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    K Number
    K150796
    Device Name
    Dental Bone Cutting Instruments
    Manufacturer
    SYNTHES (USA) PRODUCTS, LLC
    Date Cleared
    2015-06-23

    (89 days)

    Product Code
    DZJ
    Regulation Number
    872.4120
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K123270,K082649
    Why did this record match?
    Device Name :

    Dental Bone Cutting Instruments

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

    The Dental Bone Cutting Instruments are nonpowered hand-held for trauma, reconstruction, or orthognathic procedures to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw.

    Device Description

    Dental bone cutting instruments are taps and countersinks. Countersinks are used to create a countersink feature in bone to provide a contact surface for screw heads and to reduce the palpability of the screw head. Taps are used to create threads in a pre-drilled hole in order to accommodate a bone screw. The taps and countersinks are manufactured from Stainless Steel 440A in accordance with ASTM F899 Standard Specification for Stainless Steel for Surgical Instruments as well as ASTM A276 Specification for Stainless Steel Bars and Shapes.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Dental Bone Cutting Instruments:

    This document is a 510(k) premarket notification for a medical device (Dental Bone Cutting Instruments). A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving independent safety and effectiveness through extensive clinical trials.

    Acceptance Criteria and Reported Device Performance

    The concept of "acceptance criteria" and "device performance" in the context of this 510(k) submission is primarily focused on demonstrating substantial equivalence to a predicate device. The performance data provided is mechanical testing, indicating that the new device performs comparably to the predicate.

    Acceptance Criteria CategorySpecific Criteria (Inferred from testing)Reported Device Performance and Evidence
    Mechanical PerformanceTolerance Analysis (Comparability to predicate)Tolerance Analysis conducted. Performance deemed comparable to that of the primary predicate device.
    Torque and Torsional Testing (Comparability to predicate)Torque and Torsional Testing conducted. Performance deemed comparable to that of the primary predicate device.
    Reliability Analysis (Comparability to predicate)Reliability Analysis conducted. Performance deemed comparable to that of the primary predicate device.
    Safety and EffectivenessNo new questions of safety and effectiveness compared to predicate.Mechanical testing demonstrates any differences in technological characteristics... do not raise any new questions of safety and effectiveness.
    At least as safe and effective as the primary predicate.The proposed devices are at least as safe and effective as the primary predicate.

    Study Details:

    1. Sample Size Used for the Test Set and Data Provenance:

      • Test Set Sample Size: Not specified in the document. The testing performed was "Mechanical Testing" (Tolerance Analysis, Torque and Torsional Testing, Reliability Analysis) which likely involved specific device samples for these tests, but the exact number isn't mentioned.
      • Data Provenance: The testing was conducted by or for Synthes (USA) Products, LLC. The location of the testing laboratories or the origin of the materials used in the testing is not specified. It is an internal company study for regulatory submission.

    2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

      • This type of information is not applicable to this submission. The "ground truth" for mechanical testing is typically established through engineering specifications, material standards (e.g., ASTM F899, ASTM A276), and comparison to the predicate device's known performance, rather than expert consensus on interpretive data like images.

    3. Adjudication Method for the Test Set:

      • Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies where multiple experts interpret data (e.g., medical images) to establish a consensus ground truth. This submission relies on objective mechanical engineering tests.

    4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

      • No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

    5. If a Standalone (algorithm only without human-in-the-loop performance) was done:

      • Not applicable. This device is a manual bone cutting instrument, not an AI algorithm. Therefore, "standalone algorithm" performance is irrelevant.

    6. The Type of Ground Truth Used:

      • For the mechanical testing, the "ground truth" would be the engineering specifications, material properties (e.g., as defined by ASTM standards), and the performance characteristics of the legally marketed primary predicate device (Synthes 90° Screwdriver K082649). The goal was to demonstrate that the subject device's mechanical performance was comparable within acceptable engineering tolerances.

    7. Sample Size for the Training Set:

      • Not applicable. This device is a physical instrument, not a learning algorithm or AI. There is no concept of a "training set" in this context.

    8. How the Ground Truth for the Training Set Was Established:

      • Not applicable for the reason stated above.
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