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    K Number
    K043408
    Device Name
    PIEZOSURGERY DEVICE
    Manufacturer
    PIEZOSURGERY SRL
    Date Cleared
    2005-06-08

    (180 days)

    Product Code
    DZI
    Regulation Number
    872.4120
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K042434
    Why did this record match?
    Device Name :

    PIEZOSURGERY DEVICE

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

    The Piezosurgery device is a bone cutting instrument intended for use in oral surgery.

    Device Description

    The Piezosurgery® device uses piezoelectric ultrasonic technology to generate mechanical The riezdsurgery done cutting, with minimal trauma to soft tissue. The device is supplied mith sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery and surgical orthodontics.

    AI/ML Overview

    The Piezosurgery device, indicated as a bone cutting instrument for oral surgery, underwent performance evaluations primarily based on clinical and histologic data.

    Here's an analysis of the provided information in the requested format:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Inferred from Performance Evaluations)Reported Device Performance
    Incision Characteristics: Desired cutting action achieved with limited pressure.The evaluations "demonstrated the desired cutting action and the need for limited pressure on the handpiece to achieve the desired cutting action."
    Cutting Precision: Precise osteotomies.The technology "has been shown to allow precise osteotomies."
    Surgical Tactile Control: Adequate control.Evaluated. (Specific performance metric not detailed, but implied to be acceptable)
    Risk of Adjacent Tissue Damage: Minimal trauma to soft tissue."Minimal trauma to soft tissue." The technology "has been shown to allow precise osteotomies with minimal risk of tissue heating and osteonecrosis damage." Implied minimal risk to soft tissue due to the inherent nature of piezoelectric cutting.
    Mineralized Tissue Heating: Minimal heating."Minimal risk of tissue heating."
    Integrity of Osteotomized Surfaces: Good integrity."Integrity of the osteotomized surfaces." (Evaluated. Specific performance metric not detailed, but implied to be acceptable)
    Post-operative Healing: Effective healing."The operative healing." (Evaluated. Specific performance metric not detailed, but implied to be acceptable)
    Safety: Overall safety profile acceptable."Performance and safety evaluations were based on clinical and histologic data." "The performance and safety data presented in this premarket notification support a finding of substantial equivalence."

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

    • Sample Size: Not explicitly stated. The document refers to "clinical and histologic data," implying a study involving patients or tissue samples, but no specific numbers are provided for either human subjects or tissue samples.
    • Data Provenance: Not explicitly stated. The clinical and histologic data are likely retrospective, as no prospective study design is mentioned. The country of origin is not specified, but the submitter and contact person are associated with Italy, suggesting the data could be from Italy or Europe, though this is not confirmed.

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

    • Number of Experts: Not specified.
    • Qualifications of Experts: Not specified.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not specified. There is no mention of a formal adjudication process (e.g., 2+1, 3+1).

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

    • MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned. The evaluation focuses on the device's intrinsic performance characteristics rather than comparing human reader performance with and without AI assistance. This device is a surgical tool, not an AI diagnostic system.

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

    • Standalone Performance: Not applicable. This device is a manual surgical instrument, not an algorithm or AI system. Its performance inherently involves a human operator.

    7. The Type of Ground Truth Used

    • Ground Truth Type: Clinical observations and histologic findings. These are considered direct evidence of the device's effects on tissue and surgical outcomes.

    8. The Sample Size for the Training Set

    • Sample Size: Not applicable. As this is a medical device and not an AI or machine learning model, there is no "training set" in the conventional sense. The "training" for such devices typically involves design, engineering, and iterative testing, sometimes using preclinical or basic science data, and ultimately clinical data serves as validation.

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

    • Ground Truth Establishment: Not applicable, as there is no training set mentioned for an algorithm. The development of the device would have relied on engineering principles, material science, and possibly cadaveric or animal studies to refine its design and operational parameters.
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