Search Results

The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy stereotactic body radiotherapy (SBRT), or stereotactic radiosurgery (SRS) to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. The megavoltage x-ray radiation is delivered using rotational, intensitymodulated (IMRT), or non-modulated (non-INRT/three-dimensional conformal) treatment techniques and using imageguided (IGRT) or non-image-guided workflows in accordance with the physician-approved plan. The Radixact Treatment Delivery System integrates Surface Guided Radiation Therapy (SGRT) for patient position and motion monitoring, and breath-hold gating.

The predicate and modified Radixact Treatment Delivery Systems are radiation therapy delivery systems, that provide megavoltage CT imaging capabilities coupled with x-ray radiation delivery. The system achieves delivery using rotational, intensity modulated (IMRT), or non-modulated (non-IMRT/three-dimensional conformal) radiation therapy treatment techniques utilizing image-guided (IGRT) or non-image-guided workflows, to tumors or other targeted tissues anywhere in the body, in accordance with the physician-approved plan.

The additional feature update: VitalHold incorporates an external optical monitoring system (EMS), which is integrated with the Radixact system to enable Surface Guided Radiotherapy (SGRT) for patient setup, patient position and motion monitoring, and breath-hold gating.

Neither the predicate Radixact Treatment Delivery System nor the modified Radixact Treatment Delivery System diagnose disease or quantify treatment effectiveness. Accordingly, they are not intended for diagnostic use.

The provided text describes a 510(k) premarket notification for the Radixact Treatment Delivery System, which is a medical device for radiation therapy. The submission focuses on the substantial equivalence of the modified device to a legally marketed predicate device.

It's crucial to understand that this document does not describe a study involving AI-driven diagnostic or treatment planning software that requires complex acceptance criteria based on human expert review, high-volume datasets, or MRMC studies. Instead, it describes a hardware and software update to an existing radiation therapy delivery system, primarily the integration of a Surface Guided Radiotherapy (SGRT) system for patient positioning and motion monitoring, and breath-hold gating.

Therefore, many of the requested elements regarding acceptance criteria for AI performance (like sensitivity, specificity, MRMC studies, large training/test sets for AI, expert readers for ground truth, and adjudication methods) are not applicable to this type of device submission as described in the provided text.

The "Performance Data" section primarily addresses engineering verification and validation, compliance with electrical safety and EMC standards, and risk management. The "Non-Clinical Data" section focuses on testing the functionality of the SGRT integration with the core Radixact system, not AI performance. It states "No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device."

Here's a breakdown of the requested information based on the provided text, indicating where information is present and where it is not applicable or not detailed for this type of device:

Acceptance Criteria and Study for Radixact Treatment Delivery System (K223159)

This submission is for a modification to an existing radiation therapy delivery system, primarily focusing on the integration of a Surface Guided Radiotherapy (SGRT) system for patient positioning and motion monitoring, and breath-hold gating. The "study" described is primarily engineering verification and validation testing to demonstrate the device's functionality, safety, and effectiveness, not a clinical trial or an AI performance study as typically understood for diagnostic support systems.

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

The document lists "Key system performance attributes" related to the SGRT integration and states that "The Verification results show that the design goals and objectives had been met." However, it does not provide a quantitative table of specific acceptance criteria values and reported performance values beyond stating that the tests demonstrated conformity to design specifications and met user needs. The performance attributes mentioned are functional:

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

• Test Set Sample Size: Not specified in terms of patient cases or images for performance testing. The "Non-Clinical Data" section refers to "testing outlined above" (functional tests with a "moving surrogate"), which are likely engineering tests rather than patient studies.
• Data Provenance: Not applicable in the context of patient data for a test set. The validation is primarily technical/engineering.

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

• Not Applicable. This submission does not involve AI-driven diagnosis or analysis requiring expert interpretation of medical images to establish ground truth for a test set. The "ground truth" for the functional tests would be the controlled movement of the surrogate and the expected system response, not expert consensus on clinical data.

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

• Not Applicable. There are no medical image interpretations requiring adjudication for this device's submission as described.

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

• No Multi-Reader Multi-Case (MRMC) study was done. The document explicitly states: "No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device." This device is a treatment delivery system, not a diagnostic AI system intended to assist human readers in interpretation.

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

• The performance evaluation focused on the integrated system's functional capabilities (tracking, beam delivery, pausing, informing user). While the SGRT system itself performs some automated actions (e.g., gating the beam), the evaluation is of its function within the treatment delivery workflow, not as a standalone AI algorithm producing outputs for human review. The document does not describe "algorithm only" performance as a separate study element in the context of an AI-driven system.

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

• Type of Ground Truth: For the "Key system performance attributes" related to the SGRT, the ground truth would be the controlled and known physical parameters of the moving surrogate (e.g., its position, movement beyond/within thresholds) and the expected system response according to design specifications. This is typical for engineering verification and validation of a mechanical/software system, not clinical ground truth from patient data like pathology or expert consensus.

8. The sample size for the training set

• Not Applicable. This document does not describe the development of a machine learning (AI) model with a "training set" in the context of diagnostic or predictive AI. The submission is for a hardware and software update to a radiation therapy delivery system.

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

• Not Applicable. As there is no described training set for an AI model, this question is not relevant to the provided text.

Ask a specific question about this device

The Accuray Precision® Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

The Accuray Precision® Treatment Planning System is a radiation therapy planning system used for the creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.

The radiation treatment plan is developed by using diagnostic CT (primary image series) and/or secondary images (MR and PET) of the patient previously acquired prior to treatment and saved into the central database server (iDMS Data Management System). The images are imported from the database server into the Accuray Precision® Treatment Planning System to register/ fuse for dose calculation, and to accurately define/contour regions of interest (target) and the surrounding critical anatomical structures to avoid.

The user (dosimetrist/ medical physician) then specifies the treatment delivery machine (CyberKnife or TomoTherapy systems, Radixact systems), treatment delivery mode (e.g., 3DCRT, IMRT) and the patient alignment at the treatment machine. This is followed by specifying the radiation dose criteria for the identified regions of interest, as well as the number of fractions over which this dose is to be administered. After the relevant data has been entered, the user initiates the treatment plan calculation or optimization process. When the treatment plan has been calculated, the user may refine the plan with adjustments to the regions of interest, avoidance structures, and dose criteria and re-optimize the plan.

Once an optimized treatment plan is produced that meets the requirements of the intended therapy, the prescribing physician approves the plan for delivery and the plan is saved on the database server as a treatment delivery plan. The plan reports are also printed for the patient record.

The provided text describes a 510(k) submission for the Accuray Precision® Treatment Planning System. It states that the subject device, with modifications, is substantially equivalent to its predicate device. However, the document does not contain the specific details regarding acceptance criteria, reported device performance in a table, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance data for an AI/ML component.

The document only generally mentions:

• "Software verification and validation was conducted, and documentation is provided as recommended by FDA's Guidance for Industry and FDA staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'."
• "The results from testing included in the premarket notification demonstrate that the performance characteristics of the subject device are substantial equivalent to the predicate device."
• "The performance test data for subject device... confirms that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as compared to the treatment plans created using the predicate device."

Without specific numerical performance data or detailed study descriptions, it's impossible to fill out the requested information. The text indicates that these performance data exist and were submitted to the FDA, but they are not included in this public summary.

Therefore, I cannot provide the requested information from the given text. A typical 510(k) summary (public version) does not usually include the granular details of the V&V studies, especially for features like "dose calculation algorithms" which are mentioned as having "minor enhancements." If these enhancements involved an AI/ML component, the detailed study would be in a separate, non-public section of the submission.

Ask a specific question about this device

The kVCT Imaging Feature is an option within the indications for use of the Radixact Treatment Delivery System. The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

The kVCT Imaging Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The primary functions of the kVCT Imaging Feature are: 1) acquisition of kV x-ray images according to input protocols in concert with other subsystems, 2) correcting 2D images and 3) returning reconstructed 3D images.

The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.

The provided text describes the 510(k) summary for the Accuray kVCT Imaging Feature for the Radixact Treatment Delivery System. However, it does not contain the specific details of acceptance criteria for diagnostic imaging performance or the results of a study proving the device meets these criteria in the way typically found for AI/CADe devices.

Instead, this document focuses on establishing substantial equivalence to a predicate device (Radixact Treatment Delivery System, K161146) and a reference device (Motion Tracking And Compensation Feature For The Radixact Treatment Delivery System, K182687) by comparing technological characteristics and ensuring safety and performance are equivalent or better. It emphasizes that the kVCT imaging offers improved intrinsic tissue contrast and image quality characteristics compared to that of MVCT imaging (from the predicate).

Therefore, I cannot populate the table and answer all questions in the requested format for acceptance criteria and a study proving performance, as that information is not present. The document explicitly states: "No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device."

However, I can extract the comparative performance specifications between the MVCT Imaging (predicate) and kVCT Imaging (subject device), which are presented as characteristics rather than formal acceptance criteria and study results.

Here's the information that can be extracted, acknowledging the limitations mentioned above:

1. A table of (comparative) performance characteristics:

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

• The document explicitly states: "No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device."
• Therefore, there is no test set of clinical images described in this document for evaluating diagnostic imaging performance against acceptance criteria. The data provenance is not applicable in this context.

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

• Not applicable as no clinical test set with ground truth established by experts is mentioned.

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

• Not applicable as no clinical test set is mentioned.

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:

• No MRMC study is mentioned. This device is an imaging feature, not an AI/CADe device designed to assist human readers in interpretation.

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

• The performance data cited ("Results of verification and validation testing confirm that the use of the kVCT Imaging Feature on the Radixact Treatment Delivery System conforms to design specifications and meets the needs of the intended users") refers to the engineering and technical performance of the imaging system itself, such as spatial resolution, image noise, contrast resolution, uniformity, and radiation dose, as shown in the table. These are intrinsic performance characteristics of the imaging modality, not a "standalone algorithm" performance in the context of an AI/CADe device.

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

• For the technical performance characteristics listed (e.g., spatial resolution, image noise), the ground truth is typically established through phantom studies and metrology, comparing measured values against engineering specifications rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set:

• Not applicable as this document does not describe an AI/CADe device that uses a training set of images.

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

• Not applicable.

Ask a specific question about this device

The Motion Tracking and Compensation Feature is an option within the indications for use of the Radixact Treatment Delivery System. The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

The Motion Tracking and Compensation Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The Motion Tracking and Compensation Feature measures tumor location and motion using images provided by a kV imaging subsystem and predicts tumor location based upon a respiration amplitude measurement device. The Radixact Treatment Delivery System then compensates for tumor motion by making real-time adjustments.

The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.

The provided text describes a 510(k) premarket notification for a new feature (Motion Tracking and Compensation Feature) for an existing device (Radixact Treatment Delivery System). The core of the submission is to demonstrate substantial equivalence to the predicate device, not necessarily to provide specific performance metrics against pre-defined acceptance criteria in the way one might for a diagnostic AI device.

Therefore, the response below will focus on what is available in the text regarding "acceptance criteria" (more accurately, the claims of substantial equivalence) and the "study" (the verification and validation testing) that supports these claims, rather than a typical AI performance table.

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

For a substantial equivalence submission, the "acceptance criteria" are typically demonstrating that the new device feature does not raise new questions of safety or effectiveness compared to a predicate device, and performs as well as the predicate for its intended use. The table below summarizes the claims of substantial equivalence for various characteristics.

Ask a specific question about this device

The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

The TomoTherapy Treatment Delivery System with iDMS is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.

The TomoTherapy Treatment Delivery System with iDMS is a modified version of the predicate TomoTherapy Treatment System (last cleared on K121934). The TomoTherapy Treatment Delivery System with iDMS is the same as the predicate device minus the Data Management System and Treatment Planning Station, but substituting the Treatment Delivery Console (TDC) from the Radixact Treatment Delivery System (last cleared on K161146) in place of the predicate Operator Station. The TomoTherapy Treatment Delivery System with iDMS is designed to deliver radiation therapy treatment plans generated on planning systems such as the Accuray Precision™ Treatment Planning System (last cleared on K171086) and stored on data management systems such as the Accuray iDMS™ Integrated Data Management System (last cleared on K161144).

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and explicitly stating what is not mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not present a formal table of acceptance criteria with corresponding performance metrics for the TomoTherapy Treatment Delivery System with iDMS. Instead, it relies on a comparison to a predicate device, asserting "substantial equivalence." The document states that the new device has "imaging and treatment capabilities equivalent to those of the predicate" and "employs the same fundamental scientific principles, and have substantially equivalent intended uses, principles of operation, performance specifications and technological characteristics."

The only specific performance data mentioned is a general statement: "Results of verification and validation testing confirm that the TomoTherapy Treatment Delivery System with iDMS conforms to design specifications and meets the needs of the intended users." It also notes compliance with "applicable FDA recognized consensus safety standards for radiation therapy medical devices."

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No animal or clinical tests were required to establish substantial equivalence with the predicate device." This implies that there was no separate "test set" in the traditional sense involving patients or biological samples to evaluate the device's performance against specific clinical acceptance criteria. The evaluation was primarily based on technical comparisons to a predicate device and engineering verification and validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical or animal tests were performed, there was no "test set" requiring ground truth established by experts in the context of clinical performance. The evaluation was based on engineering and design specifications and a comparison to a previously cleared device. Therefore, this information is not applicable/not provided.

4. Adjudication Method for the Test Set

As no clinical or animal test set was used, an adjudication method for such a set is not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

An MRMC study was not done, as the document explicitly states: "No animal or clinical tests were required to establish substantial equivalence." This type of study would typically involve human readers.

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

The device described is a treatment delivery system, not an algorithm in the AI sense for diagnosis or interpretation. The performance evaluation focused on the physical device's technical specifications and functional equivalence to a predicate device. Therefore, a "standalone algorithm performance" study as typically understood in AI/medical imaging is not applicable/not provided.

7. The Type of Ground Truth Used

The ground truth used for establishing "substantial equivalence" appears to be the design specifications, performance characteristics, and regulatory clearance of the predicate device (TomoTherapy Treatment System (K121934)), along with compliance to relevant consensus safety standards. The new device was deemed substantially equivalent because its technological characteristics, intended use, and fundamental scientific principles were the same as the predicate.

8. The Sample Size for the Training Set

Since no clinical or animal studies were conducted to establish substantial equivalence for this device, there was no training set used in the context of a statistical or machine learning model. The device's "training" would be analogous to its design and manufacturing process, which adheres to established engineering principles and the specifications of the predicate.

9. How the Ground Truth for the Training Set was Established

As there was no training set in the conventional sense, the establishment of "ground truth" for a training set is not applicable/not provided. The device's functionality is based on its design and manufacturing to meet pre-defined engineering and safety standards, which are continuously refined and validated during product development (verification and validation testing).

Summary of the Study and Device Validation:

The validation of the TomoTherapy Treatment Delivery System with iDMS was primarily a non-clinical equivalency study. The core of the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (TomoTherapy Treatment System (K121934)).

The study involved:

• Detailed comparison of technological characteristics: This included comparing system configuration, physical dimensions, environmental parameters, gantry mechanical features, photon beam characteristics, imaging capabilities, laser systems, patient couch, power distribution, operator station, machine control software, data interfaces, and safety features.
• Verification and validation testing: This was internal engineering testing to confirm the device conforms to its own design specifications and meets the needs of intended users. Specific details of these tests (e.g., number of test cases, methodologies) are not given in the 510(k) summary, but it's stated that they confirm conformance.
• Compliance with recognized safety standards: Testing was performed by an independent certified testing laboratory to ensure compliance with applicable FDA recognized consensus safety standards for radiation therapy medical devices.

The conclusion is that the minor differences between the new device and the predicate do not raise different questions of safety or effectiveness, and the performance data (from verification, validation, and standards compliance) demonstrates substantially equivalent safety and performance. This approach eliminated the need for animal or clinical studies to demonstrate substantial equivalence for this particular 510(k) submission.

Ask a specific question about this device

The Accuray Precision™ Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

The Accuray Precision™ Treatment Planning System is intended to be used by physicians, medical physicists, and dosimetrists to generate radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment plans. Plans may be created with the Accuray Precision™ treatment planning system for delivery using Intensity Modulated Radiation Therapy (IMRT) or 3-D Conformal Radiation Therapy (3DCRT) techniques.

The users will be able to create a plan that satisfies established clinical objectives. For stereotactic radiosurgery, the plan will generally involve delivering a tumoricidal dose to target tissue, while minimizing dose to other tissues. For radiation therapy and stereotactic radiotherapy, the plan will generally involve delivering a damaging dose to diseased tissue at a level that allows healthy tissue in the target volume to recover, while also minimizing dose to tissue outside the target volume.

The treatment plan with dose distributions and complete delivered dose value along with the input data will be available through a user display or printed report for user review and evaluation against the treatment prescription and established physics models. The treatment plan will then be saved by the user, approved by the qualified medical practitioner, and subsequently delivered by the treatment delivery system.

The Accuray Precision™ Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.

The radiation treatment plan is developed by using diagnostic CT (primary image series) and/or secondary images (MR and PET) of the patient previously acquired prior to treatment and saved into the central database server (iDMS™) Data Management System). The images are imported from the database server into the Accuray Precision™ System and registered/ fused for dose calculation and to accurately define/contour regions of interest (target) and the surrounding critical anatomical structures to avoid.

The user (dosimetrist/ medical physician) then specifies the treatment delivery machine (CyberKnife® or TomoTherapy® systems), treatment delivery mode (e.g. 3DCRT, IMRT) and the patient alignment at the treatment machine. This is followed by specifying the radiation dose criteria for the identified regions of interest, as well as the number of fractions over which this dose is to be administered. After the relevant data has been entered, the user initiates the treatment plan calculation or optimization process. When the treatment plan has been calculated, the user may refine the plan with adjustments to the regions of interest, avoidance structures, and dose criteria and re-optimize the plan.

Once an optimized treatment plan is produced that meets the requirements of the intended therapy, the prescribing physician approves the plan for delivery and the plan is saved on the database server as a treatment delivery plan. The plan reports are also printed for the patient record.

This document describes the Accuray Precision™ Treatment Planning System. It appears to be a 510(k) summary submitted to the FDA. The information provided heavily emphasizes comparison to a previously cleared predicate device rather than detailing extensive standalone performance studies for the modified device.

Here's an analysis of the provided text with respect to your questions:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance values in a quantifiable manner typical for assessing diagnostic or prognostic AI/ML devices. Instead, it focuses on demonstrating equivalence to a predicate device.

The "Performance" section states: "The performance test data for subject device, Accuray Precision™ Treatment Planning System with modifications, confirms that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as compared to the treatment plans created using the predicate device... The results from testing included in the premarket notification demonstrate that the performance characteristics of the subject device are equivalent to the predicate device."

The table provided under "Technological Characteristics" compares the subject device to the predicate device, highlighting modifications rather than laying out specific performance metrics.

Implicit Acceptance Criteria (based on the provided text's focus):

• Treatment Plan Quality: "same or higher level of quality as compared to the treatment plans created using the predicate device."
• Equivalence: Performance characteristics are "equivalent to the predicate device."
• Safety and Efficacy: Modifications "do not raise new questions of safety or efficacy and the subject device is as safe and as effective as the predicate device."

Reported Device Performance:

The document broadly states that the performance test data confirms the user can create, save, review, and modify treatment plans with the same or higher quality compared to the predicate device, and that its performance characteristics are equivalent.
Specific quantitative metrics (e.g., dose calculation accuracy within X%, contouring agreement with Y%) are not provided in this summary document. The "Dosimetry Tests" mentioned for the predicate are "Absolute Dose and End-to-End (E2E)" and "Gamma index," and the subject device is stated to have "Same as predicate," implying these tests were used to demonstrate equivalence, but the results are not detailed here.

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

This information is not explicitly provided in the given 510(k) summary. The document mentions "performance test data" but does not specify the sample size of treatment plans or patient cases used for testing, nor the provenance (country, retrospective/prospective nature) of the data.

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 in the given 510(k) summary. Ground truth establishment, if involving expert review, is not detailed. The indication for use states that "Plans must be reviewed and approved by qualified medical practitioners prior to delivery," and the intended use specifies "physicians, medical physicists, and dosimetrists" as users. This implies expert involvement in the clinical workflow, but not necessarily in the validation test set's ground truth creation for regulatory submission.

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

This information is not provided in the given 510(k) summary.

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 type of study is not mentioned in the document. The device is a "Treatment Planning System," which is a tool used by medical professionals, not explicitly an AI-assisted diagnostic or decision-support system in the sense of image interpretation for diagnosis. The study described focuses on the system's ability to generate treatment plans equivalent to a predicate, not on how human readers' performance improves with or without the system's immediate "assistance" in an MRMC setting.

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

The context suggests that the "performance test data" likely evaluated the algorithm's output (treatment plans, dose calculations) in a standalone fashion against expected or established benchmarks (implicitly validated through the predicate device). However, the document doesn't explicitly separate "algorithm only" performance versus system performance with human interaction during the testing phase. The system's purpose is to be used by medical professionals, so "human-in-the-loop" is inherent to its intended use and evaluation. The statement "The user will be able to create, save, review and modify treatment plans..." implies the complete system with user interaction was evaluated.

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

The document does not explicitly state the type of ground truth used for validating the treatment plan quality. For treatment planning systems, ground truth often involves:

• Physics models/calculations: Comparing computed dose distributions against theoretical phantom measurements or highly accurate dose engines.
• Clinical expert review/consensus: Having qualified medical physicists and physicians review the generated plans for clinical acceptability, often against established treatment protocols or expert-generated "ideal" plans.
• Phantom measurements: Physical measurements (e.g., using ion chambers, film, or arrays) within phantoms to verify dose delivery accuracy.

The mention of "Dosimetry Tests" (Absolute Dose, End-to-End, Gamma index) strongly suggests that physical phantom measurements and comparisons against established physics models were a primary component of the ground truth for dose calculation accuracy.

8. The sample size for the training set

This information is not provided in the 510(k) summary. Medical charged-particle radiation therapy systems (and their planning software) typically rely on complex physics models and algorithms, not necessarily on "training sets" in the machine learning sense for their core dose calculation engine, though components might use data-driven approaches. If any such algorithms were used, their training details are not disclosed here.

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

As the sample size and nature of a "training set" are not discussed, the method for establishing its ground truth is also not provided.

Ask a specific question about this device

The CyberKnife® Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The CyberKnife® Treatment Delivery System may be used to treat astrocytoma, glioma, skull base tumors, metastases (brain and bony), nasopharyngeal carcinoma, meningioma, acoustic neuroma, schwannoma, pituitary adenoma, hemangioblastoma, craniopharngioma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, and tumors of the neck, spine, pancreas, liver, lungs, ovary, prostate, and bladder. Patients should be examined by a team of physicians to determine if they are candidates for CyberKnife treatment.

The CyberKnife® Treatment Delivery System (CKTDS), subject of this submission, is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision™ Treatment Planning System (K161136) and iDMS™ Data Management System (K161144).

The CKTDS uses a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem of the treatment delivery system provides X-rays of the treatment area that lets the user know the position of the target. The CyberKnife® Treatment Delivery System uses skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Tracking for dynamic positioning and pointing of the linear accelerator. The fixed aperture, variable aperture, and multileaf collimators are available as various beam-limiting secondary collimators.

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them, as outlined in your request. The document is a 510(k) summary for the CyberKnife® Treatment Delivery System, which primarily focuses on establishing substantial equivalence to a predicate device.

Specifically, it lacks:

• A table of acceptance criteria and reported device performance. While it states "Testing was done to verify that all hardware and software perform as designed" and "The results from testing included in the premarket notification demonstrate that subject device performance characteristics are equivalent to the treatment delivery component of the predicate device," it does not provide specific acceptance criteria or quantitative performance data.
• Sample sizes used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily states that the CyberKnife® Treatment Delivery System is substantially equivalent to the treatment delivery component of the predicate, CyberKnife M6 Systems (cleared under K150873), based on shared intended use, principles of operation, technological characteristics, design, materials, and physical properties. It mentions "regressing testing" was performed to verify existing features, but no details of this testing are provided.

Ask a specific question about this device

The Precision™ treatment planning system is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

The Precision™ Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems. It includes the planning system features of both the currently marketed predicate devices: CyberKnife MultiPlan Treatment Planning System (K150873) and the TomoTherapy Planning Station (K121934). Hence, the Precision Treatment Planning System is intended for treatment planning for multiple platforms:

• · Accuray's robotic radiosurgery systems, including but not limited to the CyberKnife® Treatment Delivery System (last cleared K150873).
• · Accuray's ring gantry systems, including but not limited to the Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System (last cleared K121934).

The provided document is a 510(k) summary for the Accuray Precision™ Treatment Planning System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not explicitly state acceptance criteria or provide a detailed study report that proves the device meets specific performance criteria through quantitative metrics.

The document focuses on demonstrating substantial equivalence to existing predicate devices (CyberKnife MultiPlan Treatment Planning System (K150873) and TomoTherapy Planning Station (K121934)) rather than presenting a standalone performance study against pre-defined acceptance criteria.

Therefore, many of the requested details such as specific acceptance criteria thresholds, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, or MRMC study results are not available in the provided text.

Here's what can be extracted based on the information given, and where information is missing:

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

The document does not provide a table with explicit numerical acceptance criteria. Instead, it states:

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "performance test data" but does not detail its composition.

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)

• Not specified. The document states that "Plans must be reviewed and approved by qualified medical practitioners prior to delivery," implying expert review is part of the clinical workflow, but it doesn't detail their role in establishing ground truth for testing.

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

• Not specified.

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

• No MRMC or comparative effectiveness study involving human readers with and without AI assistance is mentioned. The device is a "Treatment Planning System," not an AI-assisted diagnostic tool for human readers. Its primary output is a treatment plan (dose distribution and parameters), not a diagnostic interpretation.

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

• The document implies that the system's performance was evaluated standalone in comparison to the predicate systems, without explicitly calling it an "algorithm only" study. It states, "The performance test data for Precision Treatment Planning System demonstrates that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as currently produced by each of the individual predicate treatment planning systems." The focus is on the system's ability to generate treatment plans.

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

• Not explicitly stated. Given it's a treatment planning system, the "ground truth" for its performance would likely relate to the accuracy of dose calculations and the ability to generate plans that meet established clinical objectives and physics models, which are typically validated against physical measurements (phantoms) and clinical expert review. The document mentions "review and evaluation against the treatment prescription and established physics models."

8. The sample size for the training set

• The document focuses on the performance of the system as a whole rather than a specific AI component that would require a separate training set. While the system may employ algorithms, the 510(k) summary doesn't detail distinct training sets for machine learning models. Therefore, this information is not provided.

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

• As above, details regarding training sets and their ground truth establishment are not provided in this 510(k) summary.

Ask a specific question about this device

The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.

The Radixact Treatment Delivery System is an updated design of the radiation delivery elements of the predicate TomoTherapy Treatment System (last cleared on K121934). The Radixact Treatment Delivery System delivers radiation therapy treatment plans generated on planning systems such as Accuray's Precision™ Treatment Planning System and stored on Accuray's iDMS™ Integrated Data Management System devices. The planning and data management devices are not addressed in this 510(k).

The Radixact Treatment Delivery System is a prescription device that delivers radiation in accordance with a physician approved plan. As with the TomoTherapy Treatment System, the Radixact Treatment Delivery System does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness. Accordingly, it is not intended for diagnostic use.

This document does not contain an acceptance criteria table or a study description with the requested details. The primary purpose of this document is a 510(k) premarket notification for the Radixact Treatment Delivery System, asserting its substantial equivalence to a predicate device (TomoTherapy Treatment System, K121934).

Here's a breakdown of what is and is not in the provided text, in relation to your request:

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

• Not Found: The document does not present a table of specific quantitative acceptance criteria or detailed reported device performance metrics in the format requested.
• What is present: There is a detailed comparison table (pages 5-6) that highlights "General Characteristics" of the predicate device and the subject device (Radixact Treatment Delivery System). This table focuses on technological characteristics (e.g., dimensions, gantry features, radiation delivery modes, imaging parameters, patient couch motion) and largely states "Identical to predicate" or "Functionally equivalent to predicate" for many parameters, or provides specific values for both devices without explicitly stating "acceptance criteria" or a quantitative "performance result" against a pre-defined threshold.

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

• Not Found: The document states, "No clinical tests were required to establish substantial equivalence" (page 8). Therefore, there is no mention of a test set, its sample size, or data provenance from a clinical study.

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

• Not Found: As no clinical tests were required, there is no information about experts establishing ground truth for a test set.

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

• Not Found: No clinical tests, no adjudication method.

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:

• Not Found: No MRMC study was conducted or mentioned, as the device is a radiation therapy delivery system, not an AI-assisted diagnostic tool for human readers.

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

• Not Found: Not applicable for this type of device. The device itself delivers radiation therapy as directed by a practitioner, it's not an algorithm providing a standalone diagnostic or treatment recommendation.

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

• Not Found: Since no clinical studies were performed for this 510(k), no ground truth establishment is discussed. The device's "performance" is assessed through engineering verification and validation testing against design specifications, conformity to recognized consensus safety standards, and comparison of technological characteristics to the predicate.

8. The sample size for the training set:

• Not Found: This device is a hardware system for radiation delivery, not a machine learning model that would require a "training set" in the conventional sense.

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

• Not Found: Not applicable, as it's not an AI/ML device that uses a training set with ground truth.

In summary:

The provided document is a 510(k) summary focused on demonstrating the substantial equivalence of the Radixact Treatment Delivery System to a predicate device. It relies heavily on comparing technical specifications, intended use, and functioning principles, and states that "No clinical tests were required to establish substantial equivalence" (page 8). Therefore, it does not contain the detailed information about acceptance criteria, clinical study methodology, sample sizes, or ground truth establishment that you've requested, as these were not part of the substantial equivalence pathway for this particular device submission. The performance data mentioned refers to "verification and validation testing confirm[ing] that the Radixact Treatment Delivery System conforms to design specifications and meets the needs of the intended users" (page 8), rather than clinical study results.

Ask a specific question about this device

The iDMST™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.

The subject device, iDMS™ Data Management System, is essentially the CyberKnife® Data Management System (CDMS) cleared in the predicate device, the CyberKnife® Robotic Radiosurgery System. This submission simply establishes the iDMS™ System as a stand-alone data management system and reflects its integration with Accuray's robotic radiosurgery and ring gantry systems, including but not limited to the CyberKnife® System and Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System. As such, modifications are limited to those required to integrate the iDMS™ System with the Radixact™ System which is a next generation TomoTherapy® Treatment System.

The iDMS™ System is a data management system that provides storage, applications and interfaces to access, add, modify, export, delete, and validate patient, user and system data for Accuray's radiotherapy, stereotactic radiotherapy, and stereotactic radiosurgery delivery systems, including but not limited to the CyberKnife® System and Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System, as well as treatment planning systems, including the Precision™ Treatment Planning System. The IDMS™ System can store and retrieve treatment plans and delivery data for multiple systems.

I am sorry, but the provided text does not contain detailed information about the acceptance criteria and study results for the iDMS™ Data Management System. The document is a 510(k) summary for FDA clearance and primarily focuses on establishing substantial equivalence to a predicate device.

While it mentions "Testing was completed to verify that all hardware and software perform as designed, as well as regression testing to verify the integrity of existing features. Testing demonstrated that the iDMS™ System performance is equivalent to the predicate, the CDMS features," it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states that the iDMS™ Data Management System is "essentially the CyberKnife® Data Management System (CDMS) cleared in the predicate device, the CyberKnife® Robotic Radiosurgery System," and that "modifications are limited to those required to integrate the iDMS™ System with the Radixact™ System." This suggests that the system's performance might be considered equivalent to the predicate device without requiring a new, extensive clinical study if the modifications are minor and do not alter fundamental performance characteristics.

Therefore,Based on the provided text, I cannot answer your request.

Ask a specific question about this device