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510(k) Data Aggregation

    K Number
    K201850
    Device Name
    Vector Hammertoe Correction System
    Manufacturer
    Nvision Biomedical Technologies, Inc
    Date Cleared
    2020-08-04

    (29 days)

    Product Code
    HWC,CLA
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K183055,K161449,K133636
    Predicate For
    K213421
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

    Device Description

    The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.0mm (cannulated), Ø3.50mm (cannulated and non-cannulated) and Ø4.00mm (cannulated and non-cannulated) and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

    AI/ML Overview

    The provided text is a 510(k) summary for the VECTOR™ Hammertoe Correction System. It describes the device, its indications for use, and its equivalence to predicate devices, primarily through engineering analysis. This document does not contain information about an AI/ML powered device, nor does it present acceptance criteria or a study proving device performance in the context of AI/ML.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and data provenance
    3. Number of experts used to establish ground truth and their qualifications
    4. Adjudication method
    5. MRMC comparative effectiveness study results
    6. Standalone (algorithm only) performance data
    7. Type of ground truth used
    8. Sample size for the training set
    9. How ground truth for the training set was established

    The document explicitly states: "No FDA performance standards have been established for the Vector Hammertoe Correction System. The following was performed to demonstrate safety per methods of the previous submission: Engineering Analysis comparison of mechanical performance characteristics." This indicates that the safety and effectiveness were demonstrated through mechanical performance characteristics engineering analysis and comparison to predicates, not through clinical or AI/ML performance studies with human readers or AI algorithms.

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