Recurring Meeting of Cleveland Clinic Core Team

Date: September 30, 2014

Time: 10:30 AM EST

Means: In person meeting

Attendees:

1. Ahmet Erdemir
2. Craig Bennetts
3. Snehal Chokhandre
4. Robb Colbrunn
5. Tara Bonner
6. Sam Doerle

Agenda:

1. Discuss immediate action items from the last meeting.
2. Discuss testing schedule and preparation for oks specimen to be tested in October.
3. Decide immediate action items for the next meeting.
4. Other.

Immediate Action Items:

• Snehal
  • Finalize ligament testing specifications and replicate the documentation for other tissue types.
  • Correct tissue sample labeling of oks004 to conform to data management specifications.
  • Complete tissue testing of oks004.
• Robb
  • Ask Ryan and Tony (of Medical Device Solutions) about tapping of the 3D printing material.
• Ahmet
  • Follow-up with Ryan (of Medical Device Solutions) to get a quote on 3D printing of new registration marker design.
  • Ask Jason Halloran to sit in for the patellofemoral joint testing.
  • Schedule Advisory Board meeting for late October/early November.
• All
  • Read, evaluate, and if necessary update specifications (which you lead) for oks001 testing.

Notes:

1. Discuss immediate action items from the last meeting.
   • Snehal updated the tissue specifications page reflecting Ahmet's comments. She will finalize the ligament testing documentation and replicate it for other tissue types.

   • Ahmet prepared CAD representation of the new registration marker design using Salome v7.2. The design file and Python script to change design parameters are available in the utilities folder of the source code repository. Robb will contact Ryan & Tony (from Medical Device Solutions of the Cleveland Clinic) about tapping of the 3D printing material. Ahmet will finalize the design and get a quote estimate for development of new registration markers.

   • Craig followed up with Shannon (from the imaging facility of the University Hospitals). It seems like the noise in the general purpose imaging of oks004 is related to the issues faced during that day. Craig still needs to update imaging specifications to incorporate evaluation of images as they are collected.
   • Robb and Tara evaluated the tibiofemoral joint loading profiles of oks004 and decided to double the wait time to let the robot settle to the desired loading state. This will be done for both laxity testing and for combined loading scenarios. This will increase testing of each condition from 6 minutes to 12 minutes. The trials will likely take 2.5 hours. Four hours may need to be allocated to accommodate robot initialization and preparation time between trials.
   • Robb and Tara also evaluated the setup of quadriceps line of action for patellofemoral joint testing. This will be adjusted to prevent potential loss of Optotrak markers placed on the tibia.
   • Ahmet, Craig and Snehal discussed data extraction script for tissue testing data acquired by the Mach-1 system. Snehal will start updating the script in her down time to reflect this discussion. Similar scripts will eventually be needed to extract joint testing data.
2. Discuss testing schedule and preparation for oks specimen to be tested in October.
   • The team discussed the order of events for next week's testing. If possible, the imaging schedule will be rearranged for an earlier time. This will provide more time for tibiofemoral joint testing. Snehal will ask Shannon (from the imaging facility) if there is a time before 10:00 AM.
   • The leads for individual components of testing were identified:
     • Snehal (with Ahmet): of specimen thawing (Sunday).
     • Tara (with Craig, Snehal): specimen preparation (Monday).
     • Craig (with Snehal): specimen imaging (Tuesday morning).
     • Robb (with Ahmet): pressure sensor equilibration and calibration for patellofemoral joint measurements (Monday morning).
     • Tara (with Robb, Snehal, Craig): tibiofemoral joint testing (Tuesday afternoon).
     • Robb (with Ahmet, Tara): patellofemoral joint testing (Wednesday morning).
     • Snehal (with Craig, resident): tissue dissection (Wednesday afternoon).
   • Each team members should review their corresponding specifications.
   • Ahmet will follow all the procedures to check if protocols conform to specifications.
3. Decide immediate action items for the next meeting.
   • Action items were discussed and agreed upon. See Immediate Action Items above.
4. Other.
   • Ahmet noted tissue sample labeling issues for oks004. Snehal will correct tissue sample and data labeling to conform to specifications.
   • Snehal will test the rest of oks004 tissue samples this week. Ahmet will help.