(20 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.
This document is a 510(k) Premarket Notification for the IDENTIFY device from Varian Medical Systems, referencing K192968. It details the device's indications for use, its description, and its claim of substantial equivalence to a predicate device (IDENTIFY K190137) based on non-clinical testing.
Unfortunately, the provided text does not contain the detailed acceptance criteria or the specific study that proves the device meets these criteria in the format requested. The document primarily focuses on regulatory compliance, product description, and a general statement about non-clinical testing outcomes.
Specifically, the following information is missing from the provided text:
- A table of acceptance criteria and reported device performance. The document states "Test results showed conformance to applicable requirements specifications" but does not define these specifications or provide quantitative results.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states:
"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."
And:
"The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports/Unresolved Anomalies) remaining which had a priority of Safety Intolerable or Customer Intolerable. Varian therefore considers Identify to be safe and to perform at least as well as the predicate device."
These are general statements about the completion and success of V&V testing, but they do not provide the granular data requested in your prompt regarding specific acceptance criteria and detailed study results. The submission relies on demonstrating conformity to standards and the absence of critical discrepancies, rather than presenting a detailed performance study with quantitative acceptance 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.