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Clarity® is indicated for use in external beam radiation therapy. It provides 3D ultrasound and hybrid imaging of soft tissue anatomy to aid in radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment (Image Guided Radiation Therapy).

When configured with an autoscan probe kit for transperineal ultrasound (TPUS) imaging, Clarity® may be used to continuously track and monitor the prostate and to accurately and precisely guide patient positioning during the delivery of treatment (Intrafractional Position Tracking and Monitoring).

When configured with a gating option, Clarity® may also interface with radiation delivery systems equipped with a compatible external gating control device. With this option, while in tracking and monitoring mode, Clarity® can signal the radiation delivery system to automatically impose a beam-hold when the tracked anatomy has exceeded pre-defined monitoring (tracking) limits, and signal again to release the tracked anatomy returns to a position within those limits (Exception gating has been shown to be compatible with radiation delivery systems equipped with Elekta's Response™ Gating Control System.

The Clarity® system integrates medical diagnostic ultrasound, real-time optical position tracking and proprietary software to acquire and reconstruct 3D images of soft-tissue anatomy for use in external beam radiation therapy. Clarity® offers a non-invasive, non-ionizing means for accurate and precise localization of anatomical structures and patient positioning relative to the treatment isocenter.

The Clarity® system (Model 310C00) is configured around a mobile image acquisition station with an integrated ultrasound scanner, high-resolution touch screen, and high-performance computer system running the Clarity® software. It may be used at the patient's side in the CT-Sim room (Clarity® Sim) and the treatment room (Clarity® Guide) when equipped with a ceiling-mounted optical tracking system, patient/couch position tracking tools and, optionally, remote control and treatment monitoring equipment. With the gating option, the Clarity® Guide acquisition station may interface with radiation delivery systems equipped with a compatible external gating control device.

Each acquisition station is configured with up to three optically-tracked ultrasound probes: one or two hand-held probes for manual scanning and a motorized (autoscan) probe for automated scanning. The user can select the probe and scanning method that is most appropriate for the target anatomy and the patient's clinical presentation. The autoscan probe remains in contact with the patient for continuous imaging of the prostate and surrounding anatomy using specifically designed positioning apparatus for transperineal ultrasound (TPUS); it is operated from the acquisition station's remote control and monitoring equipment interface (touch-screen identical to that on the mobile acquisition station).

A multimodality imaging phantom is used to calibrate Clarity® to the room coordinate system and to verify system integrity for sub-millimeter target localization accuracy and precision within each room (daily and monthly QC).

A dedicated high-performance server and workstation computer system running the Clarity® software is connected to Clarity® acquisition stations through the hospital's local area network. The server houses the central database and web server, and provides for interoperability with other imaging and treatment planning/simulation systems via the DICOM 3/RT protocol. The workstation is used for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, setup of monitoring parameters, and review of treatment and QC data. Optionally, additional Clarity® workstations may be connected to the central Clarity® server.

The Clarity® software is designed to step the user through a radiation therapy workflow or "course" and QC procedures. Different courses are defined to help classify patients in the database and to present the user with reminders, default choices and configuration settings tailored to the target anatomy (e.g., prostate, bladder, liver, uterus & cervix, breast, head & neck). Such configurations include probe type, imaging (scan) presets, contouring and assisted segmentation tools, alert values for target misalignment, and prostate monitoring (tracking) parameters.

The typical use of the system for a radiation therapy course begins with the acquisition of a baseline 3D ultrasound (3DUS) scan with the patient in the planning position. The planning CT is imported, registered and fused with the 3DUS on the Clarity® workstation to verify the alignment of the target anatomy. The structures of interest are then defined and a baseline positioning reference including, if applicable, monitoring (prostate tracking) parameters are approved. Optionally, the 3DUS and related contours may be exported via DICOM to a third-party virtual simulator or treatment planning system.

To assist with patient positioning prior to each treatment session, a new 3DUS scan is acquired and used to determine target displacement relative to the baseline planning-day position. Optical tracking of couch position allows for accurate and precise patient repositioning relative to the treatment isocenter (Image Guided Radiation Therapy).

Automatic image analysis identifies a soft-tissue structure such as the prostate in successive transperineal 3DUS images, which are acquired continuously during treatment, and allows Clarity® to track its motion and assist with patient repositioning (Intrafractional Position Tracking and Monitoring). When configured with the gating option, while in tracking and monitoring mode, Clarity® can signal the radiation delivery system to automatically impose a beam-hold when the tracked structure position has exceeded pre-defined monitoring (tracking) limits, and signal again to release the beam-hold when the structure returns to a position within those limits (Exception Gating).

Clarity® may optionally be configured to send calculated couch shifts for patient repositioning to the operator at the couch control user interface using the MOSAIQ® Workflow Manager.

A web-based interface is available for remote review and approval of positioning references and other treatment parameters, and review of completed treatment session and QC procedure data.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a quantitative format. Instead, it generally states that the device fulfills its design and risk management requirements and localization accuracy and precision specifications were verified.

However, based on the narrative, we can infer some implied performance expectations:

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

The document does not explicitly state the sample size for a "test set" in terms of patient data. The testing primarily focuses on device verification and validation using phantoms and simulated conditions.

• Sample Size: Not explicitly stated for patient data. The document mentions "multimodality phantoms" for accuracy and precision verification and "simulated treatment conditions" for exception gating validation. It also mentions "representative end-users" for human factors evaluations.
• Data Provenance: Not applicable in the context of patient data for performance claims, as the testing described is primarily focused on phantom studies and simulated use, not clinical performance studies with patient data.

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

This information is not provided. The ground truth for the device's accuracy and precision was established using "multimodality phantoms" and validated against their known properties. For usability, "representative end-users" were involved, but their qualifications are not detailed beyond "end-users."

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the described testing (phantom studies, simulated conditions), a formal adjudication method for a test set of clinical cases is unlikely to have been employed or documented 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

No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned. The device, Clarity®, is presented as an image-guidance 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

Yes, standalone performance was assessed for the core functions of the device.

• Localization Accuracy and Precision: Verified using "multimodality phantoms." This implies testing the device's ability to localize targets against a known physical ground truth independent of human interpretation during the measurement phase.
• Exception Gating: "Validated with Elekta's Response™ Gating Control System under simulated treatment conditions." This suggests the algorithm's ability to trigger beam-holds based on defined limits was tested in an automated, standalone manner.

7. The Type of Ground Truth Used

• Localization Accuracy and Precision: Ground truth was established using multimodality phantoms with known, precise physical properties.
• Exception Gating: Ground truth was established through simulated treatment conditions which would have defined parameters for when a beam-hold should be triggered.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of a machine learning or AI model that requires training data. Clarity® appears to be an image guidance system based on established ultrasound and optical tracking technologies, not a system that relies on a large dataset for machine learning training.

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

Not applicable as no "training set" is mentioned or implied for a machine learning component. The system's functionality is based on physics, engineering, and software development, with calibration and verification against known physical standards.

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The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

The associated Integrity R3.1 software is the interface and control software for the Elekta medical digital linear accelerator and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation.

Both High Dose Rate mode and flattened beams are intended to be used for single or multiple fractions, delivered as static and/or dynamic, in gated or un-gated deliveries, in all areas of the body where such treatment is indicated.

The use of the Agility multileaf collimator in conjunction with an Elekta digital linear accelerator may be helpful in the delivery of radiation for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.

This Traditional 510(k) describes changes to the Elekta range of medical linear accelerators when fitted with the Agility multileaf collimator and associated Integrity linac control system. Items added are; High Dose Rate mode x-rays, specific clinical indications for use, and the Response™ gating interface that enables the linac treatment beam to be automatically turned on and off by signals from an external gating device.

High Dose Rate mode x-rays are provided by changes to the filtering arrangement to reduce wasteful attenuation of the beam.

The Elekta Agility Multileaf Collimator system, including the Agility MLC, Integrity R3.1 software, High Dose Rate mode, and Response™ gating interface, underwent non-clinical performance testing to demonstrate substantial equivalence to predicate devices and conformance to applicable technical design specifications, assuring safety and effectiveness.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

*with validated external gating device which has 510(k) clearance
**other methods are not supported with the RPM interface

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

The document does not explicitly state a specific numerical sample size for a "test set" in the context of patient data or clinical images. The testing described is "non-clinical performance testing" which involved:

• "module, integration and system level verification"
• "regression testing"
• "Validation of the system under clinically representative conditions"
• "Testing has been undertaken on production equivalent systems both at Elekta and at hospital sites."

This suggests testing was performed on a sufficient number of hardware and software configurations to ensure functionality and safety, but not on a specific number of patient cases or images for diagnostic performance.

The data provenance is from non-clinical performance testing performed at Elekta and hospital sites. It is not based on retrospective or prospective patient data for an AI-specific algorithm performance evaluation. It's focused on the physical and software performance of the medical device components.

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

This information is not provided in the document. Given that the testing is non-clinical performance testing of a medical linear accelerator accessory, the concept of "ground truth" as established by medical experts (e.g., radiologists) for image interpretation or diagnosis would not typically apply. Instead, the acceptance criteria relate to physics performance metrics and software functionality, which would be verified against engineering specifications by qualified engineers and physicists. The document mentions "competent and professionally qualified personnel" for validation, but does not specify their number or exact qualifications.

4. Adjudication method for the test set:

This information is not provided and is not applicable in the context of this type of non-clinical device performance testing. Adjudication methods are typically used when multiple experts are interpreting data to establish a consensus ground truth for classification or detection tasks, which is not the nature of the testing 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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks (e.g., radiologists interpreting images with or without AI assistance). The device
(a multileaf collimator and control system for radiation therapy) is not an AI-powered diagnostic tool, but rather a treatment delivery system for which the performance is measured by physical and software parameters, not human reader interpretation.

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

While the device itself is an "algorithm" in the sense of software control, the term "standalone" in this context usually refers to an AI algorithm processing data (e.g., images) independently of human intervention for diagnostic or analytical purposes. This device is a component of a larger system (radiation therapy) where human practitioners make clinical decisions.

The document describes comprehensive testing of the device's components and integrated system to ensure they meet performance specifications. This is "standalone" in the sense that the device performs its functions as designed, but it's not an AI performing an independent diagnostic task. The validation focused on the technical performance of radiation delivery and control.

7. The type of ground truth used:

The "ground truth" for the non-clinical performance testing described would be the engineering design specifications and recognized international standards (e.g., IEC 60601-1, IEC 60601-2-1, IEC 62366, ISO 14971). The device's measured physics performance (e.g., transmission, leakage, dose rates) and software functionality were compared against these predetermined, quantitative criteria.

8. The sample size for the training set:

Not applicable. The device is not an AI algorithm that learns from a training set of data. It's a hardware and software system designed and programmed to perform specific functions.

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

Not applicable. As stated above, there is no "training set" in the context of AI model development for this traditional medical device submission. The device's functionality is based on engineering design and rigorous testing against established specifications and standards.

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Clarity® is indicated for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft-tissue anatomy to support radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment.

Clarity® may also be used with an Autoscan Probe for transperineal ultrasound (TPUS) imaging, to continuously monitor the motion of the prostate and to accurately guide patient positioning during the delivery of treatment (i.e., intra-fractionally).

Clarity® integrates medical diagnostic ultrasound and a real-time optical measurement system, which determines the 3D position of the ultrasound probes, to acquire and reconstruct 3D images of soft-tissue anatomy for use in external beam radiation therapy. During the course of treatment, non-ionizing 3D ultrasound imaging and optical tracking of couch position with Clarity® offers a noninvasive means for accurate localization of anatomical structures and patient positioning.

Clarity® comprises the following functional components:

• The Clarity® Acquisition Station is configured around an ultrasound console, which may be suspended from an articulated arm or mounted on a cart, with an integrated computer system and high-resolution touch screen. Acquisition stations are placed in the CT-Sim room (Clority® Sim) and the treatment room (Clority® Guide), with a celling-mounted optical measurement system and patient/couch position tracking tools.
• Each acquisition station is equipped with optically-tracked ultrasound probes; one or two hand-held probes for manual scanning and a motorized (Autoscan) probe for automated scanning. The user can select the probe and scanning method that is most appropriate for the given target anatomy and the patient's clinical presentation. The Autoscan probe includes a positioning apparatus that is specifically designed for transperineal imaging. The Autoscan probe remains in place during a CT-Sim scan and during radiation treatment; scanning is controlled from a remote console interface.
• A multimodality phantom is used for image calibration to the room's coordinate system that is defined by the corresponding room lasers, and for daily verification of system integrity for sub-millimeter target localization accuracy within each room.
• One or more dedicated workstation computer systems, connected to the hospital's local area network, are used for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, and review of treatment sessions.
• A dedicated central server computer system (typically combined with a workstation) houses the patient database and provides for interoperability with other imaging and treatment planning/simulation systems using the DICOM 3/RT protocol.

The Clarity® software is designed to step the user through a radiation therapy workflow or "course." Different courses are defined (e.g., "Prostate", "General", "QC") to help classify patients in the database and to present the user with default choices and settings, tailored for the target anatomy (e.g., prostate, bladder, liver, uterus & cervix, breast, head & neck) and daily QC. Such configurations include probe type, scan settings, contouring and assisted segmentation tools, and alert values for target misalignments.

At the time of CT-Simulation, a 3D ultrasound (3DUS) scan is acquired with the patient in the planning position. At the Workstation, the planning CT is imported and fused with the 3DUS, the structure of interest is defined, and a baseline positioning reference is approved. The 3DUS may be exported via DICOM to a third-party virtual simulator or treatment planning system (TPS),

In the treatment room, a 3DUS scan is used to determine target displacement relative to the baseline planning-day position, and to guide patient positioning prior to treatment.

When used with the Autoscan probe, Clarity® allows for continuous imaging of the prostate and surrounding anatomy to enable precise motion management during the delivery of treatment (i.e., intra-fractionally).

To assist with the clinical workflow, Clarity® can be configured to send calculated couch shifts to the operator at the couch control user interface.

A web-based software interface is available with Clarity® for remote review of treatment session data and positioning references.

Given the provided text, the device in question is Clarity®, a patient positioning system for ultrasound, indicated for use in external beam radiation therapy, and specifically for continuous monitoring of prostate motion during treatment with an Autoscan Probe.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

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

The document does not explicitly state quantitative acceptance criteria in a clear, tabulated format. However, it mentions qualitative statements about performance and verification.

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: The document mentions "actual patients" for the prostate motion tracking study, but does not specify the number of patients or the sample size.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not explicitly stated, but the description "continuous monitoring sessions with actual patients under simulated treatment conditions" suggests a prospective observational study. The usability study was a "simulated use" study.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.

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

The document does not specify any adjudication method for the test set.

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

The document describes a "side-by-side comparison with the Calypso® 4D Localization System" concerning "clinical performance for prostate motion tracking." This comparison is mentioned as a way to demonstrate the device's performance, but it is not described as an MRMC comparative effectiveness study where human readers improve with AI vs without AI assistance. The Clarity® device itself performs the "automatic image analysis and contouring of soft-tissue structures" to track motion, rather than assisting human readers in a diagnostic or interpretive task where improvement metrics like effect size would be quantified in the manner described.

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

Yes, a standalone performance assessment was done for the algorithm's capability.
The text states: "4D monitoring with Clarity® is based on automatic image analysis and contouring of soft-tissue structures, such as the prostate, in transperineal 3DUS images, which are continuously acquired during treatment. This is an expanded capability over the predicate Clority® OBP System, in that the Clority® software is now able to identify the soft-tissue target and track its motion over successive 3DUS images." This description clearly indicates an algorithm-only function (automatic image analysis and contouring, tracking motion over successive images).

Additionally, "Localization accuracy and precisions have been verified with multimodality phantoms," which would typically be a standalone performance test.

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

The document mentions a "side-by-side comparison with the Calypso® 4D Localization System" for prostate motion tracking. In this context, the Calypso® 4D Localization System (which tracks electromagnetic signals from implanted markers) likely served as the reference or "ground truth" for the prostate motion, against which Clarity's performance was evaluated.

For "localization accuracy and precisions," the ground truth was derived from multimodality phantoms, which have known, precise target locations.

8. The sample size for the training set

The document does not provide any information about the sample size used for a training set. This is not uncommon for 510(k) summaries, which often focus on verification and validation studies rather than detailed development data.

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

The document does not provide any information on how ground truth was established for a training set, as it does not mention a training set.

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The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

The associated Integrity R3.0 software is the interface and control software for the Elekta medical digital linear accelerator and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

This Traditional 510(k) describes the addition of the new Agility multileaf collimator beam limiting device and its associated control software to the Elekta medical linear accelerator. The new device has 160 leaves of 5mm width at isocenter, a fast leaf speed of up to 65 mm/s, low leakage (<0.5%) and is capable of interdigitation within a maximum field size of 40 x 40 cm. Control is by extension to the existing Elekta linear accelerator control system software. Synchronization of the movement of the dynamic leaf guides with individual leaf movements achieves enhanced leaf speed and removes the need for a split field.

The Agility includes dynamic leaf guides, fluorescing ruby leaf markers ('Rubicon') for improved leaf tracking by the optics system, the elimination of backup diaphragms by providing low interleaf leakage, sculpted field defining diaphragms, separate lighting systems for patient plane illumination and movement control using LEDs, and a new control cabinet on which the Integrity user interface and machine control software is executed including a hardware firewall to provide safe network connection.

The provided document is a 510(k) premarket notification for a medical device called "Agility™," a multileaf collimator, and its associated control software, Integrity R3.0. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than a detailed comparative effectiveness study of AI versus human readers or standalone AI performance.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance are not applicable or cannot be extracted from this specific document.

However, I can provide information based on the engineering and performance specifications detailed in the 510(k) summary.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance of the device and its predicate, primarily focusing on mechanical and physics performance characteristics to demonstrate substantial equivalence. The "study" proving the device meets these criteria is described as "module, integration and system level verification," "regression testing," and "validation... under clinically representative conditions."

Table of Acceptance Criteria and Reported Device Performance:

Note: The "Acceptance Criterion" column reflects the performance of the predicate device (MLCi2), as the submission aims to demonstrate substantial equivalence and often improved performance. The acceptance for the new device is typically meeting or exceeding these established benchmarks.

Study Details (as inferable from the document):

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

   • The document does not specify a "test set" in the context of patient data or clinical images for performance testing like an AI algorithm would.
   • Performance testing was conducted on "production equivalent systems both at Elekta and at hospital sites." No specific sample size (e.g., number of machines, number of tests) is provided, nor is the country of origin of the data explicitly stated other than Elekta Limited being based in the UK.
   • The testing described is engineering verification and validation, not a clinical trial with patient data.

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

   • This question is not applicable. The device is a hardware component (multileaf collimator) and its control software. "Ground truth" in the clinical sense (e.g., definitive diagnosis from experts) is not relevant to its performance testing.
   • Validation was performed by "competent and professionally qualified personnel," but their specific number or detailed qualifications (e.g., radiologist with X years of experience) are not provided as it's not a diagnostic AI device.

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

   • This is not applicable. Adjudication methods are used to establish ground truth in clinical studies, particularly for diagnostic devices or AI algorithms. This device's testing involves engineering and physics measurements.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a component of a linear accelerator used for radiation therapy, not a diagnostic AI system that assists human readers.

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

   • This is not applicable in the context of an AI algorithm's standalone performance. The device is hardware with control software. Its "standalone" performance refers to its mechanical and physics capabilities as documented in the table, without direct human intervention in the moment-to-moment leaf movement (which is automated by the software). However, it is explicitly designed to assist a "licensed practitioner" in delivering radiation, meaning it is ultimately human-in-the-loop for treatment planning and oversight.

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

   • The concept of "ground truth" as pathology or outcomes data is not applicable here. The "ground truth" for the device's performance is typically established by:
     • Technical specifications: Design requirements for leaf width, speed, accuracy, leakage, etc.
     • Physics measurements: Using dosimeters, films, or other calibrated instruments to verify radiation beam shaping, dose delivery accuracy, leakage, etc.
     • Mechanical measurements: Calibrated tools to verify physical dimensions, movements, and resolutions.

7. The sample size for the training set:

   • This is not applicable. This device is not an AI algorithm trained on a dataset in the conventional sense. The "control software" is developed through traditional software engineering processes, not machine learning model training.

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

   • This is not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the software's functionality would be its design requirements and specifications, validated through formal verification and validation protocols.

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The Clarity™ OBP System is intended for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft-tissue anatomy to support radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment.

The Clarity™ OBP System integrates medical diagnostic ultrasound and optical position tracking to acquire and reconstruct three-dimensional ultrasound (3DUS) images of soft-tissue anatomy for use in external beam radiation therapy. During the course of radiation therapy, the Clority™ OBP System offers a non-ionizing means for daily localization of target anatomical structures.

The Clarity™ OBP System comprises the following functional components:

• The 3DUS imaging station (typically one in the CT-simulation room and one in the treatment . room}, including the 3DUS console with an integrated computer system and opticallytracked ultrasound probes, patient/couch position tracking tools, and a ceiling-mounted optical tracking system.
• . A multimodality phantom, for 3DUS image calibration to the room's coordinate system defined by the corresponding room lasers, and for daily verification of system integrity.
• . One or more dedicated workstation computer systems for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, and monitoring of treatment progress.
• . A dedicated central server computer system (typically combined with a workstation), which houses the patient database and provides for interoperability with other imaging and treatment planning/simulation systems using the DICOM 3/RT protocol.

All networked Clarity™ OBP System stations are configured to run the same software version. The software interface is designed to 'walk' the user through a sequence of steps (or "course") to acquire 3DUS scans in the planning position, import planning CT data and fuse with 3DUS, define the structure of interest and approve a baseline positioning reference, acquire another 3DUS in the treatment position to determine target displacement relative planning-day position, and adjust patient positioning prior to treatment. The 3DUS data may be exported through DICOM to a third-party virtual simulator or treatment planning system (TPS).

Different courses are defined in the software (e.g., "Prostate", "General", "QC") to help classify patients in the database and to present the user with default choices and settings, tailored for the target anatomy (e.g. prostate, bladder, liver, uterus & cervix, breast, head & neck) and daily QC tasks. Such configurations include probe type, scan settings, contouring and assisted segmentation tools, and alert values for large target misalignments.

The Clarity™ OBP System provides the option for hand-held ultrasound scanning or automated scanning with a motorized probe. The user can select the probe and scanning method that is most appropriate for the given target anatomy and the patient's clinical presentation. The autoscan probe comes with a probe holder apparatus and a remote control console, specifically designed to facilitate transperineal imaging of the prostate and surrounding soft tissues.

The Clarity™ OBP System also includes an optional web-based interface for remote review of treatment session data and positioning reference images.

The provided text does not contain specific acceptance criteria or details of a study with reported device performance metrics in tabular or descriptive form. The document is a 510(k) summary for the Clarity™ OBP System, primarily focusing on its intended use, device description, comparison to predicate devices, and a general statement about verification and validation testing.

Here's what can be extracted based on the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity) are provided in the document. The text only states that "The verification test results demonstrate that this next-generation device fulfills design and risk management requirements, and performs well in accordance with established specifications for its intended use."

2. Sample Size for Test Set and Data Provenance:

The document broadly mentions "clinical settings under conditions of simulated use" for testing but does not specify any sample sizes (e.g., number of patients, number of images) for a test set. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention an MRMC comparative effectiveness study or any effect sizes related to human readers' improvement with or without AI assistance. The Clarity™ OBP System is described as a patient positioning system utilizing 3D ultrasound and optical tracking, not an AI-assisted diagnostic or interpretive tool in the context of human reader performance.

6. Standalone (Algorithm Only) Performance:

The document describes the Clarity™ OBP System as an integrated system involving hardware and software for acquiring and reconstructing 3D ultrasound images to guide patient positioning for radiation therapy. It does not present a standalone algorithm performance study. The system provides tools for image fusion, contouring, and defining positioning references, but the document does not detail an "algorithm only" performance separate from the overall system's function with a human in the loop (the user).

7. Type of Ground Truth Used:

The document mentions "definition of a positioning reference" and "define the structure of interest" as part of the system's function. The "ground truth" implicitly refers to the accurate localization of target anatomical structures for radiation therapy. However, the exact method for establishing this ground truth for validation purposes (e.g., expert consensus based on other imaging modalities like CT, pathology, or direct outcome data) is not explicitly stated.

8. Sample Size for the Training Set:

This information is not provided in the document. The system uses "predefined "courses" tailored for the target anatomy" and "assisted segmentation tools," which implies some form of training data or rules, but no details on size are given.

9. How Ground Truth for the Training Set Was Established:

This information is not provided in the document.

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Integrity™ is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated

This Traditional 510(k) describes enhancements to the integral software performing the graphical interface and machine control functions for the Elekta range of medical digital linear accelerators. Integrity R1.0 employs a new LynxOS operating system that has a proven track record in safety and security to replace RMX. The software introduces Continuously Variable Dose Rate (CVDR), which is an enhancement to standard dose rate for dynamic delivery techniques. This function increases the number of available dose rates which can make treatment delivery more efficient and provide smoother delivery of VMAT prescriptions. The software supports the ability for the MLCi2 leaves to interdigitate, supporting the creation of island fields for X-Ray treatment delivery techniques.

This 510(k) summary (K102200) describes performance for the Elekta Integrity™ R1.0, which is an integrated digital control system and software for Elekta linear accelerators. It is an enhancement to existing software, primarily introducing a new operating system (LynxOS), Continuously Variable Dose Rate (CVDR), and support for MLCi2 leaves to interdigitate.

The document states that "There has been no change made to the underlying technological characteristics of the product from the predicate device." Therefore, the performance acceptance criteria and study details are not presented in the provided document, as a direct comparison and statement of substantial equivalence to the predicate device (Elekta Desktop Pro™ K080585) is the primary method for demonstrating safety and effectiveness.

Because the submission is for an enhancement to control software for a medical linear accelerator and relies on substantial equivalence to a predicate device for safety and effectiveness, the typical types of studies involving patient data, expert readers, and ground truth for disease detection or diagnosis are not applicable in the same way they would be for a diagnostic AI device.

Therefore, the requested information cannot be fully provided based on the given text. However, I can explain why some sections are not applicable to this type of device and what information is provided.

Non-Applicability of Standard AI/Diagnostic Device Study Criteria:

The Elekta Integrity™ R1.0 is a control system software for a medical linear accelerator, not a diagnostic imaging device or an AI algorithm designed to identify or diagnose medical conditions from patient data. Its primary function is to safely and effectively control the delivery of radiation therapy based on a clinician's prescription.

Therefore, many of the typical acceptance criteria and study details requested (e.g., sample sizes for test/training sets, involvement of radiologists, pathology ground truth, MRMC studies) are not relevant to this type of device and would not typically be found in its 510(k) submission. Instead, the focus for such a device is on software validation, safety testing, and demonstrating that the new features do not compromise the safety or effectiveness of the predicate device.

Information Provided in the Document:

1. Table of Acceptance Criteria and Reported Device Performance:

   • Not explicitly provided in the format of a table with specific performance metrics (e.g., sensitivity, specificity, accuracy).
   • The document implies that the acceptance criterion is "substantial equivalence" to the predicate device, Elekta Desktop Pro™ (K080585), "in safety and effectiveness."
   • The reported "performance" is that the "functionality for Integrity™ is equivalent to its predicate device..." and "The fundamental technical characteristics are the same..." This suggests that the device performs its intended control functions as safely and effectively as the predicate.

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

   • Not applicable/Not provided. This device is control software, not a diagnostic tool evaluated on patient data.
   • Testing would involve software validation, functional testing, and potentially clinical use testing (e.g., phantom studies, dose delivery verification) rather than a "test set" of patient data.

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

   • Not applicable/Not provided. No "ground truth" in the diagnostic sense is established for this device. Ground truth for a linear accelerator control system would involve verifying accurate beam delivery, dose calculations, and machine responses, typically performed by medical physicists and engineers.

4. Adjudication method for the test set:

   • Not applicable/Not provided. As there's no diagnostic "test set" requiring expert adjudication.

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/Not done. This is not an AI-powered diagnostic or interpretive device that assists human readers with case assessment.

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

   • Not applicable/Not explicitly stated in a way relevant to diagnostic AI. The software "stands alone" in controlling the machine, but it is supervised and programmed by a human practitioner. The validation would focus on the software's ability to execute commands and control the accelerator accurately.

7. The type of ground truth used:

   • Implied ground truth related to safety and performance specifications. For control software, ground truth would be defined by engineering specifications, physical laws of radiation, and pre-defined safety limits. Verification would involve testing against these specifications, rather than against pathology or patient outcomes.

8. The sample size for the training set:

   • Not applicable/Not provided. This is not a machine learning or AI device that uses a "training set" of data in the typical sense. It is deterministic control software.

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

   • Not applicable/Not provided.

In summary: The provided document is for a software upgrade to a medical linear accelerator control system. The demonstration of safety and effectiveness relies on "substantial equivalence" to a predicate device, focusing on functional equivalence and the impact of software changes on established performance and safety characteristics, rather than diagnostic performance metrics or studies involving patient data evaluated by human readers and AI.

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The Elekta X-Ray Volume Imaging system, XVI, is an electronic imaging device (EID), designed to be used with the Elekta range of medical linear accelerators and intended to be used as part of radiation therapy treatment process, as determined by a licensed medical practitioner.

XVI, is intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement. Symmetry™ is a software option within XVI that can be used to acquire and display volumetric images of sequential phases of the breathing cycle for the evaluation of respiration induced motion, to assist in identification of appropriate target locations within anatomical structures in motion.

This Traditional 510(k) describes modifications made to the XVI kilo-voltage imaging accessory of the Elekta range of digital linear accelerators. The primary reason for these enhancements is to improve the acquisition and utilization of kV images in facilitating the correction of patient position for anatomical changes or movement. The additional features are; Symmetry™ (4D VolumeView™) to evaluate respiration induced motion, 3D shaped region of interest for registration, dual registration for quantitative information regarding both the critical structures and target position, and 3D seed registration of implanted markers. Improvements have also been made to the operator interface, connectivity with other systems through DICOM and in the provision of licensable options to tailor individual features.

The XVI system consists of a kV radiation source mounted onto the linac gantry drum and a kV radiation image detector.

The provided 510(k) summary for the K100115 submission for the Elekta XVI R4.5 describes modifications to an existing device, primarily focusing on enhanced features for image acquisition and utilization in radiation therapy.

No study details, acceptance criteria, or device performance metrics are included in the provided document.

The submission asserts that "The functionality for the XVI R4.5 is equivalent to its predicate device XVI R3.5 as part of the Elekta Synergy (K051932) in safety and effectiveness. The fundamental technical characteristics are the same as those of the predicate device and differences in operation are described in the comparison chart and discussion provided elsewhere in this 510(k) submission."

This statement indicates that the device was deemed substantially equivalent to its predicate based on the similarity of its technological characteristics and the absence of significant changes that would raise new questions of safety or efficacy. Therefore, a separate study to establish new acceptance criteria or prove performance against them was likely not deemed necessary for this particular 510(k) submission, as the predicate device's performance was relied upon.

To provide the requested information, a detailed review of the original K051932 submission for the predicate device (Elekta Synergy® and its XVI R3.5 component) would be necessary, as that is where the initial performance and safety evaluations would have been established.

Therefore, based solely on the provided K100115 document, I cannot complete the requested tables and information as no such study details are present within this summary.

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The MLCi2 Multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

This Special 510(k) describes modifications to the MLCi multileaf collimator for use as an accessory for the Elekta range of medical digital linear accelerators. These modifications provide the following improvements;

• . Improved x-ray performance (peak and average leakage).
• Improved repeatability of leaf edge position.
• . The ability for leaves to interdigitate.

The provided document is a 510(k) summary for the Elekta MLCi2, a multileaf collimator, and the FDA's clearance letter. This document does not describe a clinical study with acceptance criteria and reported device performance in the manner typically associated with studies assessing diagnostic accuracy or clinical outcomes for AI devices.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (MLCi) for a hardware modification, which is a different type of regulatory submission.

Here's an analysis based on the information provided, highlighting why many of your requested points are not applicable or cannot be answered from this specific document:

1. Table of acceptance criteria and the reported device performance

The document does not present acceptance criteria and reported performance in a table format for clinical efficacy. The "performance" described is in terms of technical improvements over its predecessor, not clinical outcomes.

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

• Not Applicable. This submission is for a hardware modification of a medical device (multileaf collimator) and does not involve a "test set" of patient data in the context of evaluating a diagnostic or AI device's performance. The "test" performed would likely be engineering verification and validation testing to confirm the stated technical improvements and safety.

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

• Not Applicable. As above, there is no "test set" requiring ground truth established by experts in this type of submission. Performance is measured against engineering specifications and comparison to the predicate device's technical capabilities.

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

• Not Applicable. No test set or expert adjudication is 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

• Not Applicable. This is not an AI device, and no MRMC study was performed or described. The MLCi2 is a hardware component for radiation therapy.

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

• Not Applicable. The MLCi2 is a mechanical accessory, not an algorithm.

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

• Not Applicable. No explicit "ground truth" for clinical performance is mentioned. The "truth" in this context refers to engineering specifications met and performance comparable to the predicate device.

8. The sample size for the training set

• Not Applicable. This is not an AI device, and therefore, no training set data is relevant to this submission.

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

• Not Applicable. As above, no training set is relevant.

Study that proves the device meets the acceptance criteria:

The document describes this as a Special 510(k) submission for modifications to an existing device (MLCi to MLCi2). The "study" (or rather, the basis for approval) is the demonstration of substantial equivalence to the predicate device (MLCi, K963624).

The core of the "proof" is that:

• The MLCi2 has fundamental technical characteristics that are the same as the predicate device.
• The modifications (improved x-ray performance/leakage, improved leaf edge position repeatability, ability for leaves to interdigitate, increased leaf height, changed leaf profile/attitude, improved leaf guidance) are described and are considered improvements that do not raise new questions of safety or effectiveness.
• The functionality of the MLCi2 is equivalent to its predicate device. This is typically presented through comparison charts and engineering data (though not detailed in this public summary).

In essence, the study is a technical comparison and verification process, rather than a clinical trial or AI performance study. The FDA's clearance letter confirms their agreement that substantial equivalence has been demonstrated, allowing the device to be marketed.

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Desktop Pro™ is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

This Traditional 510(k) describes enhancements to the integral software performing the graphical interface and machine control functions for the range of medical digital linear accelerators. These enhancements enable existing control functions to be continuously varied during the delivery of radiation therapy. Thus gantry rotation and speed of rotation, multi-leaf collimator - leaf position and head rotation, back-up diaphragms and dose rate can be continuously and simultaneously varied during treatment delivery. The suffix (VMAT) is used commercially to differentiate this version of the software.

Desktop Pro™ (VMAT) is an integrated digital control system, providing interface and machine control functions for the Elekta range of digital accelerators. It comprises a dedicated control cabinet on which the interface and machine control software is executed.

The provided document is a 510(k) summary for the Elekta Desktop Pro™ (VMAT) device. This document focuses on establishing substantial equivalence to a predicate device for regulatory clearance rather than presenting a study demonstrating performance against specific acceptance criteria in the context of AI/ML device evaluation.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies, is not available within this document. The document primarily describes the device, its intended use, and argues for its substantial equivalence to an existing, legally marketed predicate device (Elekta Synergy® K051932) based on technological characteristics and functional similarity. It does not detail a study designed to quantify and prove the device's performance against predefined acceptance criteria using clinical data.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on feature equivalence rather than performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable, as there's no performance study described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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. This device is a control system for linear accelerators, not an AI-powered diagnostic or assistive tool for human readers in the sense of image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an integral control system for a linear accelerator, not a standalone algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in that context.
9. How the ground truth for the training set was established: Not applicable.

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The Elekta Beam Modulator is an X-ray collimator, designed to be used in a linear accelerators and intended to assist a licensed practitioner in the delivery of radiation to defined treatment volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fraction delivery of radiation in all areas of the body where such treatment is indicated.

The Beam Modulator™ is an enhancement to the previously reported MLC, D.C. Number K904124, and the MLCi, multileaf collimator, D.C. Number K980024. The primary intention of this product is to provide more precise conformance to desired treatment volume by providing a leaf pitch of 4 millimetres.

The provided document is a Summary of Safety & Effectiveness for the Elekta Beam Modulator™ and an FDA 510(k) clearance letter. It does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the format typically expected for AI/software device performance.

Instead, the document focuses on regulatory compliance, substantial equivalence to predicate devices, and general safety assurances in the context of a physical medical device (a multileaf collimator for radiation therapy).

Therefore, I cannot extract the requested information as it is not present in the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance (in terms of specific metrics like accuracy, sensitivity, specificity, etc., which would be relevant for software/AI).
• Sample sizes for test sets, data provenance, or expert qualifications.
• Adjudication methods.
• Multi-reader multi-case comparative effectiveness studies.
• Standalone performance studies.
• Types of ground truth.
• Training set sample size or how its ground truth was established.

Summary of what the document does state regarding safety and effectiveness:

• Device Type: The Beam Modulator™ is an enhancement to previously reported MLCs (Multileaf Collimators) and is a physical component of a radiation therapy system.
• Predicate Devices: K904124 (MLCi), K990085 (Varian Millennium MLC), and K030609 (Tarritom Moduleaf). The document states these have an "established and proven track record for safety."
• Purpose: To provide more precise conformance to desired treatment volume by offering a leaf pitch of 4 millimetres.
• Safety & Effectiveness Rationale:
  • Does not raise additional types of safety or effectiveness considerations compared to predicate devices.
  • Considered an "enhancement" to previously cleared Elekta devices.
  • User documents provide comprehensive information for safe and effective use.
  • Compliance testing to IEC 60601-1 and IEC 60601-2-1.
  • Designed to bear the CE mark (European compliance).
  • Developed under an ISO 9001, ISO 13485, and MDD 93/42/EEC Annex II compliant Quality Management System (QMS).
  • Hazard analysis concluded no new safety/effectiveness hazards.
  • Level of concern for the device is "Major" as per FDA guidance for devices containing software (though the document doesn't detail what "software" is involved or its function).
• Intended Use (from FDA letter): Used in linear accelerators to assist licensed practitioners in delivering radiation to defined treatment volumes (e.g., tumors) while sparing normal tissue. Intended for single fraction or multi-fraction delivery in all body areas.

In conclusion, this document is a regulatory submission for a physical medical device enhancement based on substantial equivalence and compliance with established safety standards, not a performance study for an AI or software-driven diagnostic or prognostic device.

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