Search Results

The IMAGEnet 5 PC Software System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon imaging devices through a direct connection with Topcon instruments or through computerized networks.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the IMAGEnet 5 PC Software System does not contain the detailed information necessary to answer your request about acceptance criteria, study details, and data provenance.

The document is a clearance letter, which confirms that the device is substantially equivalent to a predicate device and can be marketed. It states the indications for use but does not delve into the specifics of performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications that would be found in a study report or a more detailed submission.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance: This information is not present in the document.
2. Sample sizes, data provenance, number of experts, adjudication methods for the test set: These study design details are not included.
3. MRMC comparative effectiveness study results or effect size: This type of study detail is not in the provided text.
4. Standalone performance details: The document does not describe standalone algorithm performance.
5. Type of ground truth used: This is not mentioned.
6. Sample size for the training set: This is not mentioned.
7. How the ground truth for the training set was established: This is not mentioned.

Ask a specific question about this device