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The WebRad Computed Radiography Quality Assurance (CR/QA) Workstation is a Web based software product that will allow the user to view computed radiography images acquired from a FUJI Computed Radiography System and other imaging modalities.

WebRad Computed Radiography Quality Assurance (CR/QA) Workstation is a Web based software product.

This document is a 510(k) clearance letter from the FDA for the WebRad Computed Radiography Quality Assurance (CR/QA) Workstation, dated April 2, 1998. It primarily confirms substantial equivalence to a predicate device and outlines general regulatory obligations.

Crucially, the provided text does not contain any information regarding specific acceptance criteria for the device's performance, nor does it detail any studies conducted to prove the device meets such criteria.

Therefore, I cannot fulfill your request for the detailed information as the document lacks it.

Here's a breakdown of why I cannot answer your specific points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The letter is a regulatory clearance, not a performance report.
2. Sample sized used for the test set and the data provenance: Not present. No study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No study details are provided.
4. Adjudication method for the test set: Not present. No study details are provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not present. No study details are provided.
6. If a standalone performance was done: Not present. No study details are provided.
7. The type of ground truth used: Not present. No study details are provided.
8. The sample size for the training set: Not present. No information about AI/ML models or training sets is included.
9. How the ground truth for the training set was established: Not present. No information about AI/ML models or training sets is included.

The document only states that the WebRad system is a "Web based software product that will allow the user to view computed radiography images acquired from a FUJI Computed Radiography System and other imaging modalities." The FDA determined it to be "substantially equivalent" to predicate devices, which means it has the same intended use and technological characteristics as a legally marketed device without raising new questions of safety and effectiveness. This determination does not inherently require a detailed performance study with acceptance criteria to be submitted or described in the clearance letter itself.

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