establishes substantial equivalence to a predicate device (Halley resin K190043) and reference devices (Eclipse® Bonding Agent K051707 and TEMPFX Esthetic Provisional System K061264).

Crucially, this document is for a dental resin system, not an AI/ML-driven medical device for diagnosis or prognosis. Therefore, the requested information about acceptance criteria, study types (MRMC, standalone), ground truth establishment, sample sizes for training/test sets, expert adjudication, and effect sizes for human reader improvement with AI assistance do not apply to this submission.

The document discusses non-clinical performance data, specifically physical properties and biocompatibility testing of the resin system components, to demonstrate that the proposed device performs as intended and is safe. It explicitly states that "No data from human clinical studies has been included to support the substantial equivalence of the proposed device, Halley resin system."

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document describes a traditional medical device submission based on material properties and established workflows using existing, cleared components.

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