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K Number
K043281
Device Name
CHARLOTTE HIGH-DEMAND COMPRESSION SCREW
Manufacturer
WRIGHT MEDICAL TECHNOLOGY, INC.
Date Cleared
2005-01-19

(54 days)

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

The CHARLOTTE™ High-Demand Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

  • Fixation of bone fragments, in long bones or small bones fractures
  • Fracture management in the foot or hand
  • Arthrodesis in hand, foot or ankle surgery
  • Mono or Bi-cortical osteotomies in the foot or hand or in long bones
  • Treatment of inferior tibio fibular diastasis
  • Hindfoot arthrodesis
Device Description

The design features of the CHARLOTTE™ High-Demand Compression Screw are summarized below:
Screws

  • Available in 1 diameter, 15 lengths, and 3 thread lengths.
  • Manufactured from Stainless Steel conforming to ASTM F 138, Cold Worked.
  • The distal tip of the screw is to be self drilling.
  • The distal threaded portion is to be self tapping.
  • Packaged non-sterile and sold as a set in a suitable sterilization tray or individually.
    Compression Caps
  • Available in one size.
  • Available with either a grooved or smooth outer surface.
  • Manufactured from Stainless Steel conforming to ASTM F 138, Cold Worked.
AI/ML Overview

The provided text is a 510(k) summary for the CHARLOTTE™ High-Demand Compression Screw. It discusses the device's intended use, description, and substantial equivalence to a previously cleared predicate device.

However, this document does not contain information about acceptance criteria or performance studies in the context of AI/ML or diagnostic devices. It describes a physical medical device (a bone fixation screw) and its clearance process based on substantial equivalence to an existing product, rather than performance metrics from a clinical study or an algorithm's performance.

Therefore, I cannot provide a response filling in the requested table and information points as they are not applicable to the content of this document. This document does not describe:

  • Acceptance criteria for an AI/ML device.
  • "Reported device performance" in terms of sensitivity, specificity, or similar metrics.
  • Sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, or how ground truth was established for training sets.

The "study" mentioned is "testing conforming to ASTM 543-02" which refers to a standard for material and mechanical properties of the screw, not a clinical or AI performance study. The substantial equivalence is based on design features, material, and indications for use being similar to the predicate device, confirmed by adherence to this ASTM standard.

§ 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.