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Self-curing glass ionomer based radiopaque filling cement, for dental use only. Recommended Indications:
(1) Restoration of primary teeth.
(2) Restorations of Class III, V and limited Class I cavities.
(3) Base linings under composite and amalgam.
(4) Core build-up.

Glass Ionomer Cement (Filling) has two types: Filling II. It is a device composed of various materials including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as a permanent or temporary tooth filling or as base linings. It's a powder liquid system. The basic operation principle of Glass Ionomer Cement (Filling) is acid-base reaction.

The provided document describes the acceptance criteria and the study (physical and chemical properties tests) for the "Glass Ionomer Cement (Filling)" device (K160345).

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for each physical and chemical properties test. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that it refers to ISO standards and a submission by a Chinese company, it's highly probable the testing was conducted in a laboratory in China following international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the study described is a series of laboratory-based physical and chemical properties tests against predefined ISO standards, not a clinical study involving human assessment or interpretation requiring expert ground truth establishment.

4. Adjudication method for the test set

This section is not applicable as the study described is a series of laboratory-based physical and chemical properties tests against predefined ISO standards. There is no mention of adjudication for these types of tests.

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

This section is not applicable. The document describes a traditional device clearance for a dental material (Glass Ionomer Cement), not an AI-powered diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable as the device is a physical dental material, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance criteria in this context is established by the ISO 9917-1:2007 standard for Dentistry — Water-based cements - Part 1: Powder/liquid acid-base cements. The reported performance is a direct measurement against these internationally recognized physical and chemical property specifications.

8. The sample size for the training set

This section is not applicable as the device is a physical dental material and not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

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• As a structural reinforcement for fabricating and/or repairing Class III and Class V restorations
• Restoration of root surface caries
• Restorations of cervical erosions
• Small Class I restorations
• Primary teeth restoration
• Core build up
• Liner

Virto Fil LC is a dental cement that is composed of varoius 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. Vitro Fil LC is a resin modified glass ionomer base cement used as a temporary tooth filling. Vitro Fil LC offers a strong bonding of the ionomer to the tooth. The glass ionomer offers high chemical adhesion, fluoride release and biocompatibility. Vitro Fil LC is for permanent cementation.

This document, K123824, is a 510(k) premarket notification for a dental cement called "Vitro Fil LC." It does not contain information about a study with acceptance criteria and reported device performance in the context of evaluation using a test set, ground truth, or expert review, as would be expected for an AI/ML powered device.

Rather, this document is a regulatory approval for a medical device (dental cement) based on its substantial equivalence to previously marketed predicate devices. The safety and effectiveness are established by comparing its intended use, materials, form factor, performance, and safety characteristics to those of the predicate devices.

Therefore, I cannot provide the requested information as it is not present in the provided text. The sections requested (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are typically associated with the evaluation of AI/ML software or diagnostic devices, not with traditional material-based medical devices like dental cement undergoing a 510(k) substantial equivalence review.

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