(29 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 the Varian Medical Systems "Identify" device. It focuses on regulatory compliance, non-clinical testing, and an argument for substantial equivalence to a predicate device. Critically, it does not include details on acceptance criteria and a study proving the device meets those criteria, especially in the context of clinical performance or the improvement of human readers with AI assistance.
The "Identify" device, as described, is for patient and accessory identification, positioning, and tracking for imaging and radiation therapy. The description of its components (cameras, software, RFID, optical markers) suggests it's a patient localization and monitoring system, not primarily an AI-driven image analysis tool for diagnosis or decision support.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance: This document does not specify quantitative performance metrics or acceptance criteria for accuracy, precision, or other operational parameters of the "Identify" system. It mentions conformance to standards and "no DRs remaining which had a priority of Safety Intolerable or Customer Intolerable," which are general quality and safety statements, not specific performance criteria.
- Sample size and data provenance for a test set: No test set is described in terms of patient data or clinical cases. The testing seems to be focused on hardware/software verification and standard compliance.
- Number of experts and qualifications for ground truth establishment: Not applicable, as there's no mention of a human-read test set or ground truth established by experts.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: No such study is mentioned. The device's function as described (patient tracking) does not lend itself to an MRMC study comparing human reader performance with and without AI assistance in the diagnostic sense.
- Standalone (algorithm only) performance: No such
performance metrics are provided for an AI algorithm. The device is a system. - Type of ground truth used: Not clearly defined in the context of clinical performance data.
- Sample size for the training set: Not applicable, as there's no mention of a machine learning model training set with clinical data.
- How the ground truth for the training set was established: Not applicable.
Summary of available information related to testing:
- Non-clinical Testing: Hardware and software verification and validation testing were conducted according to FDA Quality System Regulation (21 CFR §820), ISO 13485, ISO 14971, and other FDA-recognized consensus standards (IEC 62304, ISO 15223-1, IEC 60601-1, IEC 60601-1-2, IEC 61217, AAMI RT2, IEC 62366-1).
- Software Level of Concern: "Major," indicating that a failure could result in serious injury or death.
- Electrical Safety and EMC: Complies with IEC 60601-1 and IEC 60601-1-2.
- Conclusion: "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 (applicable to the US)."
This document describes a device approval process based on substantial equivalence, primarily supported by adherence to recognized standards and internal V&V testing, rather than a clinical performance study with defined acceptance criteria and human-in-the-loop evaluations typically seen for AI-diagnostic devices.
§ 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.