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To be used in treatment where whole body radiation therapy is indicated. The shielding tray reduces the radiation exposure to those organs, such as lungs, which are desired to be shielded.

The Dynamic Radiation Table, is a PC-controlled table which permits total body radiation and incorporates a series of moving tables or trays - one for the patient to lie on, protective organ shields tray and an attenuating tray. It incorporates a number of features such as x-ray trays for verification of radiation dose, number of safety features and limit switches.

The provided text describes a medical device, the "Dynamic Shielding Radiation Table," and its comparison to a predicate device for the purpose of a 510(k) submission to the FDA. However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is primarily a summary of safety and effectiveness, focusing on:

• Device Description: What the device is and how it works.
• Intended Use: The medical conditions and environment where the device is used.
• Comparison to Predicate Devices: Highlighting similarities and differences with existing legally marketed devices (Siemens ZXT Treatment Table).
• FDA Clearance Letter: Indicating that the device was found substantially equivalent to predicate devices.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about a study that proves the device meets acceptance criteria, as this information is not present in the provided text.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts, adjudication methods for a test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Details about standalone (algorithm-only) performance.
• The type of ground truth used.
• Sample size or ground truth establishment for a training set.
• Any mention of performance studies or acceptance testing beyond a feature-by-feature comparison to predicate devices and general safety features.

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