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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 11-304
Standard
ASTM F3107-14
Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
Scope/Abstract
1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: Cutting saw (sagittal or reciprocating), Burrs, drills and impact loading. The change in accuracy from detaching and re-attaching, or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured.

1.2 It should be noted that one system may need to undergo multiple iterations (one for each clinical application) of this standard to document its accuracy during different clinical applications since each procedure may have different exposure to outside forces given the surgical procedure variability from one procedure to the next.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Michel D. Janda
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIC/
  301-796-6395
  michel.janda@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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