(28 days)
The 4DITC function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
The 4D Integrated Treatment Console (4DITC) has been modified to add a new capability called Patient Accessory Verification System (PAVS). PAVS is a feature set of 4D ITC that enhances treatment safety. This feature allows users to identify accessories (not connected to the linac) for patients and interlock the radiation beam until these devices have been acknowledged by the end-user. Also, PAVS allows patient verification between the patient on the treatment schedule with the patient in the treatment room. This is accomplished using a hand-held bar code scanner used in conjunction with software by trained clinical staff. Staff defines which accessories require a bar code label to be scanned. Clinical staff creates the labels for the accessories using label creation software in Practice Management and a label printer. Staff scans the appropriate accessories for each patient's treatment field for accessory selection verification.
The provided text is a 510(k) summary for a medical device (4D Integrated Treatment Console with Patient Accessory Verification System - PAVS). However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document primarily focuses on:
- Device identification: Proprietary name, classification name, common name, predicate device.
- Device description: An explanation of the 4D Integrated Treatment Console (4DITC) and its new feature, Patient Accessory Verification System (PAVS), which enhances treatment safety by verifying patient accessories and patient identity using a bar code scanner.
- Indications for Use: Describes the purpose of the 4DITC in assisting radiation therapy operators with accurate treatment setups by monitoring parameters and preventing irradiation if parameters are out of conformance.
- Regulatory information: Mentions the FDA's review and determination of substantial equivalence to a predicate device, regulatory class, and general controls.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this data is not present in the provided text.
The text states "Refer to the Substantial Equivalence Comparison Chart" under the "Technological Characteristics" section, but this chart is not included in the provided document. Such a chart or other sections of the 510(k) submission would typically contain performance data and acceptance criteria.
§ 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.