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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:

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

The document mentions "Additional bench testing using improved measurement technique has been performed to substantiate improved claims" for both positioning accuracy and respiratory tracking. However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for these tests. The testing appears to be conducted on a calibration phantom, not on human subjects.

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

This information is not provided in the document. The testing appears to be an objective measurement against a known physical standard (calibration phantom), rather than based on expert interpretation of medical images.

4. Adjudication method for the test set:

This information is not applicable/not provided. The performance evaluation is based on direct measurements against physical standards, not on subjective assessment by multiple reviewers.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this document. The AlignRT Plus is a patient positioning and monitoring system, not primarily an AI diagnostic tool for image interpretation that would involve human readers.

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

The performance metrics provided for Positioning Accuracy and Respiratory Tracking (target registration errors, RMS errors) likely represent standalone algorithm performance as measured against a physical phantom. The system's function is automated measurement and feedback.

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

The ground truth used for the performance testing appears to be objective physical measurements from a calibration phantom with known parameters (e.g., precise positions, controlled respiratory movements).

8. The sample size for the training set:

The document does not provide information on the sample size for the training set. As a vision-based system for physical tracking, much of its core functionality would be based on geometric algorithms rather than extensive machine learning training data in the traditional sense of medical image analysis. It's possible internal validation or calibration data was used, but details are not given.

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

This information is not provided in the document. Similar to the training set size, details about how any ground truth for potential internal calibration or training was established are not mentioned.

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