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Final cementation of

• Metal inlays, onlays, crowns and bridges
• Resin inlays, onlays, crowns and bridges
• Ceramic inlays
• Zirconia crowns and bridges
• Metal, ceramic and fiber posts

EsCem RMGI is a radiopaque resin modified glass ionomer luting cement corresponding to ISO 9917-2, Class 3. This product facilitates the removal of excess cement through the tack-cure option, allowing for quick treatment. The contents consisting of base and catalyst are provided in a dual syringe and are used to cement indirect restoration by mixing the two types of paste.

This is a 510(k) premarket notification for a dental cement, EsCem RMGI. The provided document does not contain any information about an AI/ML powered device or a study involving human readers or AI assistance. It focuses solely on the substantial equivalence of the dental cement to a predicate device based on its physical and chemical properties and biocompatibility.

Therefore, I cannot provide an answer that includes:

• A table of acceptance criteria and reported device performance related to AI/ML.
• Sample sizes, data provenance, expert ground truth establishment, or adjudication methods for an AI/ML test set.
• Information about MRMC studies, effect sizes of AI assistance, or standalone AI performance.
• Details about ground truth for training sets or their establishment for AI/ML.

The document discusses the following performance criteria for the dental cement:

1. Acceptance Criteria and Reported Device Performance (for the dental cement, not an AI device):

The document states that the flexural strength and film thickness tests of EsCem RMGI were conducted in accordance with ISO 9917-2. It also mentions that the technical data sheet of the predicate device (RelyX™ Luting Plus Automix) was referenced for these mechanical properties.

The report's conclusion is: "The flexural strength and film thickness test results of the subject device and predicate device meet the ISO 9917-2 requirements, and the values of those performances are comparable to those of the predicate device."

Without the actual numerical values from the "technical data sheet" or the "test results" for EsCem RMGI, a specific table cannot be created. The document only confirms compliance with the ISO standard and comparability.

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

The document does not specify sample sizes for the flexural strength and film thickness tests. It also does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, beyond stating that biocompatibility testing was performed in accordance with ISO 10993-1.

3. Number of Experts and Qualifications for Ground Truth:

This information is not applicable as the clearance is for a dental cement, not an AI device requiring expert consensus for image interpretation or diagnosis.

4. Adjudication Method:

This information is not applicable as the clearance is for a dental cement, not an AI device requiring adjudication of expert readings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable as the clearance is for a dental cement, not an AI device that assists human readers.

6. Standalone (Algorithm Only) Performance:

This information is not applicable as the clearance is for a dental cement, not an AI algorithm.

7. Type of Ground Truth Used:

For the dental cement's performance:

• Flexural Strength and Film Thickness: The "ground truth" or reference for performance is established by the ISO 9917-2 standard and comparison to the predicate device's technical data sheet. These are objective, measurable physical properties.
• Biocompatibility: Established by adherence to ISO 10993-1 and specific tests (in vitro cytotoxicity, skin sensitization, irritation testing).

8. Sample Size for the Training Set:

This information is not applicable as the clearance is for a dental cement, not an AI device with a training set.

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

This information is not applicable as the clearance is for a dental cement, not an AI device with a training set.

In summary, the provided FDA 510(k) clearance letter pertains to a dental cement and does not describe an AI/ML-powered device. Therefore, most of the requested information regarding AI device acceptance criteria, study design, and ground truth establishment is not present in this document.

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Final cementation of all-ceramic, metal-based inlays, onlays, posts, crown and bridge

EsCem is a dual-cured resin cement that can be self-etched and self-adhesive. It is classified as type 2 and class 3 according to ISO 4049. It is easy to handle with 'one step' system that does not need pre-treatment process, and it is easy to remove excess cement, so it is possible to perform quick operation. It is also easy to identify because it has a radio-opacity(1.2mm Al). And it offers various shades for aesthetics and color stable.

This document describes the performance testing for a dental cement called EsCem, manufactured by SPIDENT Co., Ltd. The purpose of the testing is to demonstrate the substantial equivalence of EsCem to a legally marketed predicate device, G-CEM LinkAce (K120243), manufactured by GC America Inc.

1. Acceptance Criteria and Device Performance

The performance testing was conducted according to various sections of the ISO 4049:2019, Dentistry Polymer-based restorative materials standard. The table below lists the acceptance criteria and the reported device performance for EsCem. Since specific numerical results for EsCem are not provided in the document (only whether it met the requirement), the "Reported Device Performance" column reflects that it met the acceptance criteria. For comparison, the document states that both the subject device and the predicate device meet the requirements of ISO 4049.

2. Sample Size for Test Set and Data Provenance

The document does not specify the exact sample sizes used for each performance test (e.g., number of specimens for film thickness, flexural strength, etc.). The provenance of the data is retrospective bench testing, conducted by SPIDENT Co., Ltd. in South Korea.

3. Number of Experts and Qualifications for Ground Truth

This study is a bench performance testing for a dental cement, not an AI/ML medical device. Therefore, the concept of "ground truth established by experts" in the context of interpretation (e.g., radiological reads) does not apply. The ground truth for this device is based on established international consensus standards (ISO 4049:2019) for physical and chemical properties of dental materials.

4. Adjudication Method for Test Set

Not applicable, as this is bench testing against a standard, not a human reader study requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a bench study comparing a new device against a standard and a predicate device's performance through physical and chemical property testing. It is not an MRMC study comparing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical dental device (cement), not an algorithm or software.

7. Type of Ground Truth Used

The ground truth used for this study is based on established industry standards, specifically ISO 4049:2019 (Dentistry Polymer-based restorative materials). This standard defines the acceptable ranges and properties for dental cements. Additionally, the comparison to a legally marketed predicate device (G-CEM LinkAce) serves as a comparative ground for substantial equivalence.

8. Sample Size for Training Set

Not applicable. This is a physical dental device subjected to bench testing, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no training set for this type of device.

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