(165 days)
TrueBeam-TrueBeam STx-Edge:
The TrueBeam, TrueBeam STx, and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere radiation therapy is indicated for adults and pediatric patients.
The TrueBeam, TrueBeam STx, 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 tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic turnors (such as lung cancer, esophageal 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 carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast turnors, sarcomas, lymphoid tumors (such as Hodgkin's and non-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, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, and skull base tumors).
VitalBeam:
VitalBeam® is 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.
VitalBeam 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, optic nerve tumors, and skull based tumors), head and neck tumors primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal 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 carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous 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 elioma, evendymoma, pituitary tumors. hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyageal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).
The TrueBeam and VitalBeam Radiotherapy System is a medical linear accelerator that delivered therapeutic radiation to patient in accordance with the physician's prescription.
Here's a summary of the acceptance criteria and the study information based on the provided text, formatted to your requests. However, please note that the document is a 510(k) summary for a radiotherapy system, which focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It is not a clinical study of an AI/ML device, and therefore many of the requested fields related to AI performance, ground truth establishment, and expert involvement are not applicable or not provided in this type of document.
Acceptance Criteria and Device Performance
This document describes a medical device (TrueBeam, TrueBeam STx, Edge, and VitalBeam radiotherapy systems) that has undergone updates. The "acceptance criteria" here refer to conformance to regulatory standards and a demonstration of substantial equivalence to a predicate device, rather than performance metrics for an AI algorithm. The performance is assessed through verification, validation, and safety standards testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device with specific performance metrics like sensitivity, specificity, or AUC, the "performance" here refers to compliance with safety and functional standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Conformance to FDA Quality System Regulation (21 CFR §820) | Hardware and software verification and validation testing conducted, and confirmed conformance. |
| Conformance to ISO 13485 Quality Management System standard | Design and development, including verification and validation testing, conducted within an established Quality System compliant to EN ISO 13485:2016. |
| Conformance to ISO 14971 Risk Management Standard | Design and development, including verification and validation testing, conducted within an established Quality System compliant to EN ISO 14971:2012. Outcome: No Discrepancy Reports (DRs) remaining with a priority of Safety Intolerable. |
| Software documentation as per FDA Guidance | Provided documentation as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Software Safety Level | Software considered a "major" level of concern. |
| Biocompatibility (patient-contact materials) | No change to patient-contact materials biocompatibility in this medical device. Conformance to ANSI/AAMI/ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1" confirmed. |
| Human factors validation (IEC 62366) | Validation study conducted according to IEC 62366 to verify that the device "performs well as intended for the intended users, uses, and use environments." |
| Electrical safety (IEC 60601-1) | Testing conducted. System complies with IEC 60601-1 standards for safety. |
| Electromagnetic compatibility (EMC) (IEC 60601-1-2) | Testing conducted. System complies with IEC 60601-1-2 standard for EMC. |
| Conformance to other recognized standards (e.g., IEC 60601-2-1) | Conforms to various listed standards (e.g., IEC 60601-1-6, IEC 62304, IEC 60825-1, IEC 60601-1-3, IEC 61217, IEC 62274, ISO 10993-1, IEC 60601-2-68, ISO 15223-1). Full details refer to Summary of Use of Voluntary Consensus Standards document in Section 09. |
| Intended Use and Indications for Use | Unchanged from predicate device. |
| Principle of Operation | No changes from predicate device. |
| Safety Profile | Results of verification, validation, and safety standards testing demonstrate no changes to the safety profile of the device. Outcome: The product conformed to the defined user needs and intended uses, and there were no discrepancy reports (DRs) remaining which had a priority of Safety Intolerable. Therefore, the device is substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a regulatory submission for a radiotherapy system, not an AI/ML diagnostic or prognostic device that typically uses "test sets" of patient data for performance evaluation in the typical sense. The testing described is primarily hardware and software verification and validation, along with compliance to international standards. Therefore, information about a "sample size for a test set" or "data provenance" (country, retrospective/prospective) related to patient data for AI evaluation is not applicable and not provided in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that this is not an AI/ML device being evaluated for diagnostic or prognostic accuracy on patient data, the concept of "ground truth" and "experts establishing ground truth" in the context of a "test set" is not applicable here. The "experts" involved would be engineers, physicists, and regulatory specialists confirming compliance with technical and safety standards.
4. Adjudication Method for the Test Set
As this is not an AI/ML study involving human interpretation of data where adjudication is needed, an "adjudication method" is not applicable and not described in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done and is not relevant for this type of medical device submission. This document pertains to a radiotherapy treatment delivery system, not an AI-assisted diagnostic or interpretation tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
This is not applicable as the TrueBeam is a medical linear accelerator for radiation therapy delivery, not an AI algorithm intended for standalone performance evaluation in the way this question implies. Any "algorithms" (e.g., iCBCT reconstruction) are components of the system, and their performance is evaluated as part of the overall system's functional and safety requirements, not as standalone AI products.
7. The Type of Ground Truth Used
The "ground truth" in this context is the adherence to established engineering, safety, and regulatory standards, along with the device's functional specifications. It's established through:
- Engineering specifications and design documents: Dictating how the device should perform.
- International Consensus Standards: Like IEC 60601 series, IEC 62304, ISO 13485, ISO 14971, which define safety and performance requirements.
- Verification and Validation Testing: Empirical testing to confirm the device meets these specifications and standards.
- Clinical use (implied/previous predicate data): The safety and efficacy of radiation therapy itself, and the predicate device, form the basis. The current submission demonstrates that the updated device maintains that safety and efficacy.
It is not expert consensus on patient pathology, or outcomes data in the sense of a clinical trial for a novel AI diagnostic.
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI/ML system that undergoes "training" on a dataset in the typical machine learning sense. The development of the device follows traditional engineering design, verification, and validation processes. While some components like the iCBCT algorithm might involve data for development, the concept of a "training set" for the whole system, as understood for AI, isn't present in this document.
9. How the Ground Truth for the Training Set was Established
Since there is no "training set" in the AI/ML context for the device as a whole, this question is not applicable. In the case of component algorithms (like iCBCT), any "ground truth" for their development would be based on known physics, simulation data, and expert validation of imaging quality, but this detail is not provided in a 510(k) summary focused on substantial equivalence.
§ 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.