(162 days)
IDENTIFY is indicated for patient and accessory identification, positioning and tracking for imaging and radiation therapy treatments.
Identify is used for patient-setup, guidance and to monitor a patient before and during radiation treatment. The system consists of cameras, software, PC workstations, RFID kit, Interlock unit, calibration tools, Palm scan unit, RFID tags and optical markers, network components and cabling and handheld controllers.
The provided text is a 510(k) summary for Varian Medical Systems' "Identify" device. It outlines the device's intended use, classification, and non-clinical testing. However, it does not contain a detailed study report that includes specific acceptance criteria and device performance metrics, sample sizes, ground truth establishment methods, or any information regarding multi-reader multi-case comparative effectiveness studies.
The document focuses on demonstrating substantial equivalence to a predicate device (Identify K112692) through compliance with various quality and safety standards.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other specific study details based on the information given. The text explicitly states:
- "Non-clinical Testing Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards listed below. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly."
- "The outcome was that the product conformed to the defined uses and that there were no DRs (discrepancy reports/Unresolved Anomalies) remaining which had a priority of Safety Intolerable or Customer Intolerable."
This indicates that internal verification and validation testing was performed to affirm compliance with regulations and standards, but it does not detail a study designed to measure performance against specific clinical or technical acceptance criteria with quantified results. The document emphasizes "conformance to applicable requirements specifications" rather than presenting specific performance metrics.
§ 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.