Verification and Validation Test Plan Rev 2.0

Three-Segment TLSO Brace

Team Members:

Dave Hower

Jessica Schaberl

Anjani Ravindra

Kimberly Zawrotny

Revision Log:

Date / Rev / Changes Made / Signed
2/12/07 / 1.0 / Initial Document
4/16/07 / 2.0 / Results and Conclusions Added

Purpose:

The purpose of this document is to verify whether or not the proposed Three-Segment TLSO brace increases the ease of correct TLSO brace placement, and decreases the time required for correct TLSO brace placement. Please note that this document was prepared for the purposes of the BioE 1161 Senior Design course, and a full validation and verification test plan would be required for final FDA submission.

Standards Utilized:

Product Design Specifications Rev 1.2, Sections 1 and 7.

Methods:

Timed trials will be conducted utilizing Hanger Orthotics’ facilities. A Hanger employee,experienced in putting on TLSO braces,will be timed while placing the traditional bi-valve brace on a test subject. Then, the process will be repeated with the Three-Segment brace. Each brace will be placed three times, and the average time of the trials will be compared to determine whether or not an improvement in speed was seen with the Three-Segment brace.

A second time test will compare the time it takes to put the bi-valve brace on oneself versus the three-segment brace. The subject will attempt to place the bi-valve TLSO brace while in the proper supine position. The test will be repeated using the Three-Segment TLSO brace. Each brace design will be placed three times, and the average time of the three trials will be compared between the two brace designs.

A third test will quantify the amount of rolling required to properly position the Three-Segment TLSO brace, as compared to the bi-valve brace. During the self-placement time trial described above, the number of times the subject needs to log roll in order to position the brace will be recorded for each test of each brace. A full log roll will be considered a motion that brings the subject entirely onto one side. A half log roll will be considered a motion that only involves partial shifting of weight onto one side. The average number of log rolls required to put on each brace across the three trials will be compared.

Validation:

Validation will be achieved by receiving approval of the design from both Orthotics and Rehabilitation specialists.

Results:

  • The average time required for the Hanger employee to place the bi-valve brace was 89.3 seconds. The average time required for him to place the Three-Segment brace was 45seconds. The average time for placement of the bi-valve brace was 117seconds, with 2.8 log rolls required. The average time for placement of the Three-Segment brace was 99seconds, with 1.5 log rolls required.
  • Both Orthotics and Rehabilitations specialists approved the design of the Three-Segment TLSO brace.

Conclusions:

The results indicate that the Three-Segment TLSO brace is faster to place than the bi-valve brace. This holds true for both assisted and self-placement of the brace. Faster placement times indicate an easier placement procedure.

Signatures:

______

Dave HowerDate

______

Jessica SchaberlDate

______

Anjani RavindraDate

______

Kimberly ZawrotnyDate

Appendix:

Time Trial 1: Orthotics Specialist
Brace Type / Trial / Time (sec)
Bi-Valve / 1 / 83
2 / 105
3 / 80
Three-Segment / 1 / 40
2 / 45
3 / 50
Time Trial 2: Individual
Brace Type / Trial / Time (sec)
Bi-Valve / 1 / 130
2 / 111
3 / 109
Three-Segment / 1 / 103
2 / 99
3 / 95
Rolling Trial
Brace Type / Trial / Rolls Required
Bi-Valve / 1 / 3.5
2 / 2.5
3 / 2.5
Three-Segment / 1 / 1.5
2 / 1.5
3 / 1.5

Verification and Validation Test Plan Rev 2.0

4/16/07