(30 days)
The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
The TrueBeam and Edge Systems may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck turnors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinomaly tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).
The TrueBeamTM Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device.
The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
The provided text describes the regulatory clearance for the Varian TrueBeam, TrueBeam STx, and Edge Radiotherapy Delivery Systems but does not contain information about acceptance criteria or a study proving device performance against such criteria.
The document is a 510(k) premarket notification decision letter from the FDA, along with the device's Indications for Use and a 510(k) summary. It primarily addresses the substantial equivalence of the new devices to a previously cleared predicate device (K162472).
Here's what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance:
- Not provided. The document focuses on regulatory compliance and equivalence to a predicate device, not on specific performance metrics or acceptance criteria for a validation study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. There is no mention of a test set with patient data. The "testing" referred to is primarily hardware and software verification and validation, as well as adherence to safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This information is for studies involving interpretation or diagnosis, which is not the focus of this clearance document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As above, this is for studies involving interpretation or diagnosis.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a radiotherapy delivery system, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware and software system for delivering radiation therapy, not a standalone algorithm in the sense of AI for diagnosis or interpretation. The document mentions software verification and validation, but this is for the control of the device, not for an autonomous diagnostic function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. Ground truth, in the context of diagnostic or interpretive AI, is not relevant to this device's clearance. The "ground truth" for a radiotherapy delivery system would relate to its physical performance (e.g., dose delivery accuracy, beam shaping accuracy) which is assessed through engineering tests and phantom measurements, not human-read data.
8. The sample size for the training set:
- Not provided. This device is not an AI/ML model that would have a "training set" in the typical sense. Its software is developed and validated against requirements and specifications, not trained on data to learn a task.
9. How the ground truth for the training set was established:
- Not applicable. No training set as per the typical understanding of AI/ML.
Summary of available information related to validation/testing from the provided document:
- Type of Testing: Hardware and software verification and validation testing, as well as conformance to FDA Quality System Regulation (21 CFR §820), ISO 13485 (Quality Management System), ISO 14971 (Risk Management), and other FDA recognized consensus standards (listed in the table on page 4). This includes electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2).
- Software Level of Concern: The software for this device was considered "major" level of concern, meaning "A failure or latent flaw in the software could directly result in serious injury or death to the patient or operator."
- Conclusion: The tests demonstrated "conformance to applicable requirements specifications and assured hazard safeguards functioned properly." The conclusion states that the devices are substantially equivalent to their predicate device based on these tests.
In essence, the provided document is a regulatory approval notice based on demonstrating safety, effectiveness, and substantial equivalence to a predicate device through engineering validation and adherence to recognized standards, rather than a clinical performance study with specific acceptance criteria for diagnostic accuracy or similar 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.