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XKnife RT 3 with Non-Stereotactic Module is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic, collimated beam, computer planned, LINAC based treatment.

The device is a module of the XKnife RT system that allows radiotherapy treatment planning using non-stereotactic CT image sets. As in traditional radiation treatment planning, external fiducial markers (rather than a stereotactic frame) now provide a reference from which an isocenter may be specified.

The provided text describes a 510(k) summary for the Radionics XKnife RT 3 with Non Stereotactic Module. However, it does not contain any information about acceptance criteria, device performance metrics, or study details (sample size, ground truth, expert qualifications, adjudication, MRMC, or standalone performance).

The document primarily focuses on:

• Identification of the submitter and device: Radionics XKnife RT 3 with Non Stereotactic Module.
• Predicate devices: XPlan 2.2 with the Body Module, XKnife RT System, Stereotactic KTF System.
• Device description: A module for the XKnife RT system that allows radiotherapy treatment planning using non-stereotactic image sets (e.g., CT scans) where anatomical landmarks, rather than a stereotactic frame, define the isocenter.
• Intended Use/Indications for Use: Radiosurgery and radiotherapy treatment for stereotactic and non-stereotactic, collimated beam, computer-planned, LINAC-based treatment.
• Statement of testing: "Sufficient testing has been completed to insure that the module can import, localize and generate a treatment plan using a non-stereotactic CT scan."

Without specific numerical acceptance criteria, performance metrics, or study design details, I cannot fill out the requested table or answer the other questions. The document only makes a general statement that "sufficient testing has been completed."

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