(247 days)
The BeamSite™ System is intended to be used only with photon external beam radiotherapy during treatment to acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated. BeamSite is used by radiotherapy professionals in appropriate hospital and freestanding radiation therapy environments.
BeamSite™ is a system that enables real-time visualization of the treatment beam on a patient during radiotherapy. It is an optically based system that is non-patient contacting and produces no radiation. BeamSite captures images of Cherenkov light emitted from the patient's skin during radiotherapy to provide an optical map of the beam on the patient. The BeamSite system consists of a camera, workstation with pre-installed BeamSite software and a monitor to be used by clinical radiotherapy teams to visually observe the treatment, as it happens, and review after the treatment, if necessary.
The BeamSite system is designed to be used as a fixed mounted camera having a field of view of the treatment area, to routinely image patient treatments with minimal impact to the clinical workflow. The video images produced are intended to provide additional information about the treatment for the clinical team by displaying the beam size and shape on the patient during treatment. The images produced will provide real-time, direct visual indication that the beam is on, that it is impacting the patient at the intended treatment surface, provides visual feedback regarding the patient's movement relative to the beam, and that surfaces of the body not intended for treatment remain outside the beam path. BeamSite is to be used as a visualization tool. Therapeutic decisions should not be made solely based on the images acquired from this device. However, the images will provide a simple and intuitive means to visually monitor radiation therapy on a routine basis.
The provided text is a 510(k) summary for the DoseOptics BeamSite™ System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a new clinical claim or an AI algorithm's diagnostic performance. Therefore, many of the requested details regarding acceptance criteria, ground truth, expert adjudication, and MRMC studies, which are typical for AI/ML-based diagnostic devices, are not explicitly present in this document.
The BeamSite™ System is described as an optical visualization tool for radiotherapy, showing the beam shape relative to surface anatomical landmarks. It is not an AI/ML diagnostic or assistive device in the sense that it provides a specific diagnosis, classification, or modifies treatment decisions based on an AI's output. Its primary function is to provide visual feedback to human operators.
Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific performance acceptance criteria for the visualization capabilities of the BeamSite System, nor does it quantify its diagnostic performance. The performance testing summarized primarily relates to functional verification, safety (electrical, EMC), software V&V, and usability, which are general engineering and regulatory compliance tests rather than benchmarks for clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic task).
The "Performance Testing Summary (Non-Clinical)" section lists the types of tests conducted:
| Test Type | Description/Reported Performance |
|---|---|
| BeamSite functional verification testing | (system, software and firmware) - Implied successful completion, but no specific metrics or acceptance criteria are provided. |
| Accelerated age testing | (to support expected service life claim for the BeamSite Camera) - Implied successful completion, but no specific metrics or acceptance criteria are provided. |
| Electrical Safety Evaluation | as per IEC 60601-1:2005 / (R) 2012 and A1: 2012 - Implied compliance. |
| Electromagnetic Compatibility testing | as per IEC 60601-1-2: 2014 - Implied compliance. |
| Software Verification and Validation | as per IEC 62304:2006 / A1: 2016 - Implied compliance. |
| Usability Testing | as per IEC 60601-1-6 Edition 3.1 2013-10 and IEC 62366-1: 2015 - Implied compliance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance testing described is "non-clinical," implying it was not a patient-based clinical trial. If any data was used for functional verification or usability testing, the sample size and provenance are not specified. Given the device's function as a real-time visualization tool and its substantial equivalence argument, a large test set of patient images with verified ground truth (as would be needed for an AI diagnostic device) is not described here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As "ground truth" for diagnostic performance is not within the scope of this non-clinical testing summary, no experts are mentioned for this purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable given the nature of the tests described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was conducted or reported. This device is not an AI-assistive diagnostic tool that would typically undergo such a study. It provides raw visual information, and its purpose is not to improve human reader performance on a diagnostic task, but rather to give immediate feedback on beam delivery.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not explicitly stated or implied. The device is a "system consisting of a camera, workstation with pre-installed BeamSite software and a monitor to be used by clinical radiotherapy teams to visually observe the treatment." It is inherently a human-in-the-loop device, and standalone algorithm performance, separate from human interpretation, is not a relevant measure for its function.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As no clinical performance claims (e.g., diagnostic accuracy) are being made based on this device's output, the concept of "ground truth" for clinical images (like expert consensus or pathology) is not applicable or mentioned in this summary. The device visualizes Cherenkov light, which itself is a direct physical phenomenon related to the beam.
8. The sample size for the training set
This information is not provided. The document does not describe the use of machine learning or deep learning that would typically involve a "training set."
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no mention of a training set or machine learning.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.