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    K Number
    K201336
    Device Name
    DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
    Manufacturer
    Synthes (USA) Products, LLC
    Date Cleared
    2020-09-03

    (106 days)

    Product Code
    JDS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm

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

    DePuy Synthes Tibial Nail Advanced System:

    The Tibial Nail Advanced implants are intended for treatment of fractures in adolescents (12-21) in which the growth plates have fused. Specifically, the implants are indicated for:

    • · Open and closed proximal and distal tibial fractures
    • Open and closed tibial shaft fractures
    • · Tibial malunions and nonunions

    DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm:

    DePuy Synthes Locking Screws are used for the static and dynamic interlocking of femoral, humeral and tibial nails.

    Device Description

    DePuy Synthes Tibial Nail Advanced System:
    The DePuy Synthes Tibial Nail Advanced System is a system comprised of intramedullary nails, locking screws, end caps implants, as well as system-specific insertion instruments. The Tibial Nail Advanced System is intended to be used for temporary fixation and stabilization of tibia. This system enables three different surgical approaches for the insertion of the nailing implant in the tibia: suprapatellar. parapatellar, and infrapatellar. The implants are manufactured from titanium alloys and provided in a range of dimensions to match individual patient anatomy. The intramedullary nailing implants are cannulated and can be inserted over a reaming rod. The nailing implants are offered in a range of proximal and distal shaft diameters and lengths to accommodate patient anatomy and surgical need related to the specific fracture patterns and locations. The nails will be manufactured from titanium alloy (Ti-6Al-4V) and polyetherketone (PEEK).

    DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm:

    The DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm have a diameter of 5 mm available in lengths ranging from 26 up to 120 mm and a diameter of 4 mm available in lengths ranging from 18 up to 80 mm. These implantable devices are fully threaded at the shaft and are self-tapping. The locking screws feature either a standard screw head or a low-profile screw head. The screws are made from titanium alloy (Ti-6Al-7Nb).

    AI/ML Overview

    This appears to be a 510(k) summary for a medical device (DePuy Synthes Tibial Nail Advanced System and Locking Screws). These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies with specific acceptance criteria, sample sizes, and expert adjudication for AI/software performance.

    Therefore, the requested information regarding AI/software performance studies, acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies is not present in the provided document.

    This document describes a traditional medical device (implants and screws for bone fixation) and its non-clinical performance data (mechanical testing, biocompatibility, MRI safety), comparing it to predicate devices. There is no mention of any AI or software component in this device.

    Table of Acceptance Criteria and Reported Device Performance:

    Since this document describes a physical medical device (implants and screws) and not an AI/software device, the acceptance criteria and performance are based on non-clinical tests comparing it to predicate devices. The document states that the new device is "substantially equivalent" to predicate devices, meaning it performs at least as safely and effectively.

    Acceptance Criteria CategorySpecific Test/EvaluationReported Device Performance
    BiocompatibilityLAL testing per FDA guidance "Submission and Review of Sterility Information..."Meets 20 EU/device limit when sterilized by gamma radiation.
    Biocompatibility assessment per FDA guidance "Use of International Standard ISO 10993-1..."Assessment supports safety according to the standard.
    Mechanical Strength (Tibial Nail System)Proximal and distal locking static torsion test (according to ASTM F1264-16 A2.1.7).Performance supports substantial equivalence to predicate device (Synthes (USA) Tibial Nail System Ex K040762).
    Static 4-point bending test of the nail shaft (according to ASTM F1264-16 A1).Performance supports substantial equivalence to predicate device.
    Torsion testing of the nail shaft (according to ASTM F1264-16 A2).Performance supports substantial equivalence to predicate device.
    Dynamic 4-point bending test of the nail shaft (according to ASTM F1264-16 A3).Performance supports substantial equivalence to predicate device.
    Mechanical Strength (Locking Screws)Engineering analysis on static and cyclic 3-point bending of the locking screws (according to ASTM F1264-16 A4).Performance supports substantial equivalence to predicate device (Synthes 4.0 and 5.0mm Locking Screws K000089).
    Torsional properties of the locking screws (according to ASTM F543-17 A1).Performance supports substantial equivalence to predicate device.
    Driving torque of the locking screws (according to ASTM F543-17 A2).Performance supports substantial equivalence to predicate device.
    Driving torque and axial push-out strength of the locking screws (according to ASTM F543-17 A2 and A3).Performance supports substantial equivalence to predicate device.
    Self-tapping performance of the locking screws (according to ASTM F543-17 A4).Performance supports substantial equivalence to predicate device.
    MRI SafetyMRI testing in accordance with standards ASTM F2052-14, ASTM F2213-06, ASTM F2182-11a, and ASTM F2119-07.Performance supports safety and substantial equivalence in an MRI environment.
    Overall ConclusionComparison of technological characteristics, intended use, indications for use, design features, materials, and operating principle to predicate devices. Any differences do not raise new questions of safety and effectiveness; devices are at least as safe and effective.Substantially Equivalent to predicate devices. ("The proposed devices are at least as safe and effective as the predicate devices.")

    Regarding AI/Software specific questions:

    1. Sample size used for the test set and the data provenance: Not applicable. This document does not describe an AI/software device or a test set of data.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI/software test set is mentioned.
    3. Adjudication method for the test set: Not applicable. No adjudication for an AI/software test set is mentioned.
    4. 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. No AI component is described.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI component is described.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for these devices would be established by physical measurements and engineering standards.
    7. The sample size for the training set: Not applicable. No AI component is described.
    8. How the ground truth for the training set was established: Not applicable. No AI component is described.
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