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510(k) Data Aggregation

    K Number
    K213108
    Device Name
    Humerus & Ulna System
    Manufacturer
    Auxein Medical Private Limited
    Date Cleared
    2022-11-04

    (406 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K033995,K141680,K082072,K082625,K082807
    Why did this record match?
    Reference Devices :

    K033995, K141680, K082072

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

    Specific Indications:

    1. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate
      2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate is intended for treating of Intraarticular Fracture of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus.
    2. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support
      2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support is intended for treating of Intraarticular fractures of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus.
    3. 2.7/3.5mm Wise-Lock Dorsolateral Medial Distal Humerus Plate
      2.7/3.5mm Wise-Lock Dorsolateral Medial Distal Humerus Plate are indicated for treating of Intraarticular fractures of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus.
    4. 3.5mm Wise-Lock Extra-Articular Distal Humerus Plate
      3.5mm Wise-Lock Extra-Articular Distal Humerus Plate are indicated for fractures of the distal humerus.
    5. PHEELOS-3.5mm Wise-Lock Proximal Humerus Plate, Short
      PHEELOS Short Indications
    • · Dislocated two-, three-, and four-fragment fractures of the proximal humerus
    • · Pseudarthroses in the proximal humerus
    • · Osteotomies in the proximal humerus
    1. PHEELOS-3.5mm Wise-Lock Proximal Humerus Plate, Long
      • As for PHEELOS Short, but for fractures extending to the shaft or without medial support.
    2. 3.5mm Wise-Lock Proximal Humerus Plate
      The 3.5mm Wise-Lock Proximal Humerus Plate is intended for fractures and fracture dislocations, and nonunions of the proximal humerus.
    3. 3.5mm Wise-Lock Periarticular Proximal Humerus Plate
      3.5mm Wise-Lock Periarticular Proximal Humerus Plate are indicated for fracture dislocations, osteotomies, and nonunions of the proximal humerus.
    4. 3.5mm Wise-Lock Olecranon Plate
      3.5mm Wise-Lock Olecranon Plate is indicated for fixation of fractures and non-unions of the olecranon.
    5. 3.5mm Wise-Lock Hook Plate
      3.5mm Wise-Lock Hook Plate is indicated for fractures, osteotomies of small bones including the ulna, radius, tibia and fibula.
    6. 2.7mm Wise-Lock Screw, Self-Tapping (Hex Head)
      This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
    7. 3.5mm Wise-Lock Screw, Self-Tapping (Hex Head)
      This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
    8. 3.5mm Wise-Lock Screw, Self-Drilling, (Hex Head)
      This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
    9. 3.5mm Wise-Lock Cancellous Screw, Full Thread, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
    10. 3.5mm Wise-Lock Cancellous Screw, Short Thread, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
    11. 3.5mm Cortical Screw, Self-Tapping, (Hex Head)
      This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
    12. 4.0mm Cancellous Screw, Short Thread
      This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
    13. 4.0mm Cancellous Screw, Full Thread
      This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
    14. 2.7mm Cortical Screw, Self-Tapping, (Hex Head)
      This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.
    Device Description

    The Humerus and Ulna System consists of various types of bone plates, Screws for implantation in the humerus and ulna bone to treat humerus and ulna bone fractures.
    The Humerus and Ulna System consists of medial and postero-lateral distal humerus plates of various lengths and 2.7 mm locking screws. The plates are pre-contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate features locking compression holes which accept 2.4, 3.5, & 4.0 mm cortex screws, 2.4, 2.7 & 3.5 mm locking screws, and 4.0 mm cancellous screws. The System is available in Stainless Steel and Titanium.
    These implants are sold in both non-sterile and sterile conditions.
    Note- Non sterile products have to be sterilized before use.
    The system is indicated for use in adult patients only. All implants are for single use only.
    The humerus and Ulna System contains several plates and each plate has its intended uses.

    AI/ML Overview

    The provided 510(k) summary describes a medical device, the "Humerus & Ulna System" by Auxein Medical Private Limited, which consists of various bone plates and screws for humerus and ulna bone fracture fixation. The document states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain information related to software or AI/ML components. Therefore, it is impossible to extract the acceptance criteria for an algorithm, the details of a study proving a device meets those criteria, or other AI/ML-specific information like sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

    The document primarily focuses on demonstrating substantial equivalence through:

    • Comparison of technological characteristics: Product code, regulation number, regulatory class, indications for use, material, performance standards, sterilization, shelf-life, single use/reuse, operating principle, and dimensional verification are compared to predicate devices.
    • Non-clinical (bench) testing: This includes material standards (ASTM F136/ISO 5832-3, ASTM F899-12, ASTM F138/ISO 5832-1), biocompatibility (ISO 10993), and mechanical performance (ASTM F382 for plates, ASTM F543 for screws, including driving torque, torsion, and axial pull-out tests).
    • Sterilization, shelf-life, and packaging standards: (ISO 11137 series, ISO 17665 series, ISO 11140-1, ISO 11737 series, ISO 11607 series, ASTM F1980, ASTM F88, ASTM F1929).
    • Bacterial Endotoxin testing: (USP , USP ).

    All of these tests are standard for orthopedic implants and confirm the physical and biological safety and performance of the hardware, but they do not involve any AI/ML algorithm evaluation.

    Therefore, based solely on the provided text, I cannot answer the specific questions related to acceptance criteria and studies for an AI/ML component. The device described is a physical implant system, not a software-driven diagnostic or treatment planning tool that would typically involve the type of AI/ML evaluation metrics requested.

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