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The AlignRT Plus system is indicated for:

• · Tracking respiratory motion throughout the simulation process to facilitate subsequent 4DCT reconstruction and coaching the patient in breathing techniques required for Deep-Inspiration Breath Hold (DIBH).
• · Verification of patient identity for their radiation treatment session.
• · Positioning and monitoring of patients during radiation delivery, relative to the setup isocenter and/or the prescribed treatment isocenter.
• · Withholding the beam automatically during radiation delivery, as well as gating the patient's respiratory motion.
• · Performing quality assurance on MV, kV imagers, room lasers, and the treatment couch.
• · Visualizing the Cherenkov signal associated with the radiation beam on entry and exit from the patient.
• · Passing and receiving information to/from other systems associated with the radiotherapy treatment.

The AlignRT Plus system (K212583) is a combination of the devices AlignRT InBore, AlignRT Offline, DoseRT, GateCT, GateRT and SimRT.

AlignRT Plus is a video-based three-dimensional (3D) surface imaging system used to monitor the patient's position in 3D before and during radiotherapy treatment. During each treatment session the patient's position is compared to the reference surface and offsets are displayed to the user. The system can be used to track pation during tumour localization in the CT scanner in order to facilitate subsequent 4D CT reconstruction. The system can be used to track the breath hold level consistency throughout the simulation process. The system can also be used to track patient motion during treatment delivery for radiation therapy procedures and hold the beam when the patient is not in position. Use of optional accessories allows the user to:

• monitor the patient's position inside bore-based linacs; and/or —
• to view the Cherenkov light emitted by the radiation beam as it enters and exits the patient's skin; and/or
• verify the patient's identity.

The system is non-invasive, does not require the use of body markers and produces no irradiation during the imaging process. The system mainly consists of advanced software. 3D cameras (≤6 cameras) and calibration tools. Each camera pod monitoring the pation will, however, project a pattern on the patient to acquire a 3D image of the patient.

This 510(k) notification is to obtain clearance for the following changes to the cleared device:

• 1. Introduction of new software, version 7.3. This is an updated version of the existing cleared software, to support the:
  • a. New Cherenkov imaging feature, called DoseRT.
  • b. Updated respiratory gating feature, called Respiratory Module.
• 2. Introduction of new hardware:
  • a. DoseRT camera to enable Cherenkov imaging.
• 3. Update to indications for use to include the new Cherenkov imaging feature and clarify existing indications.

The provided document describes the AlignRT Plus 7.3 system, a surface-guided radiation therapy system. However, it does not contain detailed acceptance criteria and a study dedicated to proving the device meets those criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (AlignRT Plus K212583) and a reference device (BeamSite K212606) for new features, primarily Cherenkov imaging and an updated respiratory module. It mentions "Verification tests were performed to ensure that the module works as intended and pass/fail criteria were used to verify requirements. Validation testing was performed using summative evaluation techniques per IEC 62366-1:2015. Verification and validation testing passed in all test cases." but does not provide details of these tests, specific acceptance criteria, or the results.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a summary of the information that can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations.

AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment.

Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning.

AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

The AlignRT Plus system (K203387) is a combination of the devices AlignRT, GateCT and GateRT.

AlignRT Plus is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is non-invasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process.

AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals.

Real-time imaging and surface matchinq of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances.

Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals.

AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position.

Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS). This is provided with the brand name "AlignRT SRS module".

The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT.

This 510(k) is requested for a modifications to FDA 510(k) cleared product "AlignRT Plus" (K203387).

This 510(k) is to obtain clearance for the following changes to the cleared device:

• Introduction of new software, SimRT 7.2. This is an updated version of the cleared software, GateCT, with a new user interface similar to the cleared AlignRT 6.2/6.3/6.4 software;
• 2. Introduction of new camera pods (hardware). These function in the same way as the currently cleared hardware but are aesthetically different and have upgraded capabilities to support future product development;
• 3. Improve the product's accuracy claim for Source-Surface Distancing (SSD) from

The provided text is a 510(k) Premarket Notification for the AlignRT Plus system. It details modifications to an already cleared device. The key information regarding acceptance criteria and device performance is found under the "System Performance and Accuracy" section within the "Summary of the Technological Characteristics" table.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations.

AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment.

Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning.

AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

The AlignRT Plus system (K193431) is a combination of the devices AlignRT, GateCT and GateRT. A special 510(K) K193431 was submitted by Vision RT Ltd. in December 2019 and this was cleared by FDA in January 2020 for the changes and improvements made in AlignRT.

AlignRT Plus is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is non-invasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process.

AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals.

Real-time imaging and surface matching of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances.

Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals.

AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position.

Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS). This is provided with the brand name "AlignRT SRS module".

The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT.

This 510(k) is requested for a new optional InBore camera and a change in memory size for an existing FDA 510(k) cleared product "AlignRT Plus" (K193431).

The InBore camera is optional hardware for use with bore-based linear accelerators.

The increase in memory size from 32 to 64bit increases the system's processing speed, enabling a frame rate improvement.

The provided text is a 510(k) Premarket Notification for the AlignRT Plus device K203387, which describes modifications to an existing cleared device K193431. The document does not contain a detailed study that proves the device meets specific acceptance criteria with supporting data, an approach often seen for substantial equivalence claims where modifications are minor and performance remains unchanged from a previously cleared predicate. Instead, it relies on demonstrating that the modified device's performance and characteristics are the same as its predicate device.

Therefore, the following information is based on what is stated and what can be inferred from the provided text, primarily focusing on the comparison to the predicate device.

Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" for this submission are fundamentally defined by the performance of the predicate device (K193431). The "Reported Device Performance" for the modified device (K203387) is stated to be unchanged from that of the predicate.

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The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations.

AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment.

Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning.

AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

AlignRT Plus is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is noninvasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process.

AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals.

Real-time imaging and surface matching of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances.

Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals.

AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position.

Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS). This is provided with the brand name "AlignRT SRS module".

The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT.

This Special 510(k) is requested only for software modification for an existing 510(k) cleared product "AlignRT Plus" (K181218). No hardware or material changes have been made since its last 510(k) clearance. The two key changes made in the existing AlignRT v6.0 software which are the subject of this Special 510(k) are listed below;

1. System Frame Rate improvement
2. Addition of Video Postural Setup Alignment feature

I am sorry, but I lack the ability to provide a response without the full context of the document. The request references information within the document that is not provided in a conversational format. If you can provide the specific details about the acceptance criteria and study, I would be happy to help describe them.

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The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations.

AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment.

Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning.

AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

The AlignRT Plus system (K123371) is a combination of the devices AlignRT, GateCT and GateRT. It is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is noninvasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process.

AlignRT Plus is also able to perform both respiratory synchronised CT imaging and treatment delivery. In both instances, the system acquires a gated 3D surface model of the patient. User selected points are then tracked in real time in order to provide gating and position monitoring signals.

Real-time imaging and surface matching of the patient is possible during both setup and the treatment delivery to determine any patient movement. During treatment delivery, AlignRT Plus is also able to withhold the beam automatically, should the patient move outside user-defined tolerances.

Patient contour data may be extracted from surface data acquired by the system and exported for the purpose of treatment planning by radiotherapy professionals.

AlignRT Plus may be calibrated directly to the treatment beam isocentre using an optional custom designed calibration phantom and image processing software. It can analyse MV and kV digital imaging data acquired by other cleared devices. This in turn assists the user in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.

The AlignRT Plus system includes the optional Head Adjuster for cranial treatments to allow for the manual, fine correction of pitch, roll and yaw in the patient's head position.

Precise isocenter calibration and the optional Head Adjuster provide improved frameless Stereotactic Radiosurgery (SRS). This is provided with the brand name "AlignRT SRS module".

The AlignRT Plus system is also provided under the brand OSMS (Optical Surface Monitoring System). This product is identical to AlignRT.

The provided text describes the AlignRT Plus system, a video-based three-dimensional (3D) surface imaging system used for patient positioning and monitoring during radiotherapy.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition therapy treatment. Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning. AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

AlignRT Plus system is a combination of the predicate devices AlignRT (K052682) and GateCT-RT (K072171). It is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is non-invasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process.

Acceptance Criteria and Study for AlignRT Plus

The AlignRT Plus system is a video-based three-dimensional (3D) surface imaging system used to position and monitor patients during radiotherapy treatment. The following describes its acceptance criteria and the study demonstrating its performance.

1. Table of Acceptance Criteria and Reported Device Performance

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The AlignRT system is used to position patients at the isocentre of the linear accelerator for radiation therapy procedures. Patient contour data can be extracted and exported from the acquired data for the purpose of treatment planning. AlignRT is used by radiotherapy professionals in appropriate hospital environments. It can be used with all types of radiotherapy patients and can image any visible anatomical region. The system is completely non-invasive and does not require the application of any external markers to the patient.

AlignRT is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, two 3D camera units, cables, and templates that are used for camera calibration. The system is non-invasive, does not require the use of body markers and produces no irradiation during the imaging process. AlignRT first generates a reference surface of the optimum treatment position determined during treatment simulation. This reference image is generated by either recording the surface of a patient placed in a conventional radiotherapy simulator in which the system is installed or by importing skin contours from CT (X-Ray Computer Tomography) volumetric data generated via third party treatment planning software. Prior to each treatment session the patient's position is imaged and compared to the reference image by the system's surface matching software. Where movement from the reference position is detected the software calculates new co-ordinates to adjust the treatment couch for optimal positioning of the patient. The system is designed to interface directly with certain third party couch control systems. In order to minimise the setup errors that can result from respiratory motion, an option is available to gate the image capture of the system so that all data is acquired at a repeatable point within the breathing cycle such as the end of exhalation. Real-time imaging (1 frame/sec) of the patient is possible during the actual treatment and software verification tools are provided in order to determine any patient movement. Patient contour data may be extracted from surface data acquired by the system. In addition, lung contour data may be estimated by utilising AlignRT 3D surface data and 2D X-ray data acquired from either a conventional simulator or portal imager. These data may be exported for the purpose of treatment planning by radiotherapy professionals.

Based on the provided 510(k) summary (K052682) for the AlignRT system, the following information regarding acceptance criteria and study details can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K052682) is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with explicit acceptance criteria and corresponding performance metrics for a novel technology. Therefore, the "acceptance criteria" listed below are inferred from the device's stated purpose and comparison to predicates, and the "reported device performance" is a general statement from the summary. Specific quantitative metrics are not detailed in this document.

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

The 510(k) summary does not explicitly state a sample size for a test set or any details about data provenance (e.g., country of origin, retrospective or prospective data) for a specific clinical study. General "performance data" is mentioned as being submitted, but the specifics are not included in this publicly available summary.

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

The 510(k) summary does not provide information regarding the number of experts, their qualifications, or how ground truth was established for any specific test set. The device's function involves comparing to a "reference surface" determined during "treatment simulation" or from "CT volumetric data," which implies clinical input from radiotherapy professionals, but specific details about establishing ground truth for validation are absent.

4. Adjudication Method for the Test Set

The 510(k) summary does not describe any adjudication method used for a test set.

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

The 510(k) summary makes no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with or without AI assistance. The AlignRT system is presented as a positioning and monitoring tool for radiotherapy, not an AI-assisted diagnostic or interpretive tool for human readers in the traditional MRMC sense.

6. Standalone (Algorithm Only) Performance Study

The document states that "performance data has been submitted to show that AlignRT achieves its intended use." This implies that a standalone performance evaluation of the system's capabilities (e.g., accuracy of 3D surface imaging, precision of position detection, correlation with actual patient movement) was likely performed and submitted to the FDA. However, the details of such a standalone study, including specific metrics and methodologies, are not present in this summary. The core of the device is its algorithm for surface matching and coordinate calculation.

7. Type of Ground Truth Used

The ground truth for the core function of the AlignRT system is implicitly related to:

• The "optimum treatment position determined during treatment simulation." This would be established by radiotherapy professionals.
• "Skin contours from CT (X-Ray Computer Tomography) volumetric data" which are considered a gold standard for anatomical representation in radiotherapy planning.
• "2D X-ray data acquired from either a conventional simulator or portal imager" when estimating lung contour data.

Therefore, the ground truth leans towards expert consensus (for optimal treatment position) and imaging modalities considered high-fidelity anatomical references (CT, X-ray). Pathology or outcomes data are not mentioned as direct ground truth for this positioning device.

8. Sample Size for the Training Set

The 510(k) summary does not provide any information regarding the sample size of a training set. Given the described functionality (3D surface imaging, matching, coordinate calculation), the system likely relies on image processing algorithms that might be trained or calibrated, but details are not disclosed.

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

Since no information on a training set is provided, there is correspondingly no information on how its ground truth was established.

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