(85 days)
iPlan RT Image's indications for use are to prepare and present patient and image data based on CT, MR, angiographic and other imaging sources including
- image preparation -
- image localization
- n image fusion
- image segmentation "
- isocenter handling -
- plan review and approval -
where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.
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The provided text is a 510(k) summary for the iPlan RT Image device from BrainLAB AG. This document focuses on establishing substantial equivalence to predicate devices and detailing the intended use. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.
Therefore, I cannot provide the requested information from this document. The sections you asked for, such as "A table of acceptance criteria and the reported device performance," "Sample sized used for the test set," "Number of experts used," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "training set sample size," and "how ground truth for training set was established," are not present in the provided text.
§ 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.