3M VITREBOND LIGHT CURE GLASS IONOMER/BASE by 3M COMPANY

3M™ Vitrebond 114 Light Cure Glass Ionomer Liner/Base is indicated for lining and basing applications under composite, amalgam, ceramic, and metal restorations.

Device Description

3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base is comprised of a powder and a liquid component. The powder component is a light sensitive fluoro-aluminosilicate glass. The liquid component is a light sensitive polyalkenoic acid. The composition is a true glass ionomer exhibiting the major characteristics of glass ionomer products - it bonds to tooth structure, releases fluoride, and is a biocompatible material. Additionally, Vitrebond liner/base offers the unique combination of a prolonged working time with a very short set time achieved by exposure to light from a dental visible light curing unit. Polymerization by light exposure not only eliminates the set time waiting period common to auto set liners, it also provides enhanced mechanical and physical properties.

AI/ML Overview

This document is a 510(k) summary for a dental product (3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base). It describes the product, its intended use, and its substantial equivalence to predicate devices.

However, the provided text does not describe a study that uses acceptance criteria for a device's performance in terms of algorithms, AI, or diagnostic accuracy. It is focused on regulatory clearance for a dental material, highlighting its chemical composition, existing global usage, and substantial equivalence to other dental products.

Therefore, the requested information elements related to AI/algorithm performance, ground truth, expert opinions, sample sizes for test/training sets, and MRMC studies cannot be extracted from this text. The acceptance criteria described are implicitly related to the safety and effectiveness of a dental material through its chemical composition and historical usage, rather than algorithmic performance metrics.

To answer your request, I will explain why each point cannot be addressed based on the provided text.

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

Acceptance Criteria: Not explicitly stated in terms of performance metrics for an AI/algorithmic device. The acceptance criteria for this dental material are implicitly that it is safe and effective for its intended uses, as demonstrated by its chemical composition being virtually unchanged from a previously cleared device (Vitrabond, K882821) and its long-standing global usage with "excellent results."
Reported Device Performance: The text states, "The fact that this material has been used globally for years with excellent results confirms the fact that this material is safe and effective for its intended uses." This is a general statement about the material's performance in a clinical setting, but it lacks specific quantitative performance metrics relevant to an AI or diagnostic device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a "test set" in the context of evaluating an algorithm or diagnostic device. The "data" refers to real-world usage of the dental material, not a formal study with a defined test set.

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)

Not applicable. There is no mention of "experts" establishing a "ground truth" for a test set related to an AI or diagnostic device. The efficacy and safety are based on the material's chemical properties and historical clinical usage, not an expert panel reviewing cases.

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

Not applicable. There is no test set or adjudication process described.

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 is a dental material, not an AI-assisted diagnostic device, so an MRMC study is not relevant here.

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

Not applicable, as this is not an algorithm.

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

For this dental material, the "ground truth" for its safety and effectiveness is established through its chemical composition, biocompatibility testing (toxicology and histology data from K882821), and real-world clinical outcomes over years of global use. It's not a ground truth for a diagnostic task.

8. The sample size for the training set

Not applicable. There is no AI model or "training set" described.

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

Not applicable.

Summary

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3M Dental Products Laboratory

3M Center, Building 260-2B-09 St. Paul, MN 55 (44-1000) 612 733 3149

K9620065

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

JUL 18 1996

Name:	Amy E. FowlerSenior Regulatory Affairs Associate
Address:	3M Dental Products Laboratory3M Center, Building 260-2B-09St. Paul, MN 55144-1000
Phone:	(612) 736-1590
Fax:	(612) 736-0990
Date:	May 24, 1996
Trade Name:	3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base
Common Names:	cavity liner, lining cement, bonded base
Classification Name:	dental cement other than zinc oxide-eugenol(21 CFR 872.3275(b))
Predicate devices:	Vitrabond Light Cure Glass Ionomer Liner (K882821)Bisco Cavity Cleanser (K915668)Uni-Etch™ (part of One-Step Universal Dentin Adhesive)

3MM Vitrebond™ Light Cure Glass Ionomer Liner/Base has been changed very little since it was introduced globally over seven years ago. It is going through the 510(k) process now to add some labeling claims. In all other respects it is substantially equivalent to Vitrabond (K882821).

The toxiciology and histology data discussed in K882821 still applies, since the chemical composition is virtually unchanged. The fact that this material has been used globally for years with excellent results confirms the fact that this material is safe and effective for its intended uses.

3MTM Vitrebond™ Light Cure Glass Ionomer Liner/Base is substantially equivalent to the Bisco Cavity Cleanser (K915668) and Uni-Etch™ on the basis that they contact dentin and make a similar claim.

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.