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Fusion Core DC Flo is indicated for use as core build up material on vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material, and as a dentin replacement material.

Fusion Flo is indicated for direct filling of class V (cervical caries, root erosions, and wedge shaped defects), anterior restorations( Class III and IV), small posterior restorations, repair of composite/ceramic veneers, and blocking out of undercuts.

Fusion Flo SE is indicated for direct filling of class V (cervical caries, root erosion, wedge shaped defects), anterior restorations (Class III and IV), small posterior restorations,

Fusion I-Seal is indicated for Class I and Class II restorations, as a liner under composite restorations, and as a pit and fissure sealant.

Magma NT is indicated for direct restoration in anterior and posterior teeth classes I, III, IV and V, and porcelain/ composite repairs.

Device Description

Fusion Core DC Flo is dual-curing, radiopaque, flowable restoration for core build-up composite supplied in an auto-mix delivery system.

Fusion Flo is a flowable composite of medium viscosity used for fillings in anterior teeth and small fillings in posterior teeth. Fusion Flo can be used separately or with Magma-NT composites.

Fusion Flo SE is a self-etch, self-adhesive flowable composite. The flowable composite is ready for use and doesn't require the preparatory steps of etching, priming and bonding. Fusion Flo SE can be used separately or with Magma-NT composites.

Fusion I-Seal is a single component, light cured flowable composite.

Magma-NT is a visible light cured, radio opaque highly filled hybrid composite restorative material for anterior and posterior restoration of all teeth.

AI/ML Overview

The provided text describes the acceptance criteria and performance of several dental composite resins from Prevest Denpro Limited (Fusion Core DC Flo, Fusion Flo SE, Fusion I-Seal, and Magna NT) as part of a 510(k) premarket notification to the FDA. The study aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting the requirements of ISO 4049:2019 and ISO 13116:2014, with specific values mentioned for some parameters. The reported device performance indicates that "All test results met the criteria in standards."

Device Property	Acceptance Criteria (Standard / Value)	Reported Device Performance
Fusion Core DC Flo	Based on ISO 4049:2019 & ISO 13116:2014	Met criteria in standards. Specific values for Flexural Strength (≥50 MPa), Radio Opacity (3mm compared with aluminium wedge), Water Sorption (maximum of 40 µg/mm³), Water Solubility (maximum of 7.5 µm/mm³), Working Time (1:25), Setting Time (3:20).
Fusion Flo	Based on ISO 4049:2019 & ISO 13116:2014	Met criteria in standards. Specific values for Flexural Strength (≥ 80 MPa), Depth of Cure (1.00 mm opaque / 1.5 mm others minimum), Radio Opacity (3mm compared with aluminium wedge), Water Sorption (≤40 µg/mm³), Water Solubility (maximum of 7.5 µm/mm³).
Fusion Flo SE	Based on ISO 4049:2019 & ISO 13116:2014, USP 971 (for pH)	Met criteria in standards. Specific values for Flexural Strength (≥ 80 MPa), Depth of Cure (1.00 mm opaque / 1.5 mm others minimum), Radio Opacity (3mm compared with aluminium wedge), Water Sorption (

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K Number

K123631

Device Name

MFP-051

Manufacturer

GC AMERICA, INC.

Date Cleared

2013-07-23

(242 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K082434,K091388,K032921,K042819

Intended Use

Direct restorative for class I, II, III, IV, V cavities.
Direct restorative for wedge-shaped defects and root surface cavities.
Direct restorative for veneers and diastema closure.

Device Description

MFP-051 is a light-cured, nano-filled radiopaque composite resin filled in either a syringe or unitip. The device is a universal type. The material is available in 17 shades. The device is used for the restorations of both anterior and posterior teeth.

AI/ML Overview

The provided document is a 510(k) summary for a dental restorative material (MFP-051). It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria in a clinical or simulated clinical setting. As such, most of the requested information regarding acceptance criteria and performance studies is not available in this document.

Here is a breakdown of the information that can be extracted or deduced from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Test	Acceptance Criteria (Implied by ISO 4049)	Reported Device Performance	Assessment
Substantial Equivalence	Equivalent to predicate devices in function, principle, technology, safety, and intended use.	"The curing mechanism of the new and predicate devices is substantially equivalent... in function, and similar in principle, increr (sic), and intended use. This supports that the compatibility and safety of the applicant device are substantially equivalent to the predicate devices."	Met
Material Properties (Implied by ISO 4049 and predicate comparison)	Flexural strength, water sorption, and solubility should be equivalent to predicate devices.	"The applicant device also shows equivalence in flexural strength, water sorption and solubility, which indicate the stability of materials in oral environment."	Met
Mechanical/Physical Properties	Compliance with ISO 4049:2009 (Dentistry - Polymer-based restorative materials).	"The applicant device complies with all the requirements of ISO 4049: 2009..."	Met
Components	Components should be previously used in predicate devices or generally accepted for dental materials.	"All the components of the applicant device, MFP-051, have already been used in the predicate devices."	Met
Indications for Use	Similar to predicate devices.	Proposed indications are direct restorative for Class I, II, III, IV, V cavities, wedge-shaped defects and root surface cavities, veneers, and diastema closure, which are consistent with predicate device indications.	Met

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

Not explicitly stated in the document. The document refers to meeting ISO standards and equivalence, implying testing was done, but details about the sample size, test methods, or data provenance (e.g., country of origin, retrospective/prospective) are not provided for specific performance tests. This submission relies on demonstrating compositional and functional similarity to already cleared devices and compliance with an international standard.

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

Not applicable. This document does not describe a study involving expert assessment or "ground truth" establishment in the context of clinical or diagnostic performance. The evaluation is based on material properties and regulatory standards.

4. Adjudication method for the test set:

Not applicable. See point 3.

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 device is a dental restorative material, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This is a physical dental material, not an algorithm.

7. The type of ground truth used:

For the material properties (flexural strength, water sorption, solubility), the "ground truth" would be established by validated laboratory testing methods against the requirements of ISO 4049:2009.
For the claim of "substantial equivalence" of components and indications, the ground truth is the characterization of the predicate devices and their established safety and effectiveness.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable. See point 8.

In summary:

This 510(k) submission for MFP-051 demonstrates substantial equivalence by showing that the device complies with ISO 4049:2009, contains components already used in predicate devices, and shows equivalence in key material properties (flexural strength, water sorption, solubility) to similar legally marketed devices. It does not contain details of specific clinical performance studies with acceptance criteria, sample sizes, or expert adjudication as would be relevant for a diagnostic or AI device. The "acceptance criteria" primarily revolve around meeting an international standard (ISO 4049) and demonstrating technical and functional similarity to predicate devices.

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