IMICRYL Composite, Composite Flow Materials by IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS

IMICRYL Composite Materials include the brands Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo and Swarpe. IMICRYL Composite Materials; It is a light-cured, radiopaque, universal hybrid composite suitable for use in the anterior and posterior regions. It is packaged in a black syringe to protect it from light.

IMICRYL Flow Composite materials include the Nova Compo HF, Othocompo, Luxera and Maritza brands. IMICRYL Flow Composite materials; It is a light-cured hybrid radiopaque composite with a fluid consistency. Composite materials are a mixture of organic resin and inorganic filler. The resin matrix contains Bis-GMA and TEGDMA is added to decrease the viscosity.

There are differences in viscosity between composites and flowable composites.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for dental composite materials. It is not about an AI/ML-enabled medical device, diagnostic tool, or a study that assesses human performance with or without AI assistance. Therefore, it does not include information on acceptance criteria, expert adjudication, MRMC studies, standalone AI performance, or ground truth establishment in the context of AI/ML.

The document focuses on demonstrating the substantial equivalence of the IMICRYL Composite, Composite Flow Materials to a legally marketed predicate device (ProFil Composites). The acceptance criteria are implicit in the comparison tables, showing that the new device's performance characteristics are comparable to or meet the standards set by the predicate device and relevant ISO standards.

Here's an attempt to answer the questions based on the provided document, acknowledging its limitations regarding AI/ML:

1. A table of acceptance criteria and the reported device performance

The document compares the new device (IMICRYL Composite, Composite Flow Materials) against a predicate device (ProFil Composites) using various technological and non-clinical bench testing parameters. The "acceptance criteria" can be inferred as achieving values comparable to the predicate device, as the submission aims to prove substantial equivalence.

IMICRYL Composite Performance vs. Predicate Device (ProFil Composite)

Metric	IMICRYL Composite (Lot No: 17125)	ProFil Composite (Predicate)	Implied Acceptance Criteria (Comparable to Predicate)
Compressive Strength	420 MPa	440 MPa	Commensurate with ProFil (e.g., within a reasonable range of 440 MPa)
Flexural Strength	167 MPa	187 MPa	Commensurate with ProFil (e.g., within a reasonable range of 187 MPa)
Surface Hardness	265 MHV	285 MHV	Commensurate with ProFil (e.g., within a reasonable range of 285 MHV)
Water Sorption	16.8 µg/mm³	18.4 µg/mm³	Lower or comparable to ProFil
Water Solubility	0.3 µg/mm³	0.5 µg/mm³	Lower or comparable to ProFil
Polymerization Shrinkage	1.45 %	1.57 %	Lower or comparable to ProFil
Diametral Tensile Strength	31 MPa	30 MPa	Comparable to or higher than ProFil
Flexural Modulus	126.87 MPa	130 MPa	Commensurate with ProFil (e.g., within a reasonable range of 130 MPa)
Radiopacity	6 mm of Al	6.87 mm of Al	Commensurate with ProFil
Depth of Cure	2.5 mm	2.8 mm	Commensurate with ProFil
Elastic Modulus	16.8 GPa	17.1 GPa	Commensurate with ProFil
Intensity for Curing	1200 mW/cm2 – 10 sec, 500 mW/cm2 – 20 sec	1200 mW/cm2 – 10 sec, 500 mW/cm2 – 20 sec	Same as ProFil
Wavelength for Curing	470 nm	470 nm	Same as ProFil
Filler Particle Size Dist.	0.7 μm	0.7 μm	Same as ProFil
Working Time	38 second	35 second	Comparable to ProFil
Setting Time	4 minute	4 minute 10 second	Comparable to ProFil
Curing Time	20 second	20 second	Same as ProFil

IMICRYL Composite Flow Performance vs. Predicate Device (ProFil Composite Flow)

Metric	IMICRYL Composite Flow (Lot No: 17126)	ProFil Composite Flow (Predicate)	Implied Acceptance Criteria (Comparable to Predicate)
Compressive Strength	380 MPa	370 MPa	Comparable to or higher than ProFil Flow
Flexural Strength	165 MPa	160 MPa	Comparable to or higher than ProFil Flow
Surface Hardness	265 MHV	285 MHV	Commensurate with ProFil Flow
Water Sorption	16.8 µg/mm³	18.4 µg/mm³	Lower or comparable to ProFil Flow
Water Solubility	0.3 µg/mm³	0.5 µg/mm³	Lower or comparable to ProFil Flow
Polymerization Shrinkage	2.2 %	2 %	Comparable to ProFil Flow
Diametral Tensile Strength	68 MPa	65 MPa	Comparable to or higher than ProFil Flow
Flexural Modulus	126.87 MPa	130 MPa	Commensurate with ProFil Flow
Radiopacity	3.5 mm of Al	3 mm of Al	Comparable to or higher than ProFil Flow
Depth of Cure	3.8 mm	3 mm	Comparable to or higher than ProFil Flow
Elastic Modulus	16.8 GPa	17.1 GPa	Commensurate with ProFil Flow
Intensity for Curing	1200 mW/cm² - 10 sec, 500 mW/cm² – 20 sec	1200 mW/cm² - 10 sec, 500 mW/cm² – 20 sec	Same as ProFil Flow
Wavelength for Curing	470 nm	470 nm	Same as ProFil Flow
Filler Particle Size Dist.	0.7 μm	0.7 μm	Same as ProFil Flow
Working Time	38 second	35 second	Comparable to ProFil Flow
Setting Time	4 minute	4 minute 10 second	Comparable to ProFil Flow
Curing Time	20 second	20 second	Same as ProFil Flow

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 refers to "bench tests" and does not specify sample sizes (e.g., number of specimens for each test like compressive strength). It implies in-house testing was performed for the IMICRYL products to generate the reported data. The country of origin for the data generation (testing) would likely be Turkey, where the manufacturer (IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.) is located. These are laboratory-based, non-clinical tests, not human subject data.

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 question is not applicable to this type of device submission. There were no human experts establishing "ground truth" as it relates to image interpretation or clinical outcomes. The "ground truth" for material properties is established by adherence to recognized international standards (e.g., ISO 4049, ISO 17304) and laboratory testing methodologies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is a non-clinical bench testing submission, not an clinical study requiring expert adjudication of data.

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 restorative material, not an AI-enabled diagnostic device. No MRMC study was performed.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission are the physical, mechanical, and biological properties of the material, measured through standardized non-clinical bench tests (e.g., compressive strength, flexural strength, biocompatibility tests). These measurements are quantifiable and objective, not dependent on expert consensus, pathology, or outcomes data in the way medical imaging AI devices are. The "truth" is established by laboratory measurements according to ISO standards.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set and thus no ground truth established for one.

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.