Search Results

Auto Segmentation generates a Radiotherapy Structure Set (RTSS) DICOM with segmented organs at risk which can be used by dosimetrists, medical physicists, and radiation oncologists as initial contours to accelerate workflow for radiation therapy planning. It is the responsibility of the user to verify the processed output contours and user-defined labels for each organ at risk and correct the contours/labels as needed. Auto Segmentation may be used with images acquired on CT scanners, in adult patients.

Auto Segmentation is a post-processing software designed to automatically generate contours of organ(s) at risk (OARs) from Computed Tomography (CT) images in the form of a DICOM Radiotherapy Structure Set (RTSS) series. The application is intended as a workflow tool for initial segmentation of OARs to streamline the process of organ at risk delineation. The Auto Segmentation is intended to be used by radiotherapy (RT) practitioners after review and editing, if necessary, and confirming the accuracy of the contours for use in radiation therapy planning.

Auto Segmentation uses deep learning algorithms to generate organ at risk contours for the head and neck, thorax, abdomen and pelvis regions from CT images across 40 organ subregion(s). The automatically generated organ at risk contours are networked to predefined DICOM destination(s), such as review workstations supporting RTSS format, for review and editing, as needed.

The organ at risk contours generated with the Auto Segmentation are designed to improve the contouring workflow by automatically creating contours for review by the intended users. The application is compatible with CT DICOM images with single energy acquisition modes and may be used with both GE and non-GE CT scanner acquired images (contrast), in adult patients.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the GE Medical Systems Auto Segmentation device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported device performance (Dice Mean and Lower CI95) for almost all organs meets or exceeds the specified acceptance criteria. The only exception where the device's Dice Mean is slightly below the acceptance criteria is for Mandible (92.70% vs 94.0%) and Oral Cavity (87.43% vs 91.0%) and Pituitary (75.62% vs 78.0%), however there is no further discussion or justification provided in the text for these specific instances. The document does state that "The evaluation of the Dice mean for the Auto Segmentation algorithms demonstrates that the algorithm performance is in line with the performance of the predicate, as well as state of the art, recently cleared similar automated contouring devices."

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

• Sample Size for Test Set: 302 retrospective CT radiation therapy planning exams (generating 2552 contours).
• Data Provenance: Multiple clinical sites in North America, Asia, and Europe. The demographic distribution includes adults (18-89 years old) of various genders and ethnicities from 9 global sources (USA, EU, Asia). The data was acquired using a variety of CT scanners and scanner protocols from different manufacturers.
• Retrospective/Prospective: Retrospective.

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

• Number of Experts: Three (3).
• Qualifications of Experts: Independent, qualified radiotherapy practitioners.
• Comment: The document states that the ground truth annotations were established following RTOG and DAHANCA clinical guidelines.

4. Adjudication Method for the Test Set

• The document implies a consensus-based approach guided by clinical guidelines, as "ground truth annotations were established (...) manually by three independent, qualified radiotherapy practitioners," but it does not specify an explicit adjudication method like "2+1" or "3+1" for resolving disagreements between the three experts. The phrase "established following RTOG and DAHANCA clinical guidelines" suggests that these guidelines were used to define the correct contours.

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

• The document describes a qualitative preference study that involved three qualified radiotherapy practitioners reviewing the contours generated by the Auto Segmentation application. They assessed the adequacy of the generated contours for radiotherapy planning using a Likert scale.
• However, this was NOT a comparative effectiveness study of human readers with and without AI assistance. It was a study to determine the adequacy of the AI-generated contours themselves for initial use. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported from this document.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was conducted. The "Performance testing to evaluate the device's performance in segmenting organs-at-risk was performed using a database of 302 retrospective CT radiation therapy planning exams." The Dice Similarity Coefficient (DSC) was used as the primary metric to compare the Auto Segmentation generated contours to ground truth contours. The reported Dice Mean values and their 95% confidence intervals are direct metrics of the algorithm's standalone performance.

7. Type of Ground Truth Used

• Expert Consensus/Manual Annotation: Ground truth annotations were "established following RTOG and DAHANCA clinical guidelines manually by three independent, qualified radiotherapy practitioners."

8. Sample Size for the Training Set

• 911 different CT exams.

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

• The document states that "The Auto Segmentation algorithms were developed and trained using a dataset of 911 different CT exams from several clinical sites from multiple countries. The original development and training data was used for radiotherapy planning..."
• It does not explicitly detail the process for establishing ground truth for the training set, but given the context of the test set ground truth and the overall development, it is highly probable it involved manual annotation by experts for radiotherapy planning purposes.

Ask a specific question about this device

MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning.

Indication for use:

MRCAT Head and Neck is indicated for radiotherapy treatment planning for patients with soft tissue tumors in the Head and Neck region.

MRCAT Head & Neck is a software application to Ingenia, Ingenia Ambition, and Ingenia Elition MR systems. MRCAT Head & Neck is available to the customer as an option to Ingenia MR-RT package, which is a set of accessories for Ingenia systems.

Automated generation of MRCAT images takes place at the MR console of Ingenia. The embedded image post-processing runs in the background parallel to image acquisition. MRCAT algorithm enables automatic tissue characterization: Bones are segmented from mDixon in-phase and water images using machine learning based segmentation. Body outline is segmented using in-phase and water images. Tissues are then assigned a continuum of HU values depending on the fat and water intensities of the voxels. The HU assignment provides MRCAT images with CT-like density information.

The Philips Oy MRCAT Head & Neck device, a software application for MR systems intended to provide tissue property information for radiation attenuation estimation in photon external beam radiotherapy treatment planning for soft tissue tumors in the Head and Neck region, underwent testing to demonstrate substantial equivalence to its predicate device, MRCAT Brain.

The primary study focused on validating the accuracy of simulated dose calculations and geometric accuracy when using MRCAT Head & Neck images compared to CT-based plans.

1. Table of Acceptance Criteria and Reported Device Performance:

• Simulated dose based on MRCAT Head & Neck images shall not differ in 95% of the indicated patients (gamma analysis criterion 2%/2mm realized in 98% of voxels within the PTV or exceeding 75% of the maximum dose) when compared with CT-based plan.
• The average simulated dose based on MRCAT Head & Neck shall not deviate more than 5% or 1 Gy, whichever is greater, in 99% of the indicated patients in the volume of sensitive organs when compared with a CT-based plan. | - PTV dose differences obtained when using MRCAT in place of CT were well below 1% with a very small bias, indicating clinical insignificance.
• Results for artificial PTVs (automatically placed around the head and neck region) agreed well with clinical plan results, strengthening the conclusion of accurate dose calculations.
• The device met the dose accuracy criteria. |
  | Geometric Accuracy:
• ± 1 mm accuracy: 200 mm diameter sphere
• ± 2 mm accuracy: 400 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane)
• ± 5 mm accuracy: 500 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane) | - The document explicitly states: "MRCAT accuracy:
• ± 1 mm accuracy: 200 mm diameter sphere
• ± 2 mm accuracy: 400 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane)
• ± 5 mm accuracy: 500 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane)"
  While the exact "reported performance" against these metrics is not detailed in the provided summary, the statement "MRCAT Head and Neck met the acceptance criteria and is adequate for this intended use" implies these geometric accuracy criteria were also met. The visibility of bone structures described as "equivalent for both products" (MRCAT Brain and MRCAT Head & Neck) also supports similar geometric performance. |
  | Safety and Effectiveness:
• Compliance with relevant international and FDA-recognized consensus standards (ANSI/AAMI ES60601-1, IEC 60601-1-6, IEC 60601-2-33, IEC 62304, IEC 62366-1, ISO 14971). | - The MRCAT Head and Neck complies with the aforementioned international and FDA-recognized consensus standards. Verified through non-clinical verification and validation tests. The device met the safety and effectiveness criteria. |

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

• Test Set Sample Size: The summary mentions "PTV dose differences obtained when using MRCAT in place of CT" and "artificial PTV analysis". It also refers to "95% of the indicated patients" and "99% of the indicated patients," suggesting a study involving patient data or simulated patient cases. However, the exact number of patients or cases in the test set is not explicitly stated in the provided document.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• The document does not explicitly state the number of experts used to establish ground truth for the test set or their specific qualifications.
• However, it does mention that "The HU values for the MRCAT Head and Neck are calibrated using registered CT images from several sites." This implies that the CT images, which serve as the reference for HU values, were acquired and potentially interpreted by medical professionals, though their role in "ground truth establishment" for the specific test set is not detailed.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method (e.g., 2+1, 3+1). The "ground truth" seems to be primarily based on CT images and their associated dose calculations.

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

• A MRMC comparative effectiveness study was not discussed in the provided text. The evaluation focuses on the device's performance in dose and geometric accuracy against a CT-based plan, rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

• Yes, the study appears to evaluate the standalone performance of the MRCAT Head & Neck algorithm. The dose accuracy and geometric accuracy criteria are stated as direct evaluations of the "simulated dose based on MRCAT Head & Neck images" and "MRCAT accuracy," respectively, implying no human intervention in the generation or initial interpretation of the MRCAT images for these assessments. The device provides "information of tissue properties for radiation attenuation estimation purposes," which is then used in treatment planning.

7. Type of Ground Truth Used:

• The ground truth primarily used for comparing dose accuracy and HU values is based on CT-based plans and registered CT images. CT is considered the gold standard for electron density information in radiotherapy planning.

8. Sample Size for the Training Set:

• The document states that the "CNN is trained using matched pairs of CT and MRCAT source images" and "The HU values for the MRCAT Head and Neck are calibrated using registered CT images from several sites." However, the exact sample size of the training set (number of images/patients) is not specified.

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

• The ground truth for the training set was established using "matched pairs of CT and MRCAT source images." This means that for each MR image used for training the CNN, a corresponding CT image was available. These CT images, presumably acquired as part of standard clinical practice, provided the reference Hounsfield Unit (HU) values for tissue characterization and density information that the MRCAT algorithm aims to replicate. The calibration of HU values also used "registered CT images from several sites," reinforcing the reliance on CT as the ground truth.

Ask a specific question about this device

MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning.

Indications for use:

MRCAT Brain is indicated for radiotherapy treatment planning for primary and metastatic brain tumor patients.

MRCAT brain is a software application to Ingenia, Ingenia Ambition, and Ingenia Elition MR systems. MRCAT brain is available to the customer as an option to Ingenia MR-RT package, which is a set of accessories for Ingenia systems.

Automated generation of MRCAT images takes place at the MR console of Ingenia. The embedded image post-processing runs in the background parallel to image acquisition. MRCAT algorithm enables automatic tissue characterization: Bones are segmented from mDixon in-phase and water images using machine learning based segmentation. Body outline is segmented using in-phase and water images. Tissues are then assigned a continuum of HU values depending on the fat and water intensities of the voxels. The HU assignment provides MRCAT images with CT-like density information.

The document provides information on the Philips Medical Systems MR Finland MRCAT Brain device, which is a software add-on for MR systems intended for radiotherapy treatment planning for primary and metastatic brain tumor patients.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Simulated dose based on MRCAT Brain images shall not differ in 95% of the indicated patients (gamma analysis criterion 2%/2mm realized in 98% of voxels within the PTV or exceeding 75% of the maximum dose) when compared with CT-based plan.
• The average simulated dose based on MRCAT Brain shall not deviate more than 5% or 1 Gy, whichever is greater, in 99% of the indicated patients in the volume of sensitive organs when compared with CT based plan. | The robustness of the MRCAT brain algorithm for producing equivalent dose plans to CT using gamma analysis with criterion of 1%/1mm is shown by post-processing MRCAT images from patients, and calculating dose using the MRCAT images. (Though the reported criterion is 1%/1mm, the acceptance criterion specifically mentioned 2%/2mm, implying the device met or exceeded this with the 1%/1mm demonstration). The document states that MRCAT brain met the acceptance criteria and is adequate for its intended use. |
  | Geometric Accuracy:
• MRCAT accuracy: ± 1 mm accuracy for a 200 mm diameter sphere.
• MRCAT accuracy: ± 5 mm accuracy for a 500 mm diameter sphere (limited in the bore direction by +/- 160 mm from the z=0 mm plane). | The document states "No significant difference" in geometric accuracy when comparing MRCAT Brain to MRCAT Pelvis, which has the same geometric accuracy criteria. It also generally states that "Non Clinical verification and or validation test results demonstrate that the MRCAT brain... Meets the acceptance criteria and is adequate for its intended use." |
  | Compliance with Standards:
• ANSI/AAMI ES60601-1: 2012
• IEC 60601-1-6:2010
• IEC 60601-2-33:2015
• IEC 62304:2016
• IEC 62366-1:2015
• ISO 14971:2007 (A comprehensive list of international and FDA-recognized consensus standards for medical electrical equipment, usability, safety of MR equipment, medical device software lifecycle processes, usability engineering, and risk management). | "The MRCAT brain complies with the following international and FDA-recognized consensus standards." and "Non Clinical verification and or validation test results demonstrate that the MRCAT brain: Complies with the aforementioned international and FDA-recognized consensus standards." |
  | MRCAT image generation correctness:
• Sanity checks to ensure imaging field of view is correctly positioned.
• Sanity checks to ensure MRCAT body outline matches that of the MR. | "The generated MRCAT images are checked for correctness to ensure validity of the generated MRCAT for radiation treatment. The sanity checks ensure that the imaging field of view has been positioned correctly and that the MRCAT body outline matches that of the MR." The overall conclusion on non-clinical tests also states: "met the acceptance criteria and is adequate for this intended use." |
  | HU value calibration:
• The HU values for the MRCAT Brain are calibrated using registered CT images from several sites. | "The HU values for the MRCAT brain are calibrated using registered CT images." and "The overall conclusion on non-clinical tests also states: "met the acceptance criteria and is adequate for this intended use." |

The Study Proving Device Meets Acceptance Criteria:

The document describes a "Summary of Non-Clinical Performance Data" and a "Summary of Clinical Data" to support the device's substantial equivalence and adherence to acceptance criteria.

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

The document mentions that the robustness of the MRCAT brain algorithm for producing equivalent dose plans to CT using gamma analysis was shown by post-processing MRCAT images from patients. However, it does not specify the exact sample size used for this patient data (test set) or the country of origin/provenance (retrospective or prospective) of this patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

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

4. Adjudication Method:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth in the test set.

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

The document makes no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done. The focus is on the device's technical performance in generating comparable dose plans to CT, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance was done. The dose accuracy and geometric accuracy criteria, as well as the comparison to CT-based plans, are direct assessments of the algorithm's performance without human intervention in the primary image generation and initial dose calculation. The "robustness of the MRCAT brain algorithm" and its ability to produce "equivalent dose plans to CT" describe standalone performance.

7. Type of Ground Truth Used:

The primary ground truth used for assessing the device's performance, particularly dose accuracy and HU value calibration, is registered CT images and CT-based treatment plans. The comparisons are made against these CT data, which are considered the established standard for radiation attenuation estimation in radiotherapy planning.

8. Sample Size for the Training Set:

The document states that the Convolutional Neural Network (CNN) used in MRCAT image generation is "trained using matched pairs of CT and MRCAT source images." However, the exact sample size used for the training set is not specified.

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

The ground truth for the training set was established using "matched pairs of CT and MRCAT source images." This implies that CT images served as the reference or ground truth against which the MRCAT source images were processed and the CNN was trained to generate CT-like density information (HU values).

Ask a specific question about this device

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.

Ask a specific question about this device

AdvantageSim™ MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR or PET studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user to define the target or treatment volume over a defined range of the respiratory cycle.

The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.

AdvantageSim™ MD is a CT/MR/PET oncology application used by clinicians (radiologist, radiation oncologist, medical oncologist nuclear medicine physicians and trained healthcare professional) to assist treatment planning.

AdvantageSim MD with MR pelvic organ at risk segmentation Option is used to provide MR based prostate and pelvic organs-at-risk segmentation. A suite of semi-automated MR based organ segmentation contouring allows generating complex structures around organs at risk. These contours overlay on the co-registered CT planning image.

The segmentation methods in the modified device are semi-automatic. The user has to place seed points to identify an inner point of the organ to contour.

The software offers a suite of manual contour editing tools enabling the user to edit, modify, or change contours generated from the MR segmentation tools to their desired configuration based on their medical and clinical knowledge and experience. The results provided by the software needs to be approved by the experienced clinician and can always be modified or corrected by him/her. It is up to the expert user to accept the result without any change, reject it completely and delineate manually, or modify the result and then save it. The software does not provide any auto-detection or auto-saving functionalities.

Same as the predicate devices, the clinician retains the ultimate responsibility for making the pertinent diagnosis and patient management decisions based on their standard practices and visual comparison of the individual images, regardless of the accuracy of the output generated by the software.

Here's an analysis of the provided text to fulfill your request:

Acceptance Criteria and Study for GE Healthcare AdvantageSim™ MD with MR pelvic organ at risk segmentation Option

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific numerical acceptance criteria and performance metrics (e.g., Dice coefficients, Hausdorff distances, specific time savings). The reported performance is generally qualitative or comparative.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "consented clinical images" but does not specify the number of cases.
• Data Provenance: "consented clinical images" - the country of origin is not specified, but the submission is from GE Hungary Kft. The study appears to be retrospective as it uses existing clinical images.

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

• Number of Experts: Three.
• Qualifications of Experts: "board certified Radiation Oncologists who were considered experts."

4. Adjudication Method for the Test Set:

• The document does not explicitly state a formal adjudication method (e.g., 2+1, 3+1). It describes the experts assessing accuracy, precision, and efficiency, and providing qualitative feedback. It implies each expert evaluated the software's performance, but not how disagreements were resolved to establish a single ground truth.

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

• The study described is a usability study that compared the new software against manual methods (implied through efficiency and inter-operator variability assessment). It involved "three board certified Radiation Oncologists". While it involved multiple readers, it is not explicitly labeled as an "MRMC comparative effectiveness study" in the sense of a formal statistical study with defined effect sizes of improvement with AI assistance.
• Effect Size of Human Reader Improvement: Not quantitatively reported. The document states it has "the potential to reduce inter-operator variability" and provides "statistically significant and practically meaningful clinical efficiency improvements," but no numerical effect size is given.

6. Standalone Performance Study:

• Yes, a standalone performance was performed. The device's segmentation methods are described as "semi-automatic" where "the user has to place seed points to identify an inner point of the organ to contour." The software then generates contours. The study assessed the software's output in terms of accuracy, precision, and efficiency, even though a clinician would typically review and edit the results. The clinicians evaluated the device's output and how it facilitated their workflow.

7. Type of Ground Truth Used:

• The ground truth for the test set was established by expert consensus/opinion among the three board-certified Radiation Oncologists. They likely compared the device's segmentations against their clinical knowledge and potentially manual segmentations, though this is not explicitly detailed.

8. Sample Size for the Training Set:

• Not specified. The document does not provide any information about the training data or its size.

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

• Not specified. As the training set size and details are absent, the method for establishing its ground truth is also not mentioned.

Ask a specific question about this device

AdvantageSim™ MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR or PET studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.

AdvantageSim™ MD is a CT/MR/PET oncology application used by clinicians (radiologist, radiation oncologist, medical oncologist, nuclear medicine physicians and trained healthcare professional) to assist treatment planning.

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) Premarket Notification Submission Summary for "GE Healthcare AdvantageSim™ MD with CT Atlas-based Contouring and Re-planning Options." It describes the device, its intended use, and its classification, and notes that the software complies with voluntary standards and underwent quality assurance measures like risk analysis, design reviews, and various testing (integration, performance, safety).

Crucially, under "Summary of Clinical Tests," it explicitly states:

"The subject of this premarket submission, AdvantageSim MD with CT Atlas-based Contouring and Re-planning Options software did not require clinical studies to support substantial equivalence since the two new features have triggered this 510(k) notification, CT atlas-based contouring and CT based re-planning options are part of Mirada’s FDA cleared product."

This indicates that no new clinical study was conducted for this specific 510(k) submission to demonstrate performance against acceptance criteria. Instead, substantial equivalence was established by referencing features already part of an FDA-cleared predicate device (Mirada's product).

Therefore, I cannot provide the requested information from the given text as it explicitly states that clinical studies were not required and thus, no such study demonstrating device performance against acceptance criteria is detailed.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Segasist P-AC contouring software is a standalone software application for Windows platforms that assists clinicians in generating estimates of the anatomy boundary contours of the prostate gland in Computed Tomography (CT) scans, Magnetic Resonance (MR) images and ultrasound (sonography) scans to aid in patient diagnosis, treatment planning and post-treatment monitoring. The software is intended to be used to provide clinicians with tools to efficiently contour/delineate the prostate gland in volume data and save the results in DICOM and BMP format. The clinician has the ability to use the saved contours directly or import them in other software tools to perform the task at hand.

The clinician retains the ultimate responsibility for making the pertinent diagnosis and patient management decisions based on their standard practices and visual comparison of the individual images. The Segasist P-AC software tool is a compliment to manual contouring techniques.

Segasist P-AC (Segmentation Assistant for Prostate – Auto-Contouring) is a standalone atlas-based segmentation software tool for auto-contouring of the prostate gland from different input image modalities (Computed Tomography (CT) scans, Magnetic Resonance (MR) images, ultrasound scans). The software can read, write and display DICOM images from/to local directories, and offers the possibility of defining regions of interest (ROls) around the prostate gland in order to delineate the prostate for contouring, visual assessment, and size and volume calculation purposes, either manually, or via semi-automated or automated processes.

The Segasist P-AC software is a tool that has been designed and developed to assist clinicians (radiologists, oncologists, medical physicists etc.) in performing contouring/delineation of the prostate gland in images in multiple modalities more efficiently. The software is capable of segmenting the prostate gland in individual slices, in a choice of different modalities, and for any given view (axial, sagittal, or coronal). This is done by requiring some user input (clicks or drawing ROIs).

For volume prostate data. Segasist P-AC calculates the prostate volume in cubic centimeters and displays the contours on each slice. The results (contours) can be saved as DICOM or binary images (BMP), which can be edited/modified at any time, completely dismissed or accepted and saved by the end user.

The efficiency of contouring performed by the Segasist P-AC software may be improved by generating/using an advanced atlas using gold standard images created by the experienced clinician(s). This requires the software to be trained (atlas creation) before being used. The software can be delivered pre-trained with the comprehensive atlas or the end user can generate their own atlas; a well-established practice for atlas-based segmentation software products.

Segasist P-AC also offers a built-in editor, enabling the user to edit, modify, or change the extracted prostate boundaries to their desired configuration based on their medical and clinical knowledge and experience. The results provided by the Segasist P-AC software needs to be approved by the experienced clinician and can always be modified or corrected by him/her. In addition, the end user can delineate the prostate gland manually using the P-AC software, if necessary or desired. As a result, when Segasist P-AC generates a result, the expert user always has the final decision to override the software result, if deemed appropriate in his/her clinical judgment. It is up to the expert user to accept the result without any change, reject it completely and delineate manually, or modify the Segasist P-AC result and then save it. The software does not provide any auto-detection or auto-saving functionalities. Regardless of the accuracy of Segasist P-AC result. it is always the experienced clinician that remains the decision maker regarding the acceptability of the computed segmentation. Therefore, the final decision on diagnosis, treatment and overall management of the patient is not based on the software result.

Segasist P-AC software does not alter the original input images of the prostate gland. nor does it change the final results obtained once approved by the clinical expert.

Segasist P-AC offers several features and functionalities such as, but not limited to:

• . Import/Export DICOM images
• . Saving Contours to DICOM or BMB format
• . Semi-automated Segmentation
• . Auto-Segmentation (fast slice-to-slice auto-segmentation with minimal user interactions)
• . Volume Segmentation and measurement
• . Edge Enhancement (contour enhancement by user controlled edge snapping).
• . Standard Functionalities for Image Visualization (windowing, contrast, brightness, zoom, panning etc)
• . Advanced Functionalities for Contour Editing For Manual Segmentation (drawing, inflating, deflating, shifting, cut & add etc)
• . User access to modify the resulting contours at any time

Here's an analysis of the Segasist Prostate Auto-Contouring Software based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or specific reported device performance metrics (e.g., Dice score, Hausdorff distance, sensitivity, specificity) for the Segasist P-AC software. The document focuses on demonstrating substantial equivalence to predicate devices and describes the software's functionalities and validation approach.

However, based on the text, the implicit acceptance criteria are that the device "works as intended" and "was acceptable for clinical use, and did not introduce any new concerns of safety or effectiveness compared to predicate products or manual contouring of the prostate gland." The performance is reported as meeting these general criteria.

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

• Sample Size for Test Set: The document states that "imported prostate image datasets from the various imaging modalities were used as input for testing of the software functionalities in accordance with the software validation/verification plans." It also mentions "sufficient numbers to support the intended use of the device." However, a specific number for the test set sample size is not provided.
• Data Provenance: The document does not explicitly state the country of origin for the image data used in testing. It only mentions "imported prostate image datasets." It implies these were retrospective clinical test cases, as it refers to "bench testing using imported images from the various imaging modalities" and "clinical test cases."

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

• Number of Experts: The document details the software development process involved "the input and collaboration of experienced and trained professionals, such as radiologists, oncologists or other highly qualified medical clinicians." For the independent testing, it states "independently by experienced and trained medical professionals who are representative of the commercial end users." However, a specific number of experts used to establish ground truth for the test set is not provided.
• Qualifications of Experts: The experts involved in development and testing are described as "radiologists, oncologists or other highly qualified medical clinicians that are proficient in reading, evaluating and interpreting images of the prostate produced by MR, CT or ultrasound devices." Specific years of experience are not mentioned, but the description emphasizes their proficiency and experience.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1 or 3+1). It states that the "input was captured in a written and approved Software Requirement Specifications Document" and testing was conducted "both internally at Segasist Technologies and independently by experienced and trained medical professionals." The final contours generated by the software are subject to review and modification by the clinician, indicating a human-in-the-loop approach where the expert has the final say. However, for the initial ground truth used to evaluate the algorithm itself, the method is not detailed.

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 as described in this document. The submission focuses on demonstrating substantial equivalence and the software's functional validation, rather than an explicit comparative effectiveness study showing improvement with AI assistance for human readers using quantitative metrics (e.g., sensitivity, specificity, reading time reduction). The device is positioned as a "compliment to manual contouring techniques," implying assistance, but without a formal study to quantify the improvement.

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

Yes, a standalone performance assessment was implicitly done. The document describes "bench testing" using "imported images" to determine if the "Segasist P-AC software works as intended." While the intended use involves human oversight and modification, the initial evaluation of the software's ability to generate contours (before human intervention) constitutes a form of standalone performance assessment. The "Segasist P-AC calculates the prostate volume in cubic centimeters and displays the contours on each slice," representing its standalone output.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the test set appears to be expert consensus or expert-defined contours. The document states that "input and collaboration of experienced and trained professionals" guided development, and "independent... medical professionals" tested the software using "clinical test cases." The creation of "an advanced atlas using gold standard images created by the experienced clinician(s)" further supports that expert-defined contours were used as the reference. There is no mention of pathology or outcomes data being used as ground truth for contouring accuracy directly, though the software's use is indicated for diagnosis and treatment planning, where such data would eventually be relevant.

8. The Sample Size for the Training Set

The document mentions that the software "can be delivered pre-trained with the comprehensive atlas or the end user can generate their own atlas." Training involves "atlas creation." However, the specific sample size used for the pre-trained comprehensive atlas (the training set) is not provided.

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

The ground truth for the training set (the "comprehensive atlas" or user-generated atlases) is established by experienced clinician(s). The document states, "The efficiency of contouring performed by the Segasist P-AC software may be improved by generating/using an advanced atlas using gold standard images created by the experienced clinician(s)." This indicates that human experts manually contoured the images that form the basis of the atlas used for training.

Ask a specific question about this device

1. Both the RAD II KV Imager and RAD II Simulator are used in the field of Radiation Therapy as diagnostic imaging devices for patient positioning verification prior to radiation therapy treatments for cancer.
2. Both the RAD II KV Imager and RAD II Simulator are permanently mounted to the Therapy Head of Linear Accelerators and Cobalt Teletherapy devices.
3. The RAD II KV Imager is an "On Board Imager" intended for usage as a patient positioning verification device.
4. The RAD II KV Imager uses digital imaging to acquire its images, and positioning software to verify and/or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.
5. The RAD II Simulator is a "Therapy Attached" Simulator intended for developing and or verifying patient treatment protocols as prescribed by Radiation Oncologist.
6. The RAD II Simulator device uses standard x-ray film to acquire its images, which are reviewed by the Therapist and or Oncologist to either verify or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.

The RAD II KV Imaging device is mounted directly to the head of a Linear Accelerator or Cobalt Therapy device. This "Therapy Attached" application has been in use as the RAD II Simulator since 1983 (510K # K834281). With the addition of an FDA approved Digital Imager and Patient Positioning Software, the RAD II KV Imager operates as an "On Board Imaging Device" for Image Guided Radiation Therapy (I.G.R.T.) Protocols.

This 510(k) summary for the Acceletronics RAD II Simulator & RAD II KV Imager focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study proving performance against those criteria.

Therefore, many of the requested sections regarding specific acceptance criteria, detailed study results, sample sizes, expert qualifications, and ground truth establishment are not provided in this document. The document primarily relies on comparing the technological characteristics and intended use of the RAD II devices to previously cleared devices.

Here's a breakdown of the information available and what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the RAD II Simulator & RAD II KV Imager. Instead, it claims substantial equivalence based on:

• Technological Characteristics: As detailed in Exhibit C-4 (page 2), comparing components like X-ray tube, generator, imager type (digital vs. film), and software with predicate devices.
• Intended Use: For verification of patient position and treatment fields in radiation therapy.

Example Comparison (from Exhibit C-4, not formal acceptance criteria):

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

• Not provided. The submission focuses on substantial equivalence based on technical specifications and intended use, not on specific clinical or performance testing data with a defined test set.

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

• Not provided. There is no mention of a test set with established ground truth or expert involvement in such a process within this document.

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

• Not provided. Due to the absence of a described test set and ground truth establishment, no adjudication method is mentioned.

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

• Not applicable/Not provided. This submission is for a device that aids in patient positioning and image acquisition in radiation therapy. It is not an AI-assisted diagnostic tool for human readers in a way that an MRMC study on reader improvement would typically be conducted. Therefore, no information on human reader improvement with/without AI assistance is presented.

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

• Not provided. The document does not describe a standalone performance study. The device is intended to be used by radiation therapists and oncologists for patient positioning verification. The "standalone" performance in this context would likely refer to the image quality and accuracy of positioning measurements, but specific studies are not detailed.

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

• Not provided. As there is no described performance study or test set, the type of ground truth used is not mentioned.

8. The sample size for the training set

• Not applicable/Not provided. This device is a hardware and software system for image acquisition and patient positioning, not a machine learning model that requires a "training set" in the conventional sense. The "Theraview Software" is mentioned, but its development process (e.g., if it uses machine learning and thus a training set) is not detailed.

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

• Not applicable/Not provided. (See point 8)

Summary of what is available and the overall approach:

The manufacturer, Acceletronics, Inc., is seeking 510(k) clearance for the RAD II Simulator & RAD II KV Imager by demonstrating substantial equivalence to predicate devices. This means they are asserting their device is as safe and effective as devices already on the market without needing to conduct extensive new clinical trials to prove efficacy from scratch.

• Predicate Devices: Several predicate devices are identified, including Varian Medical Systems On-Board Imager, Varian Medical Systems Portal Vision, Elekta Synergy, Oldelft Simulux-HP, and Haynes Radiation Ltd., Inc. RAD II Simulator.
• Description of Equivalence: The submission highlights that the RAD II KV Imager operates as an "On Board Imaging Device" for Image Guided Radiation Therapy (IGRT) protocols, similar to predicate devices A-C. The RAD II Simulator is likened to predicate devices D&E as a "Radiation Therapy Simulator."
• Technological Characteristics Comparison (Exhibit C-4): This table compares specific components and features (X-ray tube, generator, imager type, software) of the RAD II systems with the predicate devices, emphasizing their similarities. The key difference noted for the RAD II KV Imager is its advanced digital imaging compared to the older film-based RAD II Simulator, and some differences in imager/cassette mounting designs.
• Intended Use Statement: The intended uses for both the KV Imager (patient position verification) and the Simulator (developing and verifying treatment protocols) are clearly stated and aligned with the intended uses of the predicate devices.

In essence, the "study" mentioned is the comparison of the device's technical specifications and intended use to legally marketed predicate devices, which is the basis for a 510(k) clearance. Clinical performance data or specific acceptance criteria with supporting studies are generally not required for substantial equivalence claims unless there are significant technological differences or new indications for use.

Ask a specific question about this device