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K Number
K060714
Device Name
HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
Manufacturer
CONMED LINVATEC
Date Cleared
2006-04-06

(20 days)

Product Code
HWC,MBI
Regulation Number
888.3040
Type
Special
Panel
Orthopedic
Reference & Predicate Devices
K022827
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Conmed Linvatec Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is intended for reattaching soft tissue to glenoid bone in the shoulder. The following are the indications for use: Bankart lessons, SLAP lesions, capsular shifts, capsulolabral reconstructions.

Device Description

The Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is a sterile, single-use, metal implant that is preloaded with high strength size 2 non-absorbable braided polyethylene suture.

The implanted anchor is manufactured from 316LS Stainless Steel, per ASTMF-138, ISO 832-1 and is preloaded with a non-absorbable, braided, ultra-high molecular weight, polyethylene suture.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Hi-Fi UltraFix Knotless Minimite Suture Anchor) and primarily discusses its substantial equivalence to a predicate device, its intended use, and device description.

It does not contain details regarding:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance, or details of a test set.
  • Number or qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance studies.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

Therefore, I cannot fulfill your request with the given information.

§ 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.