(39 days)
The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery 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: bram and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as ung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavemous malformation, trigeninal 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, pitutary 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.
This document describes the regulatory submission for the TrueBeam and Edge Radiotherapy Delivery System. The acceptance criteria and supporting studies are based on performance testing and adherence to recognized standards, rather than direct clinical performance data from a specific study with clearly defined performance goals like sensitivity/specificity.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance/Verification Method |
|---|---|
| Safety and Effectiveness (General) | 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 other FDA recognized consensus standards. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. |
| Software Level of Concern | Software for this device was classified as a "major" level of concern. Verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Biocompatibility | Biocompatibility evaluation for patient-contact materials was conducted in accordance with FDA Blue Book Memorandum #G95-2 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Device Part 1: Evaluation and Testing,'" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process." |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Electrical safety and electromagnetic compatibility (EMC) testing were conducted. The system complies with IEC 60601-1 standards for safety and IEC 60601-1-2 standard for EMC. |
| Conformance to Recognized Standards | The TrueBeam™, TrueBeam STx™ and Edge™ medical linear accelerators conform in whole or in part with the following FDA recognized consensus standards: AAMI/ANSI/IEC 60601-1:2005, ANSI/AAMI/ISO 10993-1:2003, IEC 60601-1-2:2007, IEC 60601-1-3:2008, IEC 60601-1-6:2010, IEC 60601-2-1:2009, IEC 60601-2-32:1994, IEC 60601-2-44:2009, IEC 60825:2007, IEC 60976:2007, IEC 61217:2011, IEC 62304:2006, IEC 62274:2005, IEC 62366:2007. |
| Technological Equivalence (Improvements) | The device incorporates new features compared to its predicate: 80-leaf MLC (vs. not present in predicate) and Manual bolus verification (vs. not present in predicate). These changes are presented as advancements that maintain or improve safety and effectiveness. |
| Substantial Equivalence to Predicate Device (K140528: TrueBeam Radiotherapy System and Accessories) | The results of verification, validation, and safety standards testing demonstrate that the TrueBeam, TrueBeam STx, and Edge are substantially equivalent to their predicate device. This is the overarching "acceptance criterion" for 510(k) submissions, where the new device is shown to be as safe and effective as a legally marketed predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document extensively references hardware and software verification and validation testing, biocompatibility evaluation, and electrical safety and EMC testing. These types of tests typically involve controlled laboratory environments and specific test protocols rather than human patient data sets in the way clinical studies for diagnostic algorithms would.
- Test Set Sample Size: The document does not specify a "sample size" in terms of patient data. Instead, the "sample" for testing would be the device itself and its components. For software testing, it would involve test cases and scenarios designed to cover various functionalities and potential failure modes. For hardware, it would be the physical units and their sub-assemblies. The scale of these tests is not quantified in the provided text.
- Data Provenance: Not applicable in the context of patient data. The provenance relates to the testing environment and standards adherence rather than patient demographics or origin.
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)
This information is not provided. For this type of device (a radiotherapy delivery system), "ground truth" is established through engineering specifications, scientific principles, and adherence to recognized standards for performance, safety, and effectiveness, not through expert consensus on medical images or patient outcomes in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, the "test set" refers to engineering and software validation, not a clinical study involving expert adjudication of medical findings.
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 is a radiotherapy delivery system, not an AI-assisted diagnostic tool designed to be used by human readers for interpretation. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not an "algorithm only" device in the sense of a diagnostic AI. It is a medical device system that includes algorithms for its operation and control. The performance described here is the integrated system's conformance to safety and performance standards, which implicitly includes the performance of its internal algorithms as part of the overall system. The testing described (hardware and software verification/validation) assesses the device's standalone performance according to its specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's validation is established by:
- Engineering specifications and design requirements: The device is designed to meet specific technical parameters and safely deliver radiation.
- International and national standards: Compliance with standards like IEC 60601 series, ISO 13485, ISO 14971, ISO 10993-1, and FDA's quality system regulations. These standards define accepted benchmarks for safety, performance, and manufacturing quality.
- Predicate device equivalence: The device is considered "substantially equivalent" to an already cleared device (K1405528), meaning its performance characteristics are comparable and it raises no new questions of safety or effectiveness.
8. The sample size for the training set
Not applicable. This document describes a medical device, not a machine learning model that requires a "training set" of data for learning.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of 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.