(113 days)
Halcyon and Ethos Radiotherapy System are 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. The Halcyon and Ethos Radiotherapy System produce CBCT images that can be used in Image Guided Radiation Therapy, and the simulation and planning for adaptive radiation therapy.
Halcyon and Ethos Radiotherapy System are single energy medical linear accelerators (linacs) designed to deliver Image Guided Radiation Therapy and radiosurgery, using Intensity Modulated and Volumetric Modulated Arc Therapy techniques. They consist of the accelerator and patient support within a radiation shielded treatment room and a control console outside the treatment room.
The provided text describes a 510(k) premarket notification for the "Halcyon and Ethos Radiotherapy System." However, it does not contain the specific details regarding acceptance criteria for device performance or a detailed study proving the device meets these criteria in the format requested. The document primarily focuses on regulatory compliance, device description, intended use, significant differences from the predicate device, and non-clinical testing.
Here's a breakdown of what is and is not available in the provided text:
What's NOT available in the text:
- A table of acceptance criteria and reported device performance: The document mentions "Test results showed conformance to applicable requirements specifications" but does not provide the specific performance criteria or the quantitative results.
- Sample size for the test set and data provenance: No information on the number of images/patients used for testing or where the data came from (e.g., country, retrospective/prospective).
- Number of experts and their qualifications for establishing ground truth: No details about experts for ground truth.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of a human reader study or comparison with humans, with or without AI assistance.
- Standalone algorithm performance: While the document describes the software, it doesn't present performance metrics for the algorithm in isolation.
- Type of ground truth used: Not specified.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
What IS available from the text (related to the request):
- Device Name: Halcyon, Ethos Radiotherapy System
- Predicate Device: Halcyon, Ethos Radiotherapy System (K192377) - This implies that the current submission is for updates/modifications to an existing cleared device.
- Indications for Use (Modified from Predicate): "The Halcyon and Ethos Radiotherapy System produce CBCT images that can be used in Image Guided Radiation Therapy, and the simulation and planning for adaptive radiation therapy."
- Significant Differences (which necessitated the new submission):
- Cone Beam CT for Planning (CBCTp) with customizable protocols, guided workflow, interactive isocenter placement, patient marking, treatment position verification, and highly accurate HU specifications for dose calculation.
- High Performance Imaging (new hardware and software for 6-second kV CBCT acquisition, 6RPM gantry rotation, XL imager, new kV collimator, larger capacity x-ray tube, iCBCT-based metal artifact reduction, extended FOV up to 70 cm).
- Beam-Hold Interface for external motion compensation systems.
- Automatic mAs Detection.
- Non-Clinical Testing:
- "Verification of the capability of the modified software and hardware to produce CBCT image Guided Radiotherapy and simulation and planning for adaptive radiation therapy was completed."
- "Validation of the use of the modified CBCTp work flow was also performed."
- "image quality and dose calculation accuracy was assessed and compared with planning CT images for its suitability to support adaptive planning."
- Testing conducted according to FDA Quality System Regulation (21 CFR §820), ISO 13485, ISO 14971, and "FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"
- Software Level of Concern: "major" (failure could result in serious injury or death).
- Electrical safety and EMC testing compliant with IEC 60601-1 and IEC 60601-1-2.
- Conclusion: "The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable or Customer Intolerable." This is a general statement of meeting requirements, but not specific performance metrics.
- Ground Truth (implied): For the "image quality and dose calculation accuracy was assessed and compared with planning CT images for its suitability to support adaptive planning," the "planning CT images" would serve as a form of ground truth or reference standard for comparison. However, the details of this comparison are not provided.
In summary, the provided document does not contain the detailed study results and acceptance criteria in the requested format. It primarily confirms that non-clinical testing was performed and the device met its defined user needs and intended uses under regulatory guidelines for safety and performance, as compared to a predicate 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.