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510(k) Data Aggregation
(68 days)
VISION RT LIMITED
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
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Positioning Accuracy | Target registration errors (as measured using calibration phantom) |
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(56 days)
VISION RT LIMITED
The GateCT-RT system is used to obtain tracking of the subject's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. It can be also used, either independently or in conjunction with Vision RT's AlignRT (K052682), to monitor the patient position during the image acquisition, simulation and treatment and to disable the radiation beam automatically.
The GateCT-RT device is an attachment to radiation therapy treatment systems, simulators and image acquisition devices used for diagnostics and radiation therapy. The GateCT-RT system senses and records the respiratory motion and respiratory state of a patient using real time 3D surface tracking of the patient without the need of any externally positioned markers. Regions to be tracked are selected remotely in a location indicated by the physician on the GateCT-RT workstation. These may be automatically detected during subsequent sessions. GateCT tracks the patient's breathing CT acquisition in order to facilitate 4DCT reconstruction. GateRT tracks respiratory motion during treatment or imaging and automatically disables the beam when the breathing signal moves outside the user defined gating window. GateCT-RT may also be employed within the monitoring mode of AlignRT to disable the beam automatically if any patient movement is detected which exceeds a user defined tolerance. The Vision RT camera unit is connected to a PC workstation and is used for surface tracking of the patient.
The provided 510(k) summary for the GateCT-RT Respiratory Gating System does not contain specific details about acceptance criteria, a standalone study, or a multi-reader multi-case (MRMC) comparative effectiveness study with human readers. The information focuses on device description, intended use, and technological characteristics compared to predicate devices for substantial equivalence.
Therefore, many of the requested sections regarding study specifics cannot be extracted from this document, as this type of information is generally not included in a 510(k) summary, which primarily establishes substantial equivalence to predicate devices.
However, based on the provided text, I can infer some aspects related to the purpose of such a device, and answer what info is available.
Here's the breakdown of what can and cannot be answered from the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics from a study (e.g., accuracy, precision of respiratory tracking). It focuses on technological characteristics and intended use for substantial equivalence.
| Acceptance Criteria (Inferred from Intended Use) | Reported Device Performance (Not present in document) |
|---|---|
| Obtain tracking of subject's respiratory pattern | (No specific performance metrics reported in this summary) |
| Facilitate 4DCT reconstruction | (No specific performance metrics reported in this summary) |
| Track respiratory motion during treatment/imaging | (No specific performance metrics reported in this summary) |
| Automatically disable beam when breathing signal moves outside user-defined gating window | (No specific performance metrics reported in this summary) |
| Monitor patient position during image acquisition, simulation, and treatment | (No specific performance metrics reported in this summary) |
Sample Size and Data Provenance
The document does not describe any specific clinical or performance studies with sample sizes. It is a 510(k) summary primarily focused on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.
Number of Experts and Qualifications for Ground Truth
The document does not describe any study involving experts to establish ground truth.
Adjudication Method
The document does not describe any study, and therefore, no adjudication method is mentioned.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned in the provided text. The submission focuses on device characteristics, not on comparative effectiveness with human readers.
Standalone Performance Study
The document does not explicitly describe a standalone performance study with quantitative results. While the device itself performs tracking, the submission does not include a study demonstrating its standalone accuracy or precision against a gold standard.
Type of Ground Truth Used
The document does not describe any study, and therefore, no ground truth type is mentioned.
Sample Size for Training Set
The document does not refer to any training set or machine learning model, and thus no sample size for a training set is provided.
How Ground Truth for Training Set was Established
The document does not refer to any training set, and thus no method for establishing its ground truth is provided.
Summary of what is available from the 510(k) Summary:
The provided document is a 510(k) summary, which is a submission to the FDA for medical device clearance based on substantial equivalence to predicate devices. It typically describes the device, its intended use, and compares its technological characteristics to existing legally marketed devices. It generally does not include detailed clinical study data, performance metrics, or information about training/test sets, expert adjudication, or MRMC studies, unless these were part of specific tests needed to prove substantial equivalence for unique characteristics. In this case, the clearance seems to be based on comparison of technological characteristics rather than a new standalone clinical efficacy study.
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(100 days)
VISION RT LIMITED
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.
| Acceptance Criteria (Inferred from Device Purpose and Comparison) | Reported Device Performance (General Statement in Summary) |
|---|---|
| Ability to image the skin surface of a patient in 3D before and during radiotherapy treatment. | "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." |
| Capability to generate a reference surface of the optimum treatment position. | "AlignRT first generates a reference surface of the optimum treatment position determined during treatment simulation." |
| Comparison of patient's current position to the reference image. | "Prior to each treatment session the patient's position is imaged and compared to the reference image by the system's surface matching software." |
| Calculation of new co-ordinates to adjust the treatment couch for optimal patient positioning where movement is detected. | "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." |
| Real-time imaging capability during treatment to detect patient movement. | "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." |
| Ability to extract patient contour data. | "Patient contour data may be extracted from surface data acquired by the system." |
| Ability to estimate lung contour data by utilizing 3D surface data and 2D X-ray data. | "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." |
| No new efficacy or safety concerns compared to predicate devices despite technological differences. | "performance data has been submitted to show that AlignRT achieves its intended use and that these technological differences raise no new efficacy or safety concerns." |
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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