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The PLATINUM Image Reading, Review & Analysis Workstation is an image display workstation that is intended for use by qualified physicians for reading, reviewing and analyzing computerized digital images and reports acquired from imaging devices such as CT, MRI or computed radiography systems. PLATINUM is used to view digital images which are obtained either from a GE PACS System or a DICOM device, i.e. Acquisition, Archive or Workstation.

The PLATINUM Reading, Review & Analysis Workstation is a medical image display workstation intended to assist radiologists in making diagnoses.

The provided text describes a medical device, the "PLATINUM Reading, Review & Analysis Workstation," which is a PACS workstation. However, it does not contain a study proving the device meets specific acceptance criteria.

Instead, the document is a 510(k) premarket notification summary submitted to the FDA in 1998, indicating the device's substantial equivalence to previously marketed devices. This type of submission generally does not require extensive clinical studies with specified acceptance criteria in the same way a novel high-risk device might. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because that information is not present in the provided text.

Here is a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The document states a general intent for the workstation to "assist radiologists in making diagnoses" and its similarity in "intended use and technological characteristics" to predicate devices, but no quantifiable performance metrics or acceptance criteria are given.
2. Sample size used for the test set and the data provenance: No test set is described. The document discusses regulatory compliance and substantial equivalence, not a performance study data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
4. Adjudication method: Not applicable as no test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a PACS workstation, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a display workstation for human readers, not an algorithm performing a standalone diagnosis.
7. The type of ground truth used: Not applicable as no performance study requiring ground truth is described.
8. The sample size for the training set: Not applicable as training sets are associated with algorithms or AI, which this device is not.
9. How the ground truth for the training set was established: Not applicable.

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