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510(k) Data Aggregation
(248 days)
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.
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.
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 (<40 µg/mm³), Water Solubility (maximum of 7.5 µm/mm³). |
| Fusion I-Seal | Based on ISO 4049:2019 & ISO 13116:2014 | Met criteria in standards. Specific values for Flexural Strength (≥ 25 MPa), Depth of Cure (1.5 mm minimum), Radio Opacity (3mm compared with aluminium wedge), Water Sorption (≤40 µg/mm³), Water Solubility (maximum of 7.5 µm/mm³). |
| Magma NT | Based on ISO 4049:2019 & ISO 13116:2014 | Met criteria in standards. Specific values for Flexural Strength (≥ 80 MPa), Depth of Cure (2.59 mm opaque / 2.89 mm non-opaque), Radio Opacity (3mm compared with aluminum wedge), Water Sorption (≤40 µg/mm³), Water Solubility (maximum of 7.5 µm/mm³). |
| Shelf Life (all composites) | Testing protocols based on ISO 4049:2019 | Shelf life of 3 years (except Fusion Core DC Flo: 2 years). Determinations use the same testing protocols and met the criteria. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the test sets for each specific test (e.g., flexural strength, water sorption). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer, Prevest Denpro Limited, is based in India, so it's possible the testing was conducted there, but this is not confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable to this type of device and study. The "ground truth" for dental composite resins is established through objective physical and chemical testing against international standards (ISO standards), rather than expert interpretation of images or clinical outcomes that require human assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, the "truth" is determined by objective laboratory measurements against predefined standards.
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 study concerns the physical and chemical properties of dental composite resins, not an AI-powered diagnostic device requiring evaluation of human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for evaluating these dental composite resins is defined by international standard specifications for physical and chemical properties as outlined in ISO 4049:2019 (Dentistry - Polymer-based restorative materials) and ISO 13116:2014 (Dentistry - Dental impression materials - Radiopacity). For Fusion Flo SE, USP 971 was also referenced for pH testing. The "truth" is whether the measured properties of the device meet the quantitative limits set by these standards.
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. As this is not an AI device, there is no training set or ground truth established in that context.
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(242 days)
- 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.
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.
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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