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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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Halley resin is a light-cured resin indication of dentures bases in dental laboratories, including full and partial dentures as well as implant overdentures, and other dental appliances. 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.

The proposed Halley resin is a methacrylate-based, light-cured resin available in multiple shades and is intended as an alternative to traditional heat cured and autopolymerization denture base resins. The Halley resin is intended to be utilized primarily for the fabrication of dental prostheses using an additive printer and CAD/CAM techniques. The proposed Halley resin can also be used for traditional repairs and as an aid in bonding denture base to denture teeth.

In addition, Halley resin may also be utilized as an aid in bonding the printed denture to teeth as well as for repair.

The document describes the acceptance criteria and study proving the device meets them for the "Halley resin."

1. Table of Acceptance Criteria and Reported Device Performance:

*Note: Data for the predicate device, NextDent™ Denture / E-Denture (K162572), is derived from its 510(k) Summary, Appendix A.
**Note: Data for the reference device, Pour Acrylic (K161330), is available to Dentsply Sirona.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a distinct "test set" sample size in terms of number of cases or data provenance in the way it might for a diagnostic AI. The testing described is for the physical and biocompatibility properties of the material itself.

For the physical properties, the testing was conducted in accordance with ISO 20795-1:2013 (Dentistry – Base polymers - Part 1: Denture base polymers). This standard would define the sample sizes and methodology for testing material properties. The data provenance is not explicitly stated as country of origin, but it is implied to be laboratory testing following international standards. The nature of the study is a laboratory-based, non-clinical performance evaluation, not a retrospective or prospective study on patient data.

For biocompatibility, the testing was conducted in accordance with several ISO 10993 series standards (ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-6, ISO 10993-3). These are also laboratory-based, non-clinical tests on the material, not human or animal studies with a "test set" in the traditional sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is not applicable to the type of device and testing described. The "ground truth" for material properties is established by adherence to recognized international standards (ISO 20795-1:2013) that define acceptable performance limits. The "ground truth" for biocompatibility is conformance to ISO 10993 series of standards. These standards do not involve expert consensus in the way a clinical image interpretation might.

4. Adjudication Method for the Test Set:

This is not applicable. The testing involves objective measurements of material properties and biological responses according to established standard protocols, rather than subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. without AI Assistance:

No, an MRMC comparative effectiveness study was not done. The "Halley resin" is a dental material, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no AI assistance aspect or human reader performance to evaluate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance study was not done, as the device is a dental material, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for performance evaluation is based on established international standards:

• For physical properties: ISO 20795-1:2013 (Dentistry – Base polymers - Part 1: Denture base polymers)
• For biocompatibility: ISO 10993 series of standards (ISO 10993-5, -10, -11, -6, -3)

These standards define the test methods and the acceptable specification limits for the relevant material properties.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable to this device. The Halley resin is a physical material whose properties are evaluated through laboratory testing against established standards, not through training an algorithm on a dataset.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable, as there is no training set for this device.

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