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The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy.

The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy.

The technological characteristics are similar to those found in the:

Varian Medical Systems Trilogy Radio Therapy System 510(k) K081188

HDRT software is based on Integra Radionics ImageFusion 3 software (K063230) in that it compares multiple 3D images. In the case of HDRT the images compared are: the pretreatment planning images obtained immediately before treatment. The images immediately before treatment are obtained from Varian Trilogy Linear Accelerators which incorporate CBCT devices capable of exporting DICOM images to shared drives. Based on the comparison of the images, HDRT specifies patient adjustment data, to insure that the patient is appropriately positioned for treatment. This functionality allows for slight errors in positioning of the patient to be compensated for, it also compensates for movement of internal organs.

This looks like a 510(k) premarket notification for a medical device called the Radionics XKnife HDRT System. It appears to be for a radiation therapy treatment planning system to aid in patient positioning.

Unfortunately, the provided text does not contain any information about acceptance criteria or specific studies proving the device meets those criteria. The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is the basis for 510(k) clearance. This means that the FDA determined the new device is as safe and effective as a legally marketed device, but the excerpt does not detail the testing and performance metrics that would typically be associated with proving independent acceptance criteria.

Therefore, I cannot provide the requested information. The document mentions:

• Trade Name: Radionics XKnife HDRT System
• Common Name: Radiation Therapy Treatment Planning System
• Indications for Use: To aid in the positioning of patients immediately prior to therapy.
• Technological Characteristics: Compares multiple 3D images (pre-treatment planning images and images obtained immediately before treatment from CBCT devices on Varian Trilogy Linear Accelerators). Specifies patient adjustment data based on image comparison.
• Predicate Device: Varian Medical Systems Trilogy Radio Therapy System (K081188) and Integra Radionics ImageFusion 3 software (K063230) for image comparison functionality.

To answer your specific questions, information regarding acceptance criteria, device performance results, sample sizes for test/training sets, ground truth establishment, expert involvement, or MRMC studies for this device is not present in the provided text.

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