(28 days)
The CT Sim Laser System is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the isocenter in the CT suite. The Gammex CT Sim is intended to read laser positioning coordinates in a Gammex specified software format from a file in a shared folder. Typically the coordinates were calculated by a Radiation Therapy Treatment Planning System (RTPS) using CT images and sent to the Hospital Information System (HIS), Oncology System (OIS) or other system, by the RTPS.
The CT Sim Laser System allows the radiation oncologist, medical physicist and oncology technician to precisely mark a patient for radiation therapy. CT Sim provides the ability to move the lasers to particular coordinates for alignment/marking purposes on the patient. The coordinates that the lasers are to move to may be manually input through the software graphical user interface (GUI) or through a data file with a specific format (or DICOM). CT Sim is in no way integrated with the third party Radiation Therapy Treatment Planning System (RTPS) or imaging/radiological device. The primary technological characteristics of the CT Sim Laser System is usage of movable lasers, a handheld keypad, a power/control box, and a PC controller, which are operated by the CT Sim software to indicate isocenter in the CT suite.
I am sorry, but the provided text does not contain detailed acceptance criteria or a study that proves the device meets specific acceptance criteria in a quantitative manner.
The document is a 510(k) premarket notification summary for the "CT Sim Laser Alignment System." It states that the device has been bench tested and performs within its design specifications and equivalently to predicate devices. However, it does not provide:
- A table of specific quantitative acceptance criteria.
- Reported device performance values against those criteria.
- Information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance details, or ground truth establishment for either test or training sets.
The relevant section, "5 Performance Data and Comparison with Predicate" (page 5), only generically states: "The CT Sim Laser System has been tested using appropriate bench testing methods. Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate devices." This is a general statement of compliance, not a detailed report of a study with specific results.
§ 892.5780 Light beam patient position indicator.
(a)
Identification. A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.