LogoFDA 510(k) Search
K Number
K133713
Device Name
CHARLOTTE (TM) SNAP-OFF SCREW
Manufacturer
WRIGHT MEDICAL TECHNOLOGY, INC.
Date Cleared
2014-03-07

(92 days)

Product Code
HWC
Regulation Number
888.3040
Type
Special
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

  • Fixation of Small Bone Fragments
  • Weil osteotomy
  • Mono-cortical fixation
  • Osteotomies and fractures fixation in the foot and hand
Device Description

The CHARLOTTE™ Snap-Off screw is a cortical bone screw intended to aid in achieving fixation of bone fragments or bone reconstruction.
The design features and function of the CHARLOTTE™ Snap-Off Screw are substantially equivalent to the design features previously cleared under the CHARLOTTE™ Snap-Off screw and are highlighted below:

  • Manufactured from ASTM F136 (Ti-6AI-4V ELI) .
  • . Self-drilling and self-tapping features on distal threads
  • Groove in head of screw around neck connection to drive mechanism to allow for snap off of ● drive mechanism shaft below screw head surface
    The subject screws in this Special 510(k) include a change in the tip geometry of the snap-off 2,0mm diameter screw as well as the introduction of additional screw lengths to the 2.0mm and 2.7mm diameter screws to fill in sizes not previously included. Additionally, screws that are provided sterile have been added.
AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device (CHARLOTTE™ Snap-Off Screw), not a study analyzing AI performance or diagnostic accuracy. Therefore, it does not contain the information required to answer your request regarding acceptance criteria, study design, expert involvement, or AI performance metrics.

The document discusses the substantial equivalence of an updated screw design to its predicate devices based on mechanical testing, but it does not involve any diagnostic algorithms, image analysis, or human reader performance.

To summarize, based on the provided text, I cannot extract the following information:

  1. Table of acceptance criteria and reported device performance: This document is about a physical medical device (a screw), not a diagnostic algorithm. The "performance" discussed relates to mechanical properties, not diagnostic accuracy.
  2. Sample size used for the test set and data provenance: Not applicable to this type of device submission.
  3. Number of experts used and their qualifications: Not applicable.
  4. Adjudication method: Not applicable.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
  6. Standalone (algorithm only) performance: Not applicable.
  7. Type of ground truth used: Not applicable.
  8. Sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.