(67 days)
The Trilogy™ Radiotherapy Delivery System is a radiation therapy accelerator intended deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.
The modified 2300C/D, which will now be called the Trilogy™ Radiotherapy Delivery System, will include stereotactic functionality and remote couch motions as new features. The Trilogy™ Radiotherapy Delivery System is an image-guided, dual-energy, high-dose medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy and intensity modulated radiosurgery. The Trilogy™ system delivers megavoltage x-ray mountated fucilobargery. The treatment of cancer. The Treatment of cancer. The Trilogy™ system includes a dynamic multileaf collimator (Millennium™ MLC with Dynamic MLC software), electronic portal imaging device (AS1000™), asymmetric jaws, enhanced dynamic wedge, a stereotactic treatment delivery mode (6MV, 1000 MU/min, maximum field size of 15cm x 15cm) and remote couch motion. There will be a 0.75mm radius isocenter for all three rotational axes, which include the gantry, collimator and table axes. The Trilogy™ system will allow for stereotactic treatments that may be intracranial or extracranial and consist of single-session or fractionated delivery. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary turnors and metastases.
The provided text is a 510(k) Summary for the Varian Medical Systems Trilogy Radiotherapy Delivery System. This document focuses on demonstrating substantial equivalence to predicate devices and describes the device's features and intended use. It does not contain information about acceptance criteria or specific studies proving the device meets those criteria in the way a clinical performance study for a diagnostic AI device would.
The Trilogy Radiotherapy Delivery System is a medical linear accelerator for radiation therapy, not a diagnostic AI device that generates a "reported device performance" against "acceptance criteria" through a traditional clinical study with a test set, ground truth, and expert adjudication in the manner typically associated with AI/ML medical devices.
Therefore, I cannot populate the requested table and sections. The 510(k) pathway for this device, approved in 2003, predates the typical framework for evaluating AI/ML medical devices. The "study" referenced in K03343 refers to engineering and performance testing to ensure the device operates as intended and meets safety standards, not a clinical study to establish diagnostic performance.
Key reasons for not being able to fulfill the request as specified:
- Type of Device: The Trilogy system is a treatment delivery device (a linear accelerator), not a diagnostic AI device. Its regulatory submission focuses on engineering specifications, safety, and substantial equivalence to existing similar devices (predicates).
- Approval Year: The K03343 submission was approved in 2003, well before specific regulatory guidance and common practices for AI/ML device evaluation were established, especially regarding clinical performance metrics like sensitivity, specificity, or reader improvement.
- Lack of Performance Data: The provided 510(k) summary does not include data like sensitivity, specificity, AUC, or other performance metrics typically associated with AI/ML diagnostic tools. Instead, it describes technical features (e.g., isocenter radius, maximum field size, dose rates) and clinical applications (types of radiation therapy and lesions).
- No "Ground Truth" for Performance: For a treatment delivery device, "ground truth" isn't established in the same way as for a diagnostic device (e.g., pathology for a cancer detection AI). Validation focuses on accurate and precise delivery of radiation according to planned parameters.
- No "Test Set" of Patients/Images: The concept of a "test set" and "training set" with expert-adjudicated ground truth, as posed in the prompt, does not apply to this type of device according to the provided documentation.
In summary, the provided document describes a traditional medical device (radiation therapy accelerator) and its 510(k) clearance process, which does not involve the specific types of performance studies, acceptance criteria, or ground truth methodologies requested for an AI/ML device.
§ 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.