LogoFDA 510(k) Search
K Number
K982497
Device Name
ARTHROTEK INTERFERENCE SCREW
Manufacturer
BIOMET, INC.
Date Cleared
1998-10-16

(88 days)

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

The Arthrotek Interference Screw is indicated for the following uses:

    1. To provide interference fixation of patellar bone-tendonbone grafts in anterior cruciate ligament (ACL) reconstruction.
    1. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
    1. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.
      Implantation of the Intereference Screw is accomplished through arthroscopy and arthrotomy.
Device Description

The Arthrotek Interference Screw is made of LactoSorb®, which is comprised of bioresorbable, and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in animal and clinical studies in both soft tissue and bone tissue.

AI/ML Overview

The provided text is a 510(k) summary for the Arthrotek Interference Screw, focusing on its substantial equivalence to a predicate device. It describes the device's indications for use and material composition, and mentions "IN VITRO testing demonstrated that the Arthrotek Interference Screw will perform as well as a resorbable predicate device indicated for use in ACL or PCL reconstruction." However, it does not provide details about specific acceptance criteria or a study that rigorously proves the device meets those criteria in a way that allows for a quantitative table or the other requested information regarding sample sizes, expert involvement, or AI performance.

Therefore, many of the requested fields cannot be filled based on the provided document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Acceptance CriteriaReported Device Performance
Specific quantitative criteria for "performance as well as a resorbable predicate device""IN VITRO testing demonstrated that the Arthrotek Interference Screw will perform as well as a resorbable predicate device indicated for use in ACL or PCL reconstruction."
(No specific quantitative metrics or thresholds are provided in the document for comparison.)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • Sample size for test set: Not specified in the document. The statement "IN VITRO testing" does not elaborate on the number of samples tested.
  • Data provenance: Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • Not Applicable. The described testing is "IN VITRO," meaning it was conducted in a laboratory setting. There is no mention of human experts establishing ground truth for the performance testing in this context.

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

  • Not Applicable. No human adjudication method is described for the in vitro performance testing.

5. 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. This document pertains to the regulatory submission of a medical device (interference screw) and does not involve AI or human readers for diagnostic interpretation.

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

  • Not Applicable. This document does not concern an algorithm or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

  • The "ground truth" for the in vitro performance testing would likely be based on engineering measurements and specifications related to the mechanical properties and fixation strength of the device compared to the predicate. The document states it performed "as well as a resorbable predicate device," implying a comparative standard.

8. The sample size for the training set

  • Not Applicable. No training set is mentioned in the context of this device's performance testing, as it is not an AI/ML device.

9. How the ground truth for the training set was established

  • Not Applicable. No training set is mentioned.

§ 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.