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510(k) Data Aggregation

    K Number
    K102621
    Device Name
    SOLSTICE
    Manufacturer
    KERR CORPORATION
    Date Cleared
    2011-01-28

    (137 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K052063
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Solstice is for the polymerization of light-cured materials by dental professionals.

    Device Description

    The Solstice is a Light Emitting Diode (LED) visible light used for the polymerization of light-cured materials by dental professionals. The Solstice consists of an LED curing handpiece and a charging system. The plastic molded handpiece contains an LED light engine, battery, and printed circuit board containing the electronics. A digital circuit and microprocessor will be utilized to control two (2) different curing modes (10 and 20 seconds). Each mode specifies LED curing output and audible beep timing. The Solstice uses a single pushbutton trigger to activate the LED curing output and select the curing mode.

    AI/ML Overview

    This document describes the Solstice LED Curing Light, identified by K102621, and its substantial equivalence to the predicate device, Kerr Corporation's Demi. The device is intended for the polymerization of light-cured materials by dental professionals.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text does not explicitly state quantitative acceptance criteria or a direct comparison table for performance metrics between the Solstice and the predicate device. However, it mentions specific performance aspects for which data was submitted to demonstrate substantial equivalence.

    Performance MetricAcceptance Criteria (Implicit)Solstice PerformanceStudy/Proof
    BiocompatibilityNon-toxic, non-irritatingRepresentative resin (similar to handle material) passed biocompatibility tests.Statement from component manufacturer.
    Depth of CureComparable to predicate deviceData included in submission demonstrating performance compared to predicate.Non-Clinical Test Data
    IrradianceAppropriate light intensity and peak wavelength for curing dental materialsData included showing light intensity and peak wavelength.Non-Clinical Test Data
    Software ValidationSoftware functions as intendedSuccessfully validated.Non-Clinical Test Data
    Thermal ManagementDoes not require a cooling fan (i.e., operates within acceptable temperature limits without external cooling)Temperature data demonstrated no cooling fan needed.Non-Clinical Test Data
    Light Output StabilityConstant light output during curing (unlike predicate which has shifting output)Emits a constant light output.Device Description / Non-Clinical Test Data

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

    The document does not specify a distinct "test set" in the context of machine learning or AI. Instead, it refers to non-clinical tests conducted on the device itself or representative materials.

    • Biocompatibility: "samples from typical production lots of the resin" were tested. No specific number is given.
    • Depth of Cure, Irradiance, Thermal Management: Data was generated from testing the Solstice device. The sample size (number of devices, number of measurements) is not provided.
    • Data Provenance: All data appears to be prospective and generated by Sybron Dental Specialties Inc. or its component manufacturers in the United States (Orange, CA, where the submitter is located).

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

    Not applicable. This device is a medical instrument, not an AI/ML product where expert-established ground truth for a test set would be relevant. The performance evaluation is based on objective physical and chemical measurements.

    4. Adjudication Method for the Test Set

    Not applicable. As noted above, this relates to expert review of data for AI/ML models, which is not relevant here.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

    Not applicable. This is a medical device, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was conducted.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    Not applicable. This device is a physical instrument, not an algorithm.

    7. The Type of Ground Truth Used

    For the non-clinical tests:

    • Biocompatibility: The "ground truth" is established by standard biocompatibility testing protocols, with the definition of "passing" those tests serving as the benchmark.
    • Depth of Cure, Irradiance, Thermal Management: The "ground truth" is derived from direct physical measurements of the device's output and behavior, and comparison against established scientific/engineering principles for effective light curing and safety, as well as comparison to the predicate device's known performance.
    • Software Validation: The "ground truth" is defined by the software requirements and specifications, with successful validation meaning the software performs according to these predefined criteria.

    8. The Sample Size for the Training Set

    Not applicable. This device does not involve machine learning and therefore does not have a "training set."

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. See #8.

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