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The DIMS (Digital Imaging and Medical System) is intended to be used as a picture archiving and communications system during colposcopy procedures.

The DIMS (Digital Imaging and Medical System) is a picture archiving and communications system. Hardware components are purchased from other manufacturers. Two models will be provided, distinguished only by the size of their monitors. Software runs in the Windows 95 format.

This submission (K970813) for the DIMS (Digital Imaging and Medical System) does not contain any information regarding acceptance criteria or a study proving device performance in the manner requested.

The document explicitly states:

"Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The submission focuses on the device description, intended use, technological characteristics, and comparison to a legally marketed device (Wallach Digital Imaging System, K950630) for substantial equivalence. It confirms software testing was conducted as part of the development process but no performance or clinical evaluations proving efficacy or accuracy for its intended use were submitted.

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