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K Number
K981688
Device Name
ANSPACH SUTURE ANCHOR
Manufacturer
THE ANSPACH EFFORT, INC.
Date Cleared
1998-07-13

(63 days)

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

Fixation of soft tissue to bone in applications including the pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella and bones of the hand and foot. Specifically not intended for use in the spine or for repair of the anterior or posterior cruciate ligaments.

Device Description

Anspach Suture Anchor

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "Anspach Suture Anchor." This document primarily deals with regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results of the device itself.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth types associated with a specific performance study cannot be extracted from this document.

The document does not contain information about:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets or their data provenance.
  • Number of experts used to establish ground truth or their qualifications.
  • Adjudication methods.
  • MRMC comparative effectiveness studies or effect sizes.
  • Standalone performance studies.
  • The type of ground truth used (e.g., pathology, outcomes data).
  • The sample size for the training set.
  • How the ground truth for the training set was established.

The document is a regulatory letter confirming substantial equivalence to a predicate device based on general controls and manufacturing practices, not a clinical study report or performance validation document.

§ 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.