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K Number
K990108
Device Name
LC FLOWFILL
Manufacturer
S & C POLYMER GMBH
Date Cleared
1999-03-09

(55 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

LC FLOWFILL is a flowable light current micro hybride composite for tooth r fillings, sealings and cementing.

Device Description

LC FLOWFILL material which can be used as LC FLOWFILL material.

AI/ML Overview

This is a 510(k) premarket notification for a dental material (LC FLOWFILL). The provided text describes the regulatory clearance process rather than a study evaluating the performance of an AI-powered device. Therefore, most of the requested information regarding acceptance criteria and a study proving a device meets these criteria is not applicable.

Here's an assessment based on the provided text:

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

    • Not Applicable. The submission is for a dental filling material, not an AI-powered device with performance metrics like sensitivity or specificity. The "acceptance criteria" here refer to regulatory requirements for demonstrating substantial equivalence to a predicate device, rather than performance metrics of an AI algorithm.

  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. This information pertains to studies validating AI device performance, which is not present in the provided document. The submission focuses on chemical composition and intended use comparison.

  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. Ground truth establishment by experts for a test set is relevant for AI performance evaluation. This document describes a traditional medical device (dental filling material).

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

    • Not Applicable. Adjudication methods are used in studies involving expert reviews, typically for AI validation, which is not the subject of this document.

  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. MRMC studies are designed for evaluating the impact of AI on human reader performance, which doesn't apply to a dental filling material.

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

    • Not Applicable. This applies to AI devices, not a dental filling material.

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

    • Not Applicable. For a dental filling material, "ground truth" would relate to material properties and clinical performance (e.g., strength, biocompatibility, longevity). The submission asserts substantial equivalence based on chemical composition and intended use rather than providing specific performance data validated against a clinical ground truth.

  8. The sample size for the training set

    • Not Applicable. This is relevant for AI model training, not for a traditional medical device like a dental filling material.

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

    • Not Applicable. As above, this applies to AI model development.

Summary based on the provided text:

The provided document is a 510(k) summary for a dental filling material called LC FLOWFILL. The primary objective is to demonstrate substantial equivalence to a predicate device, "FLOW IT" by Pentron USA.

  • Acceptance Criteria (Regulatory perspective): The main "acceptance criterion" for this submission is demonstrating that LC FLOWFILL is substantially equivalent to a legally marketed predicate device in terms of intended use, performance, indications, labels, and instructions for use.
  • Study Proving Acceptance Criteria: The "study" isn't a clinical trial or AI validation study in the typical sense. Instead, the manufacturer (S & C Polymer GmbH) asserts substantial equivalence based on:
    • Chemical composition comparison: Stating that "The chemical composition and use of LC FLOWFILL material is substantially equivalent to 'FLOW IT'." (Page 1)
    • Intended use, performance, indications, labels, and instructions for use comparison: Stating that these aspects are "substantially similar to the predicted device." (Page 1)

The FDA's letter confirms that they have "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This FDA determination serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance.

In essence, the document is a regulatory filing for a conventional medical device, and therefore the modern AI-centric questions are not applicable to its contents.

§ 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.