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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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Ethos Treatment Management is indicated for use in managing and monitoring radiation therapy treatment plans and sessions.

Ethos Treatment Planning is indicated for use in generating and modifying radiation therapy treatment plans.

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.

Ethos Treatment Management is software designed for radiation therapy medical professionals to support them in managing radiation treatments for patients.

Ethos Treatment Planning is software that is designed generate treatment plans, modify treatment plans, and guide users within adaptive treatment sessions.

Halcyon and Ethos Radiotherapy System are single energy linacs designed to deliver Image Guided Radiation Therapy and radiosurgery, using Intensity Modulated and Volumetric Modulated Arc Therapy techniques. They consist of an accelerator and patient support within a radiation shielded treatment room and a control console outside the treatment room.

I am sorry, but the provided text does not contain the specific information required to answer your request regarding acceptance criteria and a study proving device performance. The document describes a premarket notification for several medical devices and confirms their substantial equivalence to predicate devices, but it does not detail specific performance metrics, clinical studies, or acceptance criteria with reported device performance against those criteria.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Whether an MRMC comparative effectiveness study was done or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document mentions that "Hardware and software verification and validation testing was conducted" and "Test results showed conformance to applicable requirements specifications," but it does not provide the details of these tests or their results against specific criteria. It also states, "No animal studies or clinical tests have been included in this pre-market submission," which indicates that the information you requested about clinical performance studies is not present in this document.

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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.

The provided text does not contain information about acceptance criteria for a device's performance that would require a study to prove it meets those criteria.

Instead, the document is a 510(k) premarket notification for a medical device called "Halcyon," a medical charged-particle radiation therapy system. The FDA's letter (pages 0-1) confirms that the device is substantially equivalent to legally marketed predicate devices.

The "510(k) Summary" (pages 3-4) describes the device, its intended use, indications for use, and differences from a predicate device (Halcyon K170817), as well as non-clinical testing and standards conformance.

Key takeaways from the document regarding testing and validation are:

• Non-clinical testing (hardware and software verification and validation) (page 4) was conducted according to:
  • FDA Quality System Regulation (21 CFR §820)
  • ISO 13485 Quality Management System standard
  • ISO 14971 Risk Management Standard
  • Other FDA recognized consensus standards (e.g., IEC 60601 series, IEC 62304, ISO 10993-1, etc.).
• Software was considered a "major" level of concern, and verification/validation testing was conducted as per FDA guidance.
• Electrical safety and EMC testing was conducted, complying with IEC 60601-1 and IEC 60601-1-2 standards.
• The outcome of non-clinical testing was that the product conformed to defined user needs and intended uses, with no remaining discrepancy reports of "Safety Intolerable" or "Customer Intolerable" priority.
• The manufacturer concludes that Halcyon is safe and effective and performs at least as well as the predicate device.

None of the requested information (acceptance criteria table, sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance, training set size, etc.) can be extracted from the provided text. The document focuses on regulatory compliance, safety, and substantial equivalence rather than performance metrics from a specific comparative study.

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The device is a general-purpose ultrasonic imstrument intended for use by a qualified clinician for evaluation of Fetal/OB, Abdominal (GYN & Urology), Pediatric, Small Organ (breast, testes, thyroid), Cardiac (Adult & Pediatric), Peripheral Vascular, Vascular Access, Musculo-skeletal Conventional & Superficial.

The Site -Rite Halcyon device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart.The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, or a combination of these modes. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery in the docking station , the Site~Rite Halcyon is used primarily where portability, size and convenience are essential.

The provided text does not contain detailed acceptance criteria for a diagnostic ultrasound system's performance, nor does it describe a study specifically designed to prove the device meets such criteria. Instead, it is an FDA 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics against specific acceptance criteria.

The document states that "No clinical testing was required" [7]. This means that the submission does not include data from a clinical trial demonstrating the device's performance in a real-world setting against specific clinical endpoints or acceptance criteria.

While the document lists various safety standards the device complies with (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD3: 2004, ISO 10993-1) [8], these are general safety and performance standards for medical electrical equipment and ultrasound devices, not specific performance acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc., that would typically be evaluated in a clinical study.

Therefore, many of the requested details cannot be extracted from this document, as they are not present in a 510(k) summary that did not require clinical testing.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

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

This information is not provided in the document. The document lists general device specifications and modes of operation but does not specify quantitative acceptance criteria for diagnostic accuracy or image quality, nor does it present device performance against such criteria. The "Comparison to Predicate Device" table [8] lists features and controls, showing they are "Same" as the predicate, but this is not a performance comparison against acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as no clinical testing was required for this 510(k) submission [7].

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 as no clinical testing was required [7].

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as no clinical testing was required [7].

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done, as explicitly stated: "No clinical testing was required" [7]. The device is a diagnostic ultrasound system, not an AI software, and the document makes no mention of AI assistance.

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

This concept is not applicable as the device is a diagnostic ultrasound system operated by a clinician, not an algorithm, and no standalone performance study was mentioned [7].

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided as no clinical testing was required [7].

8. The sample size for the training set

This information is not provided as no clinical testing was required [7]. The device is not described as an AI/ML algorithm that would typically have a "training set."

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

This information is not provided as no clinical testing was required [7].

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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:

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.

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