(99 days)
Halcyon is indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated for adults and pediatric patients.
Halcyon is a single energy medical linac designed to deliver Image Guided Radiation Therapy and Radiosurgery, using Intensity Modulated and Volumetric Modulated Arc Therapy techniques. It consists of the accelerator and patient support within a radiation shielded treatment room and a control console outside the treatment room.
This document is a 510(k) Premarket Notification for the Halcyon medical linear accelerator. It describes the device, its intended use, and non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on the regulatory submission process, demonstrating safety and effectiveness through non-clinical testing and conformance to standards, rather than reporting specific performance metrics against pre-defined acceptance criteria for a clinical study. The conclusion states that "the product conformed to the defined user needs and intended uses."
Therefore, a table of specific acceptance criteria and reported device performance (e.g., accuracy, precision) in the context of a clinical study cannot be extracted from this document. The document primarily discusses:
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Conformance to Safety Standards | Complies with IEC 60601-1 for safety. |
| Conformance to EMC Standards | Complies with IEC 60601-1-2 for EMC. |
| Conformance to Quality Systems | Conducted according to FDA Quality System Regulation (21 CFR §820), ISO 13485, ISO 14971, and other FDA recognized consensus standards. |
| Software Safety/Functionality | Software V&V conducted and documentation provided; considered "major" level of concern. No remaining Safety Intolerable or Customer Intolerable Discrepancy Reports (DRs). |
| Equivalence to Predicate | The device is considered as safe and effective and to perform at least as well as the predicate device (TrueBeam 2.7). |
2. Sample Size Used for the Test Set and the Data Provenance:
This document does not describe a clinical test set with human patient data or samples. The testing described is primarily non-clinical verification and validation (V&V) of hardware and software, and conformance to engineering and safety standards. Therefore, information about sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or available in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
As no clinical test set is described, information about experts for ground truth establishment is not applicable to this document. The "ground truth" for the non-clinical testing would be the specifications and requirements defined for the device's development.
4. Adjudication Method for the Test Set:
Given the absence of a clinical test set, an adjudication method is not applicable to this document.
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:
This document describes a medical linear accelerator, which is a device for radiation therapy delivery. It is not an AI-driven diagnostic or image interpretation device that would typically involve a multi-reader, multi-case study to assess human reader improvement with AI assistance. Therefore, no MRMC study or effect size is reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
The Halcyon is a medical device for treatment delivery, not a standalone algorithm. While it contains software, the "standalone performance" in this context refers to the device's ability to accurately deliver radiation according to a treatment plan, which is what the non-clinical V&V aimed to demonstrate. There is no mention of a separate standalone algorithm performance study in the way it's typically discussed for AI/ML diagnostic tools.
7. The Type of Ground Truth Used:
For the non-clinical testing described, the "ground truth" implicitly refers to:
- Engineering specifications and requirements: The device was tested against its design specifications and functional requirements.
- Standard compliance: The device's performance was compared against the requirements of various international standards (e.g., IEC 60601 series, ISO 13485, ISO 14971).
- Predicate device performance: The claim of "at least as well as the predicate device" suggests that the predicate's known performance serves as a benchmark.
8. The Sample Size for the Training Set:
This document does not describe an AI/ML model that would have a "training set" in the conventional sense of machine learning for diagnostic or predictive tasks. The software development follows traditional V&V processes, not a data-driven training paradigm with a specific training set size.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" described for an AI/ML model, the establishment of ground truth for such a set is not applicable to this document. The "ground truth" for the device's software and hardware development is established through its design specifications, regulatory standards, and established engineering principles.
§ 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.