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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 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.
An electron gun generates electrons which are accelerated by radio frequency (RF) power from a magnetron. The electrons strike a tungsten target producing photons (X-rays) for treatment and MV Imaging. The photons produced by the target are monitored and controlled by a pressurized ion chamber.
A beam collimation subsystem consisting of a primary and secondary collimator and two stacked multileaf collimators (MLCs) shapes the photon beam to define the treatment area.
X-Ray images of the patient are used by the treater to verify the correct treatment location. MV Imaging uses the treatment beam and a flat panel imager whereas kV imaging uses a high-capacity kV X-ray tube, a kV collimation system with full fan bowtie filter with movable y-blades to define the imaging beam size and to capture the image, a kV imager.
Halcyon and Ethos radiotherapy system deliver a treatment generated by a Treatment Planning System from a physician's prescription. kV CBCT images from HyperSight can additionally be used for planning treatments. Ethos radiotherapy system is capable of delivering adaptive treatments which can take into account changes in tumour geometry between treatment sessions.

The provided text describes a 510(k) submission for the Halcyon and Ethos Radiotherapy System, focusing on expanding the indications for use of its HyperSight CBCT images for primary treatment planning, effectively proving it is clinically equivalent to plans generated from conventional and simulator CT images.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: 26 human subject cases.
• Data Provenance: Obtained from three institutions in the US and Europe. The data was from institutionally approved prospective single-site clinical studies. All cases were adult patients planned to receive radiation therapy for head/neck, thorax (including breast), abdomen, or pelvis conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The text states that for each case, a "summary list identifying the dosimetrist and physician involved with each case" was provided. It does not specify the exact number of experts involved in establishing ground truth (e.g., contours, clinical planning objectives) for the test set, nor their specific qualifications (e.g., years of experience).

4. Adjudication method for the test set:

• The text does not explicitly describe an adjudication method for the test set data. It mentions that "planning CT and HyperSight CBCT image sets, contours, and clinical planning objectives were provided to Varian," implying these were already established by the contributing institutions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI assistance. This study focused on the equivalence of treatment plans generated from different image sources (conventional CT vs. HyperSight CBCT) by the system (RapidPlan), rather than evaluating human reader performance with or without AI assistance. The "AI" aspect is more embedded in or implied by the "RapidPlan" system's ability to generate plans.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, a standalone study was effectively performed. Varian "created radiation treatment plans for each type of image separately, using a standardized planning approach (RapidPlan) available in the Varian Eclipse treatment planning system." This indicates an algorithm-driven comparison of plans generated from different image inputs, rather than focusing on human interaction with the device for performance improvement.

7. The type of ground truth used:

• The ground truth primarily consisted of:
  • Clinical Planning Objectives: These were established by the contributing institutions, including target coverage goals and normal tissue constraints.
  • Contours: Provided for each case, likely drawn by clinicians at the institutions, representing the anatomical structures for planning.
  • Conventional CT Images: These served as a "gold standard" or reference against which the HyperSight CBCT image-based plans were compared for clinical equivalence.
  • Measurements: Ionization chamber measured dose and 2D gamma analysis were used for patient-specific QA, which are objective physical measurements.

8. The sample size for the training set:

• The document does not specify the sample size for the training set. The study described is a clinical validation (test set) for the expanded indication of the already existing device. It focuses on the performance comparison for the intended use, not on the details of the model's training.

9. How the ground truth for the training set was established:

• Not applicable/Not provided in the document. The document describes a study to support a change in the Indications for Use for an existing device, specifically validating the use of HyperSight CBCT images for primary treatment planning. It does not detail how the ground truth for the original training of the Halcyon/Ethos system or its RapidPlan component was established.

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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.

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