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This device is intended for mounting blocks and/or compensators/modulators for insertion into a Linear Accelerator head.

Blocking Trays are to be used as an accessory to a Linac. Custom blocks are mounted onto Blocking trays and slid into the Linac into their accessory holder thereby stenciling the radiation beam onto the patient. Compensators are also mounted on blocking trays and slid into the Linac changing the radiation beam fluence unique to a patient's anatomy.

This 510(k) submission does not contain information on acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a "Blocking Tray" accessory to a Linac, and the FDA's response indicating substantial equivalence to predicate devices.

The document primarily focuses on:

• Device Name: Blocking Tray
• Intended Use: For mounting blocks and/or compensators/modulators for insertion into a Linear Accelerator head.
• Technological Characteristics: References internal documents (DMR-02 Device Master Record, PD-02 Processing a Blocking Tray Work Order, Acrylic MSDS, Polycarbonate MSDS) which are not provided.
• Predicate Devices: A list of previously cleared accessory devices from various manufacturers.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, or study details because it is not present in the provided text.

This type of 510(k) summary typically establishes substantial equivalence by demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, and does not raise different questions of safety and effectiveness. It does not generally include detailed performance studies with acceptance criteria in the public summary document itself, especially for such a relatively simple accessory device.

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