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510(k) Data Aggregation
(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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