1. Avoiding Pitfalls: Testing Considerations

2. How Do I Test It? Which tests? Which specifications? What size?
ASTM, ISO, Custom Protocols
What size?
How many?
What targets? Minimum Acceptance Criteria?
What predicate devices?

3. How do I test it? Guidance Documents
FDA Guidance Documents:
Guidance for Industry and FDA Staff: Spinal System 510(k)s
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
Information about Indications, Mechanical Testing, Wear Testing, Animal and Clinical studies, Sterilization, Worst Case Scenarios, etc.

4. How do I test it? Guidance Documents
System Type
Product Code
Recommended Testing
Recommended Additional Information
Anterior, Cervical
System
KWQ
Static and dynamic axial compression bending testing
Static torsion testing
A statement clarifying whether the system is intended for unilateral and/or bilateral fixation
A comparison of the worst case construct’s width and prominence to a predicate system 

5. How do I test it? Guidance Documents
System Type
Product Code
Recommended Testing
Recommended Additional Information
Vertebral Body
Replacement
Device/System
(VBR)
MQP
Static and dynamic axial
compression bending testing
· Static and dynamic torsion testing
· Expulsion
For the dynamic axial compression
bending tests, we recommend that you
meet one of the following conditions:
Depending on the design of
the VBR system, we may
recommend additional testing
(e.g., shear loading of a
composite material, off-axis
compression loading)
· A clinical rationale for all sizes
of the proposed VBR

6. ASTM Specifications
Test methods intended to provide a basis for the mechanical comparison among past, present, and future implant assemblies.
Scope
Reference Documents
Terminology
Summary of Test Method
Significance and Use
Apparatus
Sampling
Procedure (Starting place for protocol development)
Report
Precision and Bias (Repeatability)

7. Know your target - Predicate Device & Worst Case Evaluation
Know what predicate values you are targeting ahead of time
Perform testing (feasibility if necessary)
Identify and Evaluate Worst Case Scenario
Finite Element Analysis (FEA) – Allows for quick evaluation of stresses in various loading conditions

8. Static Testing How much force will it take to break it?
Ultimate force
Yield force
Stiffness
Failure Mode
Differentiates between elastic and plastic deformation regions
Determines starting points for fatigue curve

9. Dynamic Testing (Fatigue)
What is the highest load that will survive a particular cycle count?
Load versus cycle count endurance curve

10. Testing - Common Spine Specifications
Pedicle screw, rod, and hook systems
ASTM F1798
ASTM F1717
ASTM F2706
ASTM F2193
Spacers and cages
ASTM F2077
ASTM F2267
Screws
ASTM F543

11. ASTM F1798 Spinal Implant Connection Testing Flexion/Extension
Axial Slip
Torsional Grip
Transverse Moment

12. ASTM F1717 Spinal Implant Constructs in Vertebrectomy Model
Static Compression
Dynamic Compression
Static Tension
Static Torsion

13. ASTM F1717 Failure Modes Common Failures Screws Rods Laser Markings
create stress risers
Alpha Case

14. ASTM F2077 Intervertebral Body Fusion Devices
Static & Dynamic Compression
Static & Dynamic Compression Shear
Static & Dynamic Torsion
Subsidence (ASTM F2267)
Expulsion

15. ASTM F2077- Failure Modes Static Failure Mode – Plastic Deformation
Dynamic Failure Mode - Fatigue Cracks

16. Wear Testing Articulating Surfaces, Mixed Material Devices
In vitro Testing – Wear
Mass Loss Analysis
SEM particulate evaluation
Multi-Axis Wear Testing
ISO :2011

17. Resources Available Pre-510(k) meeting with the FDA
Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff
Regulatory and Consulting Agencies
Highly recommended if performing submissions for the first time
Help determine worst case scenario, testing needs, and put together 510(k) submissions
Consult your testing laboratory
Familiar with Specifications (Participate in ASTM)
Test similar devices, see newest technologies and methods
Provide recommendations based on experience
Develop fixturing and protocols