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K Number
K182361
Device Name
Arthrex Compression FT Screws
Manufacturer
Arthrex Inc.
Date Cleared
2018-12-18

(110 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K132217,K141735
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Arthrex Compression FT Screws are intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:

  • . Osteochondral fragments (talar vault, femoral condyle)
  • . apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)
  • . cancellous fragments (talus)
  • o Carpal, metacarpal, and small hand bone
  • . tarsal and metatarsals
  • . phalanges
  • . Intra-articular fractures
  • o ankle
  • . proximal and distal humerus
  • . proximal and distal radius
  • . proximal and distal ulna
  • . osteocondral fixation and fractures
  • Osteochondritis Dissecans .
  • . Fixation of fractures and osteotomies about the knee
  • Oblique fractures of the fibula .
  • . Reconstructive surgeries of the foot
  • . malleolar fixation
Device Description

The Arthrex Compression FT Screws are a family of titanium, cannulated, compression screws that are offered in a diameter range of 2.5 to 4.0mm, length range of 32 to 60mm, in a fully threaded design.

AI/ML Overview

The provided text is a 510(k) summary for the Arthrex Compression FT Screws. It describes the device, its intended use, and its equivalence to predicate devices, but does not contain information related to the acceptance criteria of a study, the study itself, or its results in the context of device performance metrics often associated with AI/ML devices.

The document states that "Push-out, torque and compression testing were conducted to demonstrate that the proposed longer Arthrex Compression FT Screws perform statistically equivalent to the predicate." However, it does not provide:

  • A table of acceptance criteria and the reported device performance.
  • Sample size used for the test set and data provenance.
  • Number of experts used to establish ground truth or their qualifications.
  • Adjudication method.
  • Multi-reader multi-case (MRMC) comparative effectiveness study data or effect size.
  • Standalone algorithm performance data.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

This type of information is typically found in submissions for devices that incorporate AI/Machine Learning, which this traditional orthopedic fixation device does not. The 510(k) for the Arthrex Compression FT Screws focuses on demonstrating substantial equivalence through engineering and biomechanical testing against predicate devices.

§ 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.