Renamel Microfill by Cosmedent, Inc

Renamel® Microfill is light-cured, microfilled, highly polishable dental restorative material. According to the applicable FDA recognized consensus standard ISO 4049 - "Dentistry -Polymer-based restorative materials", this device is classified as Type 1, Class 2, Group 1: Polymer-based restorative materials, involving occlusal surfaces, which uses external energy source for intra-orally curing. Renamel® Microfill consists of multi-functional acrylic Resin and fillers of 0.04 - 0.2 micron sized particles of inorganic and prepolymerized composite (70% by weight, 60% by volume). These devices possess physical and mechanical properties that allow them to function in the oral cavity with esthetic quality that mimics natural enamel surface.

AI/ML Overview

This document describes the premarket notification for the Renamel® Microfill dental restorative material. The acceptance criteria and supporting study details are primarily focused on the physical and mechanical properties of the material, demonstrating its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

Property / Standard	Specification (Acceptance Criteria)	Renamel® Microfill Performance (Reported Device Performance)
Depth of cure (other than opaque materials) ISO 4049:2009; Type1, Class2, Group1	≥ 1.5mm	2.15 mm ± 0.1mm
Flexural strength ISO 4049:2009; Type1, Class2, Group1	≥ 80 MPa	95.5 MPa ± 3 MPa
Water sorption ISO 4049:2009; Type1, Class2, Group1	≤ 40 µg/mm³	15 µg/mm³ ± 0.5 µg/mm³
Solubility ISO 4049:2009; Type1, Class2, Group1	≤ 7.5 µg/mm³	0.9 µg/mm³
Radiopacity ISO 4049:2009; Type1, Class2, Group1	≥ 1mm (Not claimed by applicant)	None (not claimed)
Compressive strength	≥ 320 MPa	410 MPa ± 40 MPa
Modulus of elasticity	≥ 3000 MPa	5100 MPa ± 300 MPa

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

The document does not explicitly state the sample size used for each specific test (e.g., number of specimens for depth of cure, flexural strength, etc.). However, it does refer to the ISO 4049:2009 standard for testing polymer-based restorative materials, which would inherently dictate the sample sizes required for statistically sound testing. The data provenance is not specified, but it can be inferred that these are in-house laboratory tests conducted by Cosmedent, Inc. or a contracted testing facility to comply with the referenced ISO standard. The data is retrospective in the context of this submission, meaning the tests were performed before the submission to demonstrate compliance.

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

This information is not applicable to this document. The "ground truth" for the performance criteria of a dental restorative material is established through objective, standardized physical and mechanical property testing according to international standards (ISO 4049). It does not involve expert consensus in the same way clinical diagnostic studies might.

4. Adjudication Method for the Test Set:

This information is not applicable to this document. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For material property testing, the results are typically quantitative measurements.

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:

This information is not applicable to this document. MRMC studies are relevant to diagnostic devices involving human interpretation of medical data, often with AI assistance. This document pertains to a dental restorative material, which is not a diagnostic device and does not involve "human readers" in the context of interpretation.

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

This information is not applicable to this document. This refers to the performance of an AI algorithm independently. The Renamel® Microfill is a physical dental material, not an AI algorithm.

7. The Type of Ground Truth Used:

The ground truth used for demonstrating compliance is based on objective, quantitative measurements of physical and mechanical properties derived from standardized laboratory tests as defined by ISO 4049:2009 and other general material testing standards (e.g., for compressive strength and modulus of elasticity). This is equivalent to established scientific and engineering standards for material performance.

8. The Sample Size for the Training Set:

This information is not applicable to this document. "Training set" refers to data used to train machine learning models. The Renamel® Microfill is a physical product, and its development and testing do not involve machine learning training in this context.

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

This information is not applicable for the same reason as point 8.

Summary

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.