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K Number
K963618

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Device Name
SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
Manufacturer
SYNTHES (USA)
Date Cleared
1996-11-12

(63 days)

Product Code
LXT
Regulation Number
888.3030
Type
Traditional
Panel
Orthopedic
Age Range
All
Reference & Predicate Devices
N/A
Predicate For
K012623,K141760,K984498,K993649
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Synthes SSEF stabilizes fractures of the distal radius. The components that make up a SSEF frame include the Schanz screws, adjustable clamps, rods, and end caps.

Device Description

The components that make up a SSEF frame include the Schanz screws, adjustable clamps, rods, and end caps. The adjustable clamps of the SSEF are manufactured from a titanium alloy and stainless steel. The rods of the SSEF are manufactured from carbon fiber reinforced epoxy and the end caps of the SSEF are manufactured from polyvinyl chloride.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device called the "Synthes SSEF" and compares it to another device, the "EBI's Orthofix Penning Dynamic Wrist Fixator," based on mechanical testing.

However, it does not discuss:

  • Acceptance criteria or reported device performance in the context of a study involving AI or diagnostic accuracy. The "performance" mentioned refers to mechanical performance, not diagnostic.
  • Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods. These are typical elements of studies evaluating AI or diagnostic tools, which is not the subject of this document.
  • MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot populate the table or provide the detailed information requested based on this text.

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NOV 1 2 1996

Summary of Safety and Effectiveness Information Attachment IX:

K963618

Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301

(610) 647 - 9700 Contact: Angela J. Silvestri September 1996

Synthes SSEF is compared to the EBI's Orthofix Penning Dynamic Wrist Fixator.

The Synthes SSEF stabilizes fractures of the distal radius. The components that make up a SSEF frame include the Schanz screws, adjustable clamps, rods, and end caps. It is anticipated that the most common use of the device would be as follows:

    1. A small incision is made over the second metacarpal and radius.
    1. Using the Parallel Drill Guide for soft tissue protection and positioning, a pair of Self-Drilling Schanz Screws are inserted into the second metacarpal and radius.
    1. An adjustable clamp is slid over each pair of Schañz Screws and tightened to lock on the pins.
    1. An appropriately sized rod is slid through each clamp.
    1. End caps are applied to each end of the rod to captivate the clamps.
    1. The fracture is reduced.
    1. The remaining screws on both adjustable clamps are tightened to hold the reduction.

The adjustable clamps of the SSEF are manufactured from a titanium alloy and stainless steel. The rods of the SSEF are manufactured from carbon fiber reinforced epoxy and the end caps of the SSEF are manufactured from polyvinyl chloride.

The EBI's Orthofix Penning Dynamic Wrist Fixator also stabilizes fractures of the distal radius. It is manufactured from stainless steel and anodized aluminum.

Based on the results of the mechanical testing, Synthes SSEF is at least equivalent to the EBI's Orthofix Pennig Dynamic Wrist Fixator in performance.

N/A