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Test ID CodeProtocol TitleUser NeedsDesign RequirementsAcceptance CriteriaResultsNotes
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VAL.01Cost AnalysisAffordability4.1 Does not exceed the cost of a Magnum biopsy gun: ~15,000,000 UGX (~$4000) and is within the budget range of high-level (6 & 7) hospitals in Uganda.8Device cost does not exceed cost of comparable devices on the Ugandan market. Specifically, our device scores an average score >= 3 over all consulted experts.
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VAL.02Assessing Skill RequirementEase of Mastery5.1 Requires fewer than 3 weeks of training to learn how to use the solution during the FNA procedure.Confidence level scores of trainees from one training session to the next exceed or match the score of the previous training session. No decrease in confidence between training sessions should be reported.
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VAL.03Accomodating HandednessEase of Mastery5.2 The device can be used regardless of handedness.Upon the Handedness test, our prototype yields a Handedness Index, as defined in our test method, of 2 or higher (Handedness Index >= 2).
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VAL.04Assessing ErgonomicsEase of Mastery5.2 The device can be used regardless of handedness.Ergonomic index, as defined in our test method, must be greater than or equal to 2 (Ergonomic index >= 2). This would indicate that on average, experts considered our device to possess the same level of ergonomic comfort or better in using our device, as compared to standard manual fine needle aspiration.
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VAL.05Assessing Sample Adequacy Under Clinical ConditionsSample Adequacy1.1 The needle provides additional automated agitation to the tissue of interest. The type of automated agitation and the parameters of this motion of agitation are still being determined through developmental testing.

1.2 The probability o f gathering an adequate sample (500-1000 diagnostic cells)16 within one pass through the lesion exceeds 11%.

Acceptance criteria will be determined based on results from DEV.01. More abstractly, since this test is intended to be done by a clinician, the clinician will evaluate whether the aspirated sample is adequate or not.
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