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The DX-480 Imager Unit is a solid-state ( electronic ) x-ray acquisition device designed to replace film-cassettes used in conventional x-ray processes. The imager is designed to be mounted in a wide variety of positioning devices such as floating tables, swing-arm assemblies, and upright stands.

The DX-480 Imager Unit is a solid-state ( electronic ) x-ray acquisition device designed to replace film-cassettes used in conventional x-ray processes. The imager is designed to be mounted in a wide variety of positioning devices such as floating tables, swing-arm assemblies, and upright stands.

This FDA 510(k) clearance letter (K981880) for the DX-480 Add-on Digital Imager determines substantial equivalence to a predicate device. However, the provided document does not contain any information regarding acceptance criteria, device performance metrics, or details of a study used to validate the device's performance.

The letter primarily focuses on:

• Confirming the review of the 510(k) notification.
• Determining substantial equivalence to a legally marketed predicate device.
• Outlining regulatory classifications and general controls applicable to the device.
• Providing contact information for regulatory compliance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in the 510(k) summary or other supporting documentation submitted to the FDA, which is not included in the provided text.

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