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Class I to Class V restorations Core build up

The subject Surefil one™ Self-adhesive Composite Hybrid is an self- adhesive dental restorative material which is intended to be used as a restorative filling material for direct restorations. The "composite hybrid" composition of the subject device is based on resin-modified glass ionomer chemistry and is provided in a powder/liquid formulation in a mixing capsule.

The subject Surefil one™ Self-adhesive Composite Hybrid offers is available in multiple shades and exhibits the following features:

• Self-adhesiveness to enamel and dentin
• Fluoride release
• Bulk fill and dual-cure
• Radiopacity (equivalent to 2mm aluminum).

The provided text describes the Dentsply Sirona Surefil one™ Self-adhesive Composite Hybrid, a dental restorative material, and its substantial equivalence determination by the FDA based on non-clinical performance data.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each test. Instead, it states that the performance "satisfactorily met the requirements" and that the device "conforms to the requirements" of the standards. The reported device performance is presented as meeting these standards.

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

The document states that "In-vitro bench tests were performed" and "Comparartive tests were performed between the proposed Surefil one™ Self-adhesive Composite Hybrid and the predicate device (K130223)". However, the specific sample sizes used for each test are not provided in this document. The data provenance is described as non-clinical in-vitro bench tests conducted by Dentsply Sirona, referencing ISO 9917-2:2017 and EN ISO 10993-1. There is no information about country of origin of the data beyond "internal Dentsply Sirona criteria". The data is prospective for the purpose of this submission (i.e., new tests were performed).

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

Since this study involves non-clinical in-vitro bench testing of physical and chemical properties of a dental restorative material, the concept of "experts used to establish ground truth" as it would apply to diagnostic imaging or clinical decisions is not directly applicable. The "ground truth" for these tests is based on established international standards (ISO, EN ISO) and internal company criteria, which are derived from scientific principles and industry best practices for material characterization. No information on human experts establishing ground truth for these in-vitro tests is provided.

4. Adjudication Method for the Test Set

As explained above, since the study involves non-clinical in-vitro bench testing, an adjudication method for human-read interpretations is not applicable or mentioned. The results of these tests are objective measurements against predefined criteria/standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical bench study comparing the physical and chemical properties of the device against a predicate and established standards, not an evaluation of human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone study was done in the sense that the device's performance was evaluated independently through in-vitro bench tests. This refers to the algorithm/device itself (the dental material in this case) and its intrinsic properties, without human-in-the-loop performance measurement.

7. Type of Ground Truth Used

The ground truth used for the non-clinical tests is based on scientific measurement against established international standards (e.g., ISO 9917-2:2017, EN ISO 10993-1) and internal Dentsply Sirona criteria. This is essentially an objective, measured characteristic rather than an expert consensus, pathology, or outcomes data in the traditional medical device sense.

8. Sample Size for the Training Set

This document describes a premarket notification for a physical medical device (dental restorative material), not an AI/ML-driven device that requires training data. Therefore, the concept of a "training set" and its sample size is not applicable to this submission.

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

As stated above, a training set is not applicable to this type of device.

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• -Cementation of metal-based inlays, onlays, crowns and bridges
• -Cementation of resin inlays, onlays, crowns and bridges
• Cementation of all ceramic inlays -
• -Cementation of high strength (e.g. zirconia based, lithium disilicate) ceramic onlays, crowns and bridges
• Cementation of metal, ceramic and fiber posts -

GC FujiCEM 2 (Improved) is a resin modified glass ionomer luting cement. The device is composed of the two pastes, Paste A and Paste B, packaged in an automix dual barrel syringe.

The provided document is a 510(k) summary for a dental cement (GC FujiCEM 2 (Improved)). It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about software or AI-based devices. Therefore, a table of acceptance criteria and reported device performance for an AI/software device cannot be generated from this text.

The document discusses the physical and chemical properties of the dental cement through performance bench tests and biocompatibility assessments against established ISO standards.

Here's an analysis of the available information regarding the device's evaluation, although it's for a physical dental cement product, not an AI device:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Software):

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

• Not applicable for AI/Software. The document describes non-clinical bench testing. The sample sizes for each specific test (e.g., number of specimens for flexural strength) are not explicitly stated within this summary. Data provenance is implied to be from the manufacturer's own testing.

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

• Not applicable for AI/Software. Ground truth for dental cement properties is established through standardized physical and chemical testing methods, not expert consensus in the way it's used for AI diagnostic outputs.

4. Adjudication method for the test set:

• Not applicable for AI/Software. The performance criteria for the dental cement are objective metrics measured by equipment and standardized procedures, not subjective interpretations requiring adjudication.

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:

• Not applicable. This document is for a dental cement, not an AI or software device.

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

• Not applicable. This is a physical medical device (dental cement), not an algorithm or software. No standalone algorithm performance was assessed.

7. The type of ground truth used:

• For biocompatibility: Ground truth is defined by the criteria and methods outlined in ISO 10993 series standards.
• For performance bench tests: Ground truth is defined by the specifications and methods in ISO 9917-2: 2017 (Dentistry - Water-based cements - Part 2: Resin-modified cements) and the company's internal standards. These are objective, measurable physical and chemical properties.

8. The sample size for the training set:

• Not applicable. This is a physical medical device. There is no training set in the context of AI/machine learning.

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

• Not applicable. See point 8.

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