Arthrex Compression Screws

• K Number: K170382
• Device Name: Arthrex Compression Screws
• Manufacturer: Arthrex Inc.
• Date Cleared: 2017-05-11 ( 93 days)
• Product Code: HWC
• Regulation Number: 888.3040
• Type: Special
• Panel: OR
• Reference & Predicate Devices: K123241 , K132217

Intended Use

The Arthrex Compression Screws are intended for fixation of fractures, osteotomies and arthrodesis in:

• carpal, metacarpal and small hand bones .
• . tarsal and metatarsals
• . phalanges
• . intra-articular fractures
• . ankle
• . proximal and distal humerus
• . proximal and distal radius
• . proximal and distal ulna
• . osteochondral 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

where size of offered implant is patient appropriate.

Device Description

The Arthrex Compression Screws are a family of titanium, cannulated, compression screws that are offered in a diameter range of 5.0 to 7.0mm, length range of 20 to 140mm, in a fully threaded design.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrex Compression Screws, formatted as requested:

This document is a 510(k) premarket notification for Arthrex Compression Screws. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials with human readers or AI. Therefore, many of the requested fields related to AI performance, human reader studies, and large-scale ground truth establishment are not applicable.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Statistical equivalence to predicate device	Shear, push-out, torque, and compression testing demonstrated statistical equivalence to the predicate.
Meets pyrogen limit specifications	The device meets pyrogen limit specifications.
Substantial equivalence to predicate device	Determined to be substantially equivalent based on indications for use, technological characteristics, and data.

Study Details

1. Sample size used for the test set and the data provenance:

   • The document mentions "Shear, push-out, torque, and compression testing" which are mechanical tests performed on the devices themselves, not tests involving human anatomical samples or patient data.
   • The specific sample sizes for these mechanical tests are not provided in the summary.
   • Data provenance is not applicable as it's not clinical data or images.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The "ground truth" here refers to the performance of the predicate device for comparison in mechanical testing. Expert consensus related to diagnostic imaging or clinical outcomes is not involved.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable, as there's no clinical test set requiring adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was done. This is a medical device (bone fixation screw) and the submission is for its substantial equivalence, not an AI-powered diagnostic or assistive tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithm or AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for comparison was the performance characteristics of the legally marketed predicate device (K132217: Arthrex Compression FT Screws) as measured through mechanical testing. This is a benchmark against a predicate device's established mechanical properties.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning device, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set.

Regulation Number and Section

§ 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.