(90 days)
The Leibinger system for non-invasive fixation is intended for patient positioning and immobilization, stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets.
The Leibinger system for non-invasive fixation is intended for patient positioning and immobilization, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.
Not Found
This submission does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.
The document is a 510(k) summary for a "Non-Invasive Patient Fixation System." It declares substantial equivalence of the device to existing patient fixation systems.
Here's a breakdown of why the requested information cannot be provided from the given text:
- No acceptance criteria are mentioned. The document focuses on demonstrating substantial equivalence to predicate devices, not on specific performance metrics or thresholds.
- No study proving the device meets acceptance criteria is described. The 510(k) summary lists the intended use and states that the device "does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed." This implies a comparison to existing devices rather than a detailed performance study against defined criteria.
Therefore, many of the specific points requested (sample size, data provenance, ground truth establishment, MRMC study, standalone performance) are not applicable or not present in this type of regulatory filing.
The document is a regulatory submission for premarket notification (510(k)), typically used for devices that are substantially equivalent to a legally marketed predicate device, rather than a detailed clinical or technical study report.
§ 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.