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    K Number
    K022959
    Device Name
    SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1
    Manufacturer
    MDC RESEARCH LTD.
    Date Cleared
    2003-02-05

    (152 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K913573
    Why did this record match?
    Reference Devices :

    K913573

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SafeStep™ Safety Dental Cartridge Injector is a sterile, single use disposable injector barrel assembly and a reusable plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges and existing screw-on dental needles for injection of anesthetic solution in oral tissues. The SafeStep™ Safety Dental Cartridge Injector aids in the prevention of needle stick injuries. The SafeStep™ Safety Dental Cartridge Injector incorporates a needle retraction and re-advancing mechanism which may be operated with one hand.

    Device Description

    The SafeStep™ Safety Dental Cartridge Syringe consists of a single-use, disposable aspirating syringe-type injector with a separate re-usable plunger assembly indicated for the use in delivering dental anesthetics. The SafeStep™ Safety Dental Cartridge Syringe incorporates a needle safety mechanism that can be activated with one hand.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the SafeStep™ Safety Dental Cartridge Injector:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Stated or Implied)Reported Device Performance
    Primary Safety Criterion: Zero prevalence of sharp injuries during use.Met. The simulated use clinical study reported "zero prevalence of sharp injuries" for the MDC SDCI.
    Primary Safety Criterion: Zero failures of the safety protection feature that could lead to a sharps injury.Met. The simulated use clinical study reported "no failures of the protection feature of the device that could reasonably lead to a sharps injury."
    Equivalency to Predicate Device (Septodont Safety Plus) in Performance.Met. The simulated use study demonstrated that the MDC SDCI is "equivalent to the Septodont Safety Plus predicate device in terms of performance and evaluator preference."
    Non-clinical performance testing also concluded the device was "acceptable in all test cases" and "equivalent to the Septodont Safety Plus in terms of materials, function and intended use."
    Biocompatibility in accordance with ISO standards.Met. "The results of the biocompatibility tests, including cytotoxicity, sensitization and acute intracutaneous reactivity, were found to be acceptable."
    Sterilization validation to ANSI/AAMI/ISO 11137-1999 (Method 1).Met (Certification). MDC Research "certifies that the SafeStep™ Safety Dental Cartridge Injector will pass ANSI/AAMI/ISO 11137-1994, Method 1 validation prior to marketing of the device." (Note: This is a certification of future compliance rather than a direct report of a completed validation for the specific submission, but it's presented as an assurance.)
    Functional Attributes: Thermal stress, functional attribute, injection force, compression/tension loading before and after retraction, release force, leakage/splatter, aspiration testing.Met. "The results of the performance evaluations of the SafeStep™ Safety Dental Cartridge Injector were found to be acceptable in all test cases."

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

    • Sample Size: Not explicitly stated in the provided text. The study is described as a "simulated use clinical study."
    • Data Provenance: The study was conducted by "MDC Research Ltd." The text does not specify the country of origin of the data or the participants, nor does it explicitly state if the data was retrospective or prospective. Given it's a "simulated use clinical study," it would inherently be prospective in nature, as new data would be generated.

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

    • Number of Experts: Not explicitly stated. The study involved "evaluator preference," implying multiple evaluators, but their number and specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not explicitly stated. The text mentions "evaluator preference" and a comparison of performance, but it doesn't describe the process of resolving discrepancies or establishing a consensus "ground truth" if multiple evaluators were involved.

    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

    • No Multi-Reader Multi-Case (MRMC) Study was performed. This device is a manual medical device (a dental cartridge injector), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable. The study compared the device's performance to a predicate device in a simulated clinical setting.

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

    • No Standalone (algorithm only) study was done. This is a physical medical device. The "simulated use clinical study" inherently involved humans interacting with the device, making it an "algorithm with human-in-the-loop performance" in a metaphorical sense, as the device's mechanism (the "algorithm") is activated and operated by a user.

    7. The Type of Ground Truth Used

    The "ground truth" for the simulated use clinical study revolved around:

    • Observed Safety Outcomes: Zero prevalence of sharp injuries and zero failures of the protection feature that could lead to sharps injury. This is based on direct observation and recording within the simulation.
    • Performance Equivalency and Evaluator Preference: This would be based on subjective and objective assessments made by the evaluators/participants of the simulated use study, comparing the device to the predicate.

    8. The Sample Size for the Training Set

    • Not Applicable. This device is a mechanical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. Design and functional testing would have been done during its development, but these are not "training sets."

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

    • Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.
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