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K Number
K954683
Device Name
QUESTLOCK ACL FIXATOR
Manufacturer
WRIGHT MEDICAL TECHNOLOGY, INC.
Date Cleared
1996-04-23

(195 days)

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

The QuestLock ACL Fixator is intended to provide a means for firmly securing a bone-Patellar Tendon-bone graft during reconstruction of an Anterior Cruciate Ligament (ACL).

Device Description

The QuestLock ACL Fixator is made from Titanium alloy.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "QuestLock ACL Fixator." It provides information about the device's intended use and substantial equivalence, but it does not contain the detailed study information or acceptance criteria requested in your prompt.

Specifically, the document states:

  • "The QuestLock ACL Fixator demonstrates acceptable pull out strengths."

However, it does not provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number of experts used to establish ground truth or their qualifications.
  4. Adjudication method.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
  6. Details about a standalone algorithm performance study. (This is a physical device, not an algorithm).
  7. The type of ground truth used. (It mentions "pull out strengths," which implies quantitative mechanical testing, but no specific ground truth definition is given).
  8. Sample size for the training set. (Not applicable for this type of device testing).
  9. How the ground truth for the training set was established. (Not applicable for this type of device testing).

To answer your prompt fully, you would need access to the full 510(k) submission or the detailed testing report referenced in this summary.

§ 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.