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K Number
K955837

Validate with FDA (Live)

Device Name
CANNULATED PLUS HIP SCREW (STERILE)
Manufacturer
WRIGHT MEDICAL TECHNOLOGY, INC.
Date Cleared
1996-03-04

(69 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
Orthopedic
Age Range
All
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Cannulated PLUS™ Hip Screw (Sterile) is intended to be used in the fixation of cancellous bone, for treatment of conditions such as, but not limited to:

  • femoral neck fractures: 1.
    1. arthrodesis of the hip;
    1. femoral condvie fractures:
    1. tibial plateau fractures;
    1. ankle malleolar fractures; or
    1. elbow fractures
Device Description

The Cannulated PLUS™ Hip Screw (Sterile) is a cannulated bone screw. An optional beveled washer is available for use with osteoporotic bone. The device is available in a range of sizes to fit varying anatomical requirements.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device: the Cannulated PLUS™ Hip Screw (Sterile). This document focuses on regulatory submission for a physical medical implant, not a software or AI-driven diagnostic device. Therefore, the specific information requested about acceptance criteria, study design, and ground truth, which are typically relevant for evaluating the performance of diagnostic algorithms, are not present in this type of document.

Here's why the requested information cannot be extracted from the provided text:

  • Acceptance Criteria for Device Performance: For a physical implant like a hip screw, "acceptance criteria" would primarily relate to mechanical properties (e.g., tensile strength, fatigue life), biocompatibility, and manufacturing tolerances. These are typically established through engineering standards and testing, not in terms of diagnostic metrics like sensitivity, specificity, or AUC as for an AI model. The document indicates it's a 510(k) submission, meaning it aims to show substantial equivalence to a predicate device, rather than proving performance against new, specific clinical outcome criteria in a large-scale study for new functional performance.
  • Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth): These items pertain to the evaluation of a diagnostic or AI algorithm's ability to interpret data and provide an output. A hip screw is a therapeutic device. Its performance is demonstrated through biomechanical testing, material analysis, and potentially clinical follow-up for safety and efficacy in human subjects (though not typically detailed in a 510(k) summary in this manner). The 510(k) process relies on demonstrating equivalence to devices already on the market, not necessarily extensive new clinical effectiveness studies with the parameters you've listed.

In summary, the provided K95583 document does not describe the kind of acceptance criteria or study design that would involve AI performance metrics, ground truth establishment, or expert adjudication as typically requested for evaluating AI/diagnostic devices.

Therefore, I cannot populate the table or answer the specific questions about AI/diagnostic study design based on this physical device's 510(k) summary.

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K95583ๆ

Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo consists of a stylized "W" symbol on the left, followed by the word "WRIGHT" in large, bold letters. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller font. The address "5677 AIR LINE ROAD ARLINGTON, TN 38002" and the number "901 937 9971" are printed below the company name.

510(k) SUMMARY

Contact Person: Judy English Date Prepared: December 22, 1995

Trade Name:Cannulated PLUS™ Hip Screw (Sterile)
Common Name:Hip Bone Screw
Classification:II
Predicate Device:Cannulated PLUS™ Hip Screw

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Description/Intended Use

The Cannulated PLUS™ Hip Screw (Sterile) is a cannulated bone screw. An optional beveled washer is available for use with osteoporotic bone. The device is available in a range of sizes to fit varying anatomical requirements.

The Cannulated PLUS™ Hip Screw (Sterile) is intended to be used in the fixation of cancellous bone, for treatment of conditions such as, but not limited to:

  • femoral neck fractures: 1.
    1. arthrodesis of the hip;
    1. femoral condvie fractures:
    1. tibial plateau fractures;
    1. ankle malleolar fractures; or
    1. elbow fractures

Material

The Cannulated PLUS™ Hip Screw (Sterile) is manufactured from stainless steel. The optional washer is also manufactured from stainless steel.

N/A