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The MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The MRIdian Linac system is an image-quided radiation therapy (IGRT) system that uses a 6 MV linear accelerator radiotherapy system to deliver ionizing radiation while using a magnetic resonance imaging system for image guidance in real time. The MRIdian consists of the Treatment Planning and Delivery System (TPDS), Magnetic Resonance Imaging System (MRIS) and the Radiation Therapy Delivery System (RDS). These three subsystems are designed to operate concurrently for accurate targeted administration of radiation therapy.

The provided text is a 510(k) summary for the MRIdian Linac System. It outlines the device's technical specifications, intended use, and its comparison to a predicate device to establish substantial equivalence. However, it does not contain acceptance criteria, reported device performance figures, or details of a study (like sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) that would typically be used to prove a device meets specific acceptance criteria related to a new functionality or performance claim.

Instead, this document focuses on demonstrating that the modified MRIdian Linac System is substantially equivalent to its predicate device based on:

• Identical Intended Use and Indications for Use.
• Substantially equivalent technological characteristics, with minor differences that do not raise new questions of safety or effectiveness.
• Conformance to design specifications and satisfaction of intended users' needs, including risk mitigations.
• Compliance with various regulatory and recognized standards (e.g., medical electrical equipment safety, electromagnetic compatibility, software life cycle, usability, biocompatibility).

The document states: "Test results demonstrate that the device conforms to design specifications and meets the needs of the intended users, including assuring risk mitigations were implemented and functioned properly. Software testing was performed and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" This implies that internal verification and validation testing was conducted, but the specific acceptance criteria and the detailed results of these tests are not provided in this public summary.

Therefore, I cannot extract the requested information regarding detailed acceptance criteria and a study proving those criteria are met from the provided text in the format you specified. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with explicit acceptance metrics for a novel AI or diagnostic functionality.

The closest information related to performance that is provided is in the "Summary of Technological Characteristics" table, which compares various physical and imaging parameters of the subject device to the predicate device. This table effectively shows that the characteristics are either "Same" or have minor, non-significant differences (e.g., spatial resolution for volume scans and cine scans).

If this were a submission for a new AI feature, the acceptance criteria would typically involve metrics like sensitivity, specificity, AUC, and the study details would describe how these were measured against a ground truth. None of that is present here.

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The MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere radiation treatment is indicated.

The MRIdian Linac system (K162393; K170751) delivers ionizing radiation using a magnetic resonance imaging system (MRIS) unit for image guidance. This submission describes an optional change only to the treatment planning and delivery imaging workflows of the predicate MRIdian Linac system. ViewRay developed the following additional imaging modalities for use during MRIdian Linac system treatment planning and delivery workflows: 1. Introduction of a Treatment Delivery Computer Unit (TDCU) to increase treatment imaging reconstruction and display speed in excess of eight frames per second along with improved cine image resolution used for target tracking. 2. The predicate MRIdian Linac system supports the import of MR images obtained from a separate imaging system for use in treatment planning. In addition to importing additional MR images, the proposed MRIdian Linac system is also able to generate the following additional MR sequences for use during planning, positioning, and treatment delivery workflows: a. Turbo Spin Echo (TSE) pulse sequence family including Half Fourier Acquisition Single Shot Turbo Spin Echo (HASTE) and Diffusion Prepared Turbo Spin Echo (DP-TSE) which enables the following contrast protocols: i. T1-weighted (spin-lattice; magnetization in the same direction as the static magnetic field); ii. T2-weighted (spin-spin; magnetization transverse to the static magnetic field); and iii. Diffusion-Weighted Imaging (DWI) with ability to generate Apparent Diffusion Coefficient (ADC) maps to overlay and register to other images. b. True Fast Imaging (TRUFI) pulse sequence with radial sampling enabling higher speed imaging during treatment delivery. The currently marketed MRIdian Linac system integrates radiation therapy with simultaneous magnetic resonance imaging of soft tissues to provide optimal alignment, adaptation, and tracking. These proposed changes to the existing system described in this section aim to improve MR imaging speed and quality and provide additional image contrast modalities.

The provided text describes modifications to an existing MRIdian Linac System (K162393; K170751) and seeks to demonstrate substantial equivalence to the predicate device. However, it does not contain explicit acceptance criteria or a detailed study proving the device meets those criteria in the typical sense of a clinical performance study with human readers and ground truth for diagnostic accuracy.

Instead, the document focuses on technical equivalence and verification testing to ensure the new imaging modalities and hardware/software changes do not negatively impact the system's performance and meet safety and quality standards, making it substantially equivalent to the cleared predicate device.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

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

The document provides a "Predicate Device Comparison Chart" (Table 6-1 on page 8) which compares various technical attributes of the cleared device with the device with changes. While these are not framed as "acceptance criteria" in the sense of a clinical performance study (e.g., sensitivity, specificity), they represent the technical performance metrics that were likely considered in verifying equivalence.

2. POSITION
3. TREAT | Same | Maintain existing imaging settings and functionality. | Same |
   | MR Physical Characteristics: Bore Diameter | 700 mm | Same | Maintain physical dimensions. | Same |
   | Spherical Volume (DSV) | 500 mm | (Not specified for "Device with Changes," implied "Same") | Maintain diagnostic spherical volume. | (Implied 500 mm) |
   | MRI Frequency | 14.7 MHz | (Not specified for "Device with Changes," implied "Same") | Maintain MRI frequency. | (Implied 14.7 MHz) |
   | Field Strength | 0.345 T | (Not specified for "Device with Changes," implied "Same") | Maintain field strength. | (Implied 0.345 T) |
   | Field of View | 500 mm | Same | Maintain field of view. | Same |
   | Field Homogeneity |

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The MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

This submission describes a modification to the currently marketed multi-leaf collimator (MLC) cleared as part of the MRIdian Linac system (K162393) intended to enhance beam resolution. The current MLC is comprised of 60 tungsten leaves in two opposing 30-leaf banks. The design modification discussed in this submission essentially divides the two existing leaf banks in half splitting them along the leaf motion direction and shifting the banks by one half of a leaf width. The "tonque and groove" is eliminated from the leaves and the shifted banks act effectively as better focused "tongue and groove" mechanism. As with the predicate, each MLC layer of the modified MLC is focused to a point beyond the source point of the Linac radiation to improve interleaf leakage performance. In this system, the focus point is 15 mm further away than the source point. The minimum projected leaf width then becomes one half the physical projected leaf width. The projected leaf width is 8.3 mm and the projected half leaf width is 4.15 mm. The modified MLC design has two layers of opposing tungsten leaves; the top and bottom layers have 34 and 35 leaves in each bank respectively for a total of 138 leaves. There have been no other changes to the cleared MRIdian Linac system (K162393).

My apologies. I cannot fulfill this request. The provided text is a US FDA 510(k) Premarket Notification document, which primarily focuses on demonstrating substantial equivalence of a modified medical device (MRIdian Linac System with 138-leaf Collimator) to a legally marketed predicate device (MRIdian Linac System with 60-leaf Collimator).

The document does not describe an AI/ML-driven device or study parameters typical for such devices, such as:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC)
• Sample sizes for test sets in the context of AI model evaluation (e.g., number of images, patients)
• Data provenance for AI model training or testing (e.g., retrospective vs. prospective data cohorts, country of origin)
• Expert involvement in establishing ground truth for AI model testing
• Adjudication methods for AI performance evaluation
• MRMC comparative effectiveness studies with AI assistance
• Standalone AI algorithm performance studies
• Ground truth types specific to AI applications (e.g., pathology reports, long-term outcomes)
• Training set details for AI models

Instead, the document focuses on:

• Changes to a hardware component: The modification is to the Multi-Leaf Collimator (MLC), specifically increasing the number of leaves from 60 to 138 to improve beam resolution.
• Engineering and Safety Testing: The "Summary of Performance Testing" section details various IEC and ISO standards for electrical safety, EMC, usability, software lifecycle, and general medical device performance, verifying that the modified hardware system still meets these standards.
• Substantial Equivalence Argument: The core of the 510(k) is to show that despite the MLC change, the device's fundamental functionality and safety remain equivalent to the predicate.

Therefore, I cannot extract the requested information about AI model acceptance criteria and study design from this document because it is about a hardware modification to a radiation therapy system, not an AI/ML medical device.

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The ViewRay (MRIdian) Linac System, with magnetic resonance imaqinq capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The MRIdian Linac system delivers ionizing radiation using a magnetic resonance imaging system (MRIS) unit for image quidance and a 6MV linear accelerator to deliver radiation therapy. The system is designed so that the imaging and radiotherapy fields of view coincide permitting imaging of the patient at the radiotherapy isocenter before and during treatment. The MRIdian Linac system is used with the ViewRay Treatment Planning and Delivery System (TPDS) (K102915). As with the predicate MRIdian System (K111862), the MRIdian Linac System consists of three primary subsystems: The Treatment Planning and Delivery System (TPDS), The Magnetic Resonance Imaging System (MRIS), and The Radiation Therapy Delivery System (RDS). These three subsystems are designed to operate concurrently for accurate targeted administration of radiation therapy.

The provided document is a 510(k) summary for the ViewRay (MRIdian) Linac System (K162393), which is a medical device for radiation therapy. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not necessarily to detail comprehensive acceptance criteria and a study to prove meeting them in the way a clinical trial or performance study for a novel device would.

Based on the provided text, the device itself is a radiation therapy system, not an AI/ML algorithm. Therefore, many of the typical AI/ML-specific questions (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not directly applicable or explicitly stated in this type of regulatory submission for this device. The "performance" being described is primarily related to the physical and functional characteristics of the radiation delivery system.

However, I can extract information related to demonstrating substantial equivalence and the performance characteristics presented.

Here's an interpretation based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document compares the "Device with Change" (K162393, the MRIdian Linac System) to the "Cleared Device" (K111862, the predicate MRIdian System). The "acceptance criteria" can be inferred from the predicate device's performance, as the goal is to show the new device is "substantially equivalent." Where specific quantitative metrics are provided, those can be considered the performance reported for each device.

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

• Sample Size: Not explicitly stated as a number of patients or cases. The "testing" referred to appears to be engineering and physics verification tests on the device itself, rather than studies involving patient data or a "test set" of images/cases in the AI/ML sense. The testing verified conformance to design requirements and safety standards.
• Data Provenance: Not applicable in the context of this device's validation as described (i.e., not a data-driven AI/ML device in the document). The testing is on the physical system's performance.

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

• Not applicable/mentioned. "Ground truth" in this context refers to established engineering/physics standards (e.g., AAPM TG 119) and design specifications, not expert interpretations of medical images for an AI/ML diagnostic or therapeutic algorithm.

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

• Not applicable/mentioned. This refers to consensus methods for expert labeling, which is not relevant for the type of device validation presented here.

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 applicable. The device is a radiation therapy system, not an AI-assisted diagnostic or therapeutic interpretation tool requiring human-in-the-loop performance measurement.

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

• Not applicable as an "algorithm-only" performance in the AI/ML sense. The "standalone" performance is the device's operational characteristics as detailed in the table (e.g., dose accuracy, geometric accuracy). The document states, "Testing executed on the System verified conformance to design requirements and ensured all identified risks and hazards were mitigated, and demonstrated conformance to relevant safety standards. The MRIdian Linac system described in this premarket notification passed all verification testing..."

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

• The "ground truth" for the performance characteristics are established engineering and physics standards, such as:
  • AAPM TG 119 for Static Dose Accuracy.
  • IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC/EN 60601-2-1, IEC/EN 60976, IEC 60601-1-6, IEC 61217, IEC 62083, EN 62304, EN 62366, ISO 10993-1.
  • The design specifications of the ViewRay (MRIdian) System (K111862) serve as the benchmark for substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that uses a "training set" in the conventional sense. The "training" for the device's design implicitly comes from decades of medical linear accelerator and MRI technology development, and experience with the predicate device.

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

• Not applicable. As this is not an AI/ML device with a training set, the concept of establishing ground truth for it is not relevant here.

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The ViewRay System, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The ViewRay™ System for Radiation Therapy is a single medical device that combines a magnetic resonance imaging system for image guidance, with a cobalt-60 radiation delivery system. The system is designed so that the imaging and radiotherapy fields of view coincide, permitting imaging of the patient at the radiotherapy isocenter before and during treatment. These imaging and radiation delivery systems are designed to operate together as the ViewRay System, for accurate, targeted administration of radiation therapy. The ViewRay System is used with the ViewRay Treatment Planning and Delivery System (TPDS) (K102915, FDA clearance 1/12/11).

The magnetic resonance imaging system (MRIS) of the ViewRay System can be used by the clinician to perform three (3) different functions before and during the treatment of a patient. A trained clinician may choose to perform all, some, or none of the functions. These 3 functions are:

• Treatment planning the images from the ViewRay MRIS can be used to perform pre-treatment and on-table planning.
• Patient positioning Fast pilot or planning volumetric images can be used to position the patient.
• Treatment gating (soft tissue tracking)- If the prescribing clinician employs this feature during therapy, planar MR images (in a single plane or in 3 planes) are taken continuously during therapy delivery, to control the beam based on anatomy motion.

The ViewRay radiation delivery system (RDS) consists of:

• Radioactive cobalt-60 sources
• Source shielding heads and movement mechanism
• Gantry and base
• Multi-leaf collimators
• Radiation therapy control system
• User console

The sealed cobalt-60 sources are housed in source-shielding heads made of tungsten alloy and depleted uranium encased with stainless steel. The heads are mounted on a ring gantry located between the gap in the MRIS magnets. The sources can be positioned for therapy (BEAM ON), standby (BEAM HOLD) and shielding (BEAM OFF) by the source movement mechanism. The beams from the sources are shaped to conform to the target using double focused multi-leaf collimators. The radiation therapy interfaces with the radiation treatment planning, imaging, gating, and dose calculation functions by means of the radiation therapy control system (RTCS). This system is the central point of control and is designed to provide fail-safe operation of the ViewRay System. The RTCS includes the Radiation Therapy Controller (RTC) and the Auxiliary Controller (AUXC). The AUXC provides secondary monitoring of the ViewRay System safety functions in the event of an RTC failure. The ViewRay System records patient information, treatment plans, dose administered during each fraction, the accumulated dose, imaging data, and system performance during treatment.

The provided text is a 510(k) Premarket Notification Summary for the ViewRay™ System for Radiation Therapy. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific performance metrics against acceptance criteria in the way a PMA or de novo submission might.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1 (2.0 Edition)
• IEC 60601-2-33 (3.0 Edition)
• IEC 60601-2-11 (2.0 Edition) | Conformed with all applicable sections of IEC 60601-1 (2.0 Edition), IEC 60601-2-33 (3.0 Edition) and IEC 60601-2-11 (2.0 Edition) |
  | Substantial equivalence to predicate device (Trilogy Mx™ Radiotherapy Delivery System K092871) | System performance was found to be equivalent in function to the predicate device. |

Note: The document describes "Design Verification testing" as the study proving the device meets these criteria.

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

• Sample size: Not specified. The document states "Design Verification testing was performed," but does not detail the number of patients, phantoms, or test cases used.
• Data provenance: Not specified. As a 510(k) submission primarily focused on engineering and functional testing, clinical data provenance is not typically detailed in this section unless a specific clinical study for performance was required beyond substantial equivalence.

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.
  • Rationale: This document describes verification testing against design requirements and standards, not a clinical study requiring expert-established ground truth for performance evaluation in the typical sense of diagnostic or prescriptive AI algorithms. The "ground truth" here would be the established engineering specifications and standard requirements.

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

• Adjudication method: Not specified.
  • Rationale: As above, this type of adjudication is typically for clinical performance evaluation (e.g., grading images) and not for engineering verification testing described here.

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

• MRMC study: No, a multi-reader, multi-case comparative effectiveness study was not explicitly mentioned or indicated in the provided text.
• Effect size: Not applicable, as no MRMC study was reported.
  • Rationale: The ViewRay system is a medical device combining imaging and radiation delivery for treatment, not an AI-assisted diagnostic tool for human readers in the way an MRMC study would typically evaluate. The text describes the system's capabilities (e.g., continuous imaging for soft tissue tracking) but not as an "AI assistance" to human readers.

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

• Standalone performance: Yes, the device itself underwent "Design Verification testing" to show conformance to design requirements and standards. This testing evaluates the device's inherent functionality (imaging quality, radiation delivery accuracy, safety features, etc.) as a standalone system. However, it's not an "algorithm-only" standalone performance in the context of an AI device but rather the integrated system's performance. The document focuses on the system's performance against engineering metrics.

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

• Type of ground truth: The "ground truth" for the verification testing described would primarily be:
  • Engineering specifications and design requirements: The device was tested to ensure it met its pre-defined design parameters.
  • Applicable international standards (IEC 60601 series): The device's performance was compared against the requirements set by these medical device standards.
  • Predicate device's established performance: The ViewRay system's function was compared to the Trilogy Mx™ System to demonstrate substantial equivalence, meaning the predicate's performance served as a benchmark for equivalence.

8. The sample size for the training set

• Sample size: Not applicable.
  • Rationale: This document does not describe the development of an "AI algorithm" in the sense that would require a distinct training set for machine learning. The ViewRay system is a complex integrated medical device, and its functional verification does not typically involve training a machine learning model.

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

• Ground truth establishment: Not applicable.
  • Rationale: As there is no mention of a training set for an AI algorithm, the concept of establishing ground truth for such a set is not relevant to this document's content.

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Use of the ViewRay™ Treatment Planning and Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

The ViewRay™ Treatment Planning and Delivery System (TPDS) provides tools for planning and delivery of external gamma beam stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. It is a computer-based device used by trained medical professionals. The Treatment Planning software is only designed to be used on the ViewRay radiation therapy system. The ViewRay TPDS is capable of assisting clinicians in reviewing, prescribing, tracking, and correcting the course of patient treatment using tools for contouring, visualization, data storage, anatomical target monitoring and reoptimization.

The provided text is a 510(k) Summary and related FDA correspondence for the ViewRay™ Treatment Planning and Delivery System. This document focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use and technological characteristics.

Crucially, the provided text DOES NOT contain information about acceptance criteria, the specific studies performed to meet those criteria, device performance metrics, sample sizes for training or testing, ground truth establishment, or any detailed comparative effectiveness studies (MRMC, standalone algorithm performance).

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the given input. The 510(k) summary generally describes the device and claims substantial equivalence, but it does not detail specific validation studies that would include the requested information.

The document indicates:

• Predicate Device: Varian Medical Systems' Trilogy Mx™ System (K092871) and Eclipse™ Treatment Planning System (K091492).
• Intended Use: Planning and delivery of external gamma beam stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
• Technological Characteristics: Similar to the predicate devices with "minor differences."
• Standards Conformance: Designed to conform with applicable sections of IEC 60601-1, IEC 60601-2-11, IEC 62083, and IEC 61217.

To answer your questions, specific validation study reports, which are typically separate from the 510(k) summary, would be required.

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