HTT MDDT
- Version 4
- by (unknown)
- Version 5
- by (unknown)
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3 | - | == HTT and the Medical Device Development Tool |
+ | == HTT and the Medical Device Development Tool Submission ==
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5 | We are crowdsourcing pathologists to collect data (images + pathologist annotations) that can be qualified by the ''' [MedicalDeviceDevelopmentTools FDA/CDRH medical device development tool (MDDT) program]'''. If successful, the MDDT qualified data, along with a statistical software package for data the analysis, will be available to any algorithm developer to be used to validate their algorithm performance in a submission to the FDA/CDRH. | |||
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7 | - | + | ==== Original Proposal ====
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9 | - | We |
+ | Here is the original proposal submitted 15 November 2019.
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10 | + | * [[File(00_MDDTproposal_TILsAnnotatedDataset_Gallas-public.pdf)]]
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12 | + | We received feedback from FDA on 16 April 2020. We intend to summarize the feedback and how we have adapted our efforts. |