(70 days)
I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.
For clinical use, l2C must be integrated into a radiation therapy system. I2C will interact with components of the radiation therapy center. I2C supports the acquisition of 2D, 2D stereoscopic and 3D images using 2D detectors. I2C will be used by the clinical therapist to verify by imaging that the treatment target position received from the treatment control applicative laver is 'valid', i.e. that it brings the center of the treatment target volume at the isocenter of the therapy equipment with required accuracy. If it is not, InC will propose a correction shift - or correction vector - that will be exported to the radiation therapy system.
Here's a summary of the acceptance criteria and study information for the I2C device:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance / Technological Specification | Acceptance Criteria (Predicate Devices) | Reported Device Performance (I2C) |
|---|---|---|
| Generator operating range (radiographic) | 40-150 kVp | 40-150 kVp |
| Generator operating range (CBCT) | 60-140 kVp (OBI) | 40-125 kVp |
| Flat panel pixel size | 127 µm (Verisuite) / 194 µm (OBI) | 148 µm |
| Flat panel pixel matrix | 3200x3200 pixels (Verisuite) / 3200x2304 pixels (OBI) | > 2880x2880 pixels |
| CBCT scale & distance accuracy | 1% (OBI) | 1% |
| CBCT spatial resolution | 4-7 lp/cm (OBI) | At least 5 lp/cm |
| CBCT low contrast resolution | 15mm@1% (OBI) | 15mm@1% |
| CBCT numbers accuracy | +/- 40 HU (OBI) | +/- 40 HU |
| CBCT Uniformity | +/- 40 HU (OBI) | +/- 40 HU |
| Achievable matching accuracy |
§ 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.