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· Permanent cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
· Permanent cementation for all types of root canal posts.
· Core build-ups.

TopCEM Dual Cure Resin Cement is a versatile and ultimate dental dual cure (chemical and/or light cure) luting cement containing paste-paste of Base and Catalyst. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste. It is also a core build up material in syringes. The principal organic components are mixtures of dental methacrylate resins (TEGDMA, EBPADMA and UDMA). The inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 3 microns. TopCEM Dual Cure Resin Cement is delivered in either two separated single syringes for Hand-mix or double-barrel syringes for Automix and comes in seven shades: TR (Translucent), A0 (Light+), A1 (Light), A2 (Medium), A3 (Dark), White Opaque) and Opaque (Universal Opaque). TopCEM Dual Cure Resin Cement is radiopaque, allowing for easy identification on radiographs. It belongs to Type 2 Class 3 dual cure materials in accordance with ISO 4049. The curing mechanism of the predicate devices and subject device is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator and chemical polymerization initiator systems.

The provided text describes the 510(k) premarket notification for a dental product called "TopCEM Dual Cure Resin Cement" and its substantial equivalence to predicate devices. This document refers to the safety and efficacy of a material (dental cement), not a device in the context of an AI/ML-based diagnostic or imaging device.

Therefore, the requested information regarding acceptance criteria and studies that prove a device meets criteria (such as sample sizes, expert-established ground truth, MRMC studies, standalone performance, training set details, etc.) is not applicable to this document.

The document focuses on the physical, chemical, and biocompatibility properties of the dental cement, demonstrating its similarity to existing, legally marketed predicate devices through bench testing and adherence to international standards (ISO 4049, ISO 29022) and FDA guidance for dental composite resin devices.

Key points from the document relevant to its acceptance:

• Acceptance Criteria for the Dental Cement: The acceptance criteria for this dental cement are based on adherence to specific physical and chemical property standards outlined in ISO 4049 and ISO 29022, as well as FDA guidance for dental composite resin devices.
  • ISO 4049: This standard specifies requirements for resin-based dental restorative materials.
  • ISO 29022: This standard specifies test methods for the evaluation of bond strength of dental adhesive systems.
  • FDA Guidance: "Guidance for Industry and FDA Staff Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions Document issued on: October 26, 2005."
• Demonstration of Performance: The device's performance was demonstrated through bench testing against these established standards and internal company standards.
• Substantial Equivalence: The primary method of acceptance is demonstrating "substantial equivalence" to legally marketed predicate devices, meaning it is as safe and effective as a legally marketed device. This is primarily established by comparing:
  • Indications for Use
  • Technological Characteristics (monomer matrix, fillers, physical form, curing method, delivery form, radiographic appearance)
  • Physical/Chemical Properties (conformance to ISO standards)
  • Biocompatibility (conformance to ISO 10993 standards)

Table of Acceptance Criteria and Reported Device Performance (as presented in the document for TopCEM Dual Cure Resin Cement):

Regarding the specific questions about device performance as if it were an AI/ML device:

1. AI/ML Acceptance Criteria/Performance Table: Not applicable. The device is a dental cement, evaluated by material properties, not AI/ML metrics like sensitivity, specificity, or AUC.
2. Sample sizes for test set and data provenance: Not applicable. No test set of medical images or patient data was used. Performance was based on bench tests of material samples.
3. Number of experts and qualifications for ground truth: Not applicable. Ground truth was established by physical, chemical, and biocompatibility testing according to ISO standards, not expert clinical interpretation.
4. Adjudication method: Not applicable. Material properties are objectively measured, not subject to adjudication.
5. MRMC comparative effectiveness study: Not applicable. No human readers or AI assistance in a diagnostic context.
6. Standalone (algorithm only) performance: Not applicable. The device is a material, not an algorithm.
7. Type of ground truth used: Bench test results from standardized physical, chemical, and biocompatibility tests.
8. Sample size for training set: Not applicable. There is no software or AI model to train.
9. How ground truth for training set was established: Not applicable.

In conclusion, the provided document clearly details the regulatory submission and acceptance of a dental material based on its chemical, physical, and biocompatibility properties, demonstrating substantial equivalence to predicate devices through standardized bench testing. It does not relate to the performance of an AI/ML-based medical device.

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