(87 days)
The RadioCameras™ Biteblock Positioning and Localization System is indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The RadioCameras™ System provides precise localization of the treatment isocenter relative to the LINAC isocenter.
This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures on cranial lesions. The RadioCameras™ System uses fiducial markers on a biteblock to localize the treatment site on CT or MR scans and optical tracking of infrared markers on the biteblock as the method of locating the position of the treatment isocenter relative to the LINAC isocenter. The RadioCameras™ System consists of a camera array, computer workstation, a biteblock optical positioner, and an optical calibration jig.
The provided text describes the RadioCameras™ Biteblock Localization and Positioning System and states its substantial equivalence to predicate devices. However, the document does not contain the specific details required to complete your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Information on sample size, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Details about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Results of a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
The document is a 510(k) summary for regulatory clearance, which focuses on demonstrating substantial equivalence rather than providing a detailed technical study report with performance metrics against predefined acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and study details based on the provided input.
§ 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.