RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE

• K Number: K041997
• Device Name: RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
• Manufacturer: RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
• Date Cleared: 2004-08-27 ( 32 days)
• Product Code: MUJ
• Regulation Number: 892.5050
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K981055 , K032724

Intended Use

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.

Device Description

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.

AI/ML Overview

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."

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.