(58 days)
iViewDose is a standalone software tool, available as an optional accessory of the linear accelerator. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery, or impact the clinical workflow.
The software is to be used for the purposes of detecting gross errors during the delivery of radiation therapy. The software acquires data using the iViewGT Electronic Portal Imaging Device at the time of treatment) and subsequently processes it. The processed data is compared with data calculated by the treatment planning system. The comparison is derived from the application of dose conversion and reconstruction algorithms to the EPID data, which is back-projected to a plane normal to a beam (2D) or multiple planes (3D) inside the patient (in vivo) or phantom (pretreatment).
iViewDose is not a treatment planning system, and provides an independent means of checking the dose delivered to the patient.
iViewDose therefore provides an added level of treatment assurance, thus giving clinicians greater confidence especially when complex treatment techniques are employed.
iViewDose is intended to support decision making in relation to the delivery of radiation to defined target volumes performed with Elekta linear accelerators only.
This Traditional 510(k) describes a new standalone software to be used with the Elekta range of medical linear accelerators, to further enhance the existing functionality.
The iViewDose program uses iViewGT™ images to reconstruct the dose in 3D in the volume (patient or phantom). The program then uses a gamma analysis to compare the reconstructed dose with the TPS dose in 3D. iViewDose uses a dose reconstruction algorithm to calculate the dose in the patient from the dose delivered to the MV detector panel. The algorithm corrects for scattered radiation from the patient and the MV detector panel. You can use iViewDose in vivo to make an estimate of the delivered dose to a patient. You can also use iViewDose for pre-treatment checks to make an estimate of the delivered dose to a phantom.
The provided text is a 510(k) summary for the Elekta iViewDose R1.0 device. While it describes the device's functionality and its comparison to predicate devices, it does not contain a detailed study report with specific acceptance criteria or an analysis of its performance against those criteria in a formal study.
The document states: "Validation of the system under clinically representative conditions has been performed by competent and professionally qualified personnel. Results from verification and validation testing demonstrate that conformance to applicable technical design specification have been met and safety & effectiveness have been achieved." However, it does not provide the specifics of these tests.
It also mentions: "Although no clinical testing has been performed as part of the development, it can be shown that the algorithm at the core of the iViewDose product has been used extensively for a number of years. The data reviewed as part of this evaluation has been obtained from clinical sites. The data is presented in section 11 of this submission." This indicates that while there's no new clinical study specifically for this device, existing clinical data related to the underlying algorithm was reviewed. The specifics of "section 11 of this submission" are not included in the provided text.
Therefore, I cannot provide the requested information in a table format with specific metrics because the detailed acceptance criteria and performance study results are not present in the given document.
Here's what I can extract from the text regarding the nature of the evaluation, even without specific numbers:
Device Overview:
- Device Name: iViewDose R1.0
- Intended Use: A standalone software tool to assist in reducing clinical risk in radiotherapy treatments by detecting gross errors during delivery. It acquires data from the iViewGT Electronic Portal Imaging Device (EPID), processes it, and compares it with data calculated by the treatment planning system. It provides an independent means of checking delivered dose (in vivo or pre-treatment) and offers an added level of treatment assurance.
- Functionality: Reconstructs 2D or 3D dose from EPID images, uses gamma analysis to compare reconstructed dose with TPS dose, generates reports, shows % difference, volume analysis, total dose assessment, dose profiles, and EPID images. It's compatible initially with Monaco and Pinnacle TPS and Elekta linear accelerators.
Evaluation Information (based on general statements, not specific study data):
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided text. The document broadly mentions "conformance to applicable technical design specification have been met and safety & effectiveness have been achieved."
- Reported Device Performance: Not numerically reported in the provided text. The document states "This testing has shown that iViewDose is safe in use... Also, the use of iViewDose has been shown to have equivalent clinical efficacy when compared to the predicate devices..."
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Sample sized used for the test set and the data provenance: Not specified in the provided text. It mentions "data reviewed as part of this evaluation has been obtained from clinical sites," but details about the size or nature (retrospective/prospective, country of origin) of this data are absent.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. However, it indicates "Validation of the system under clinically representative conditions has been performed by competent and professionally qualified personnel."
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Adjudication method for the test set: Not specified in the provided text.
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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 mentioned as performed. The device is described as a "standalone software tool" for checking dose, not primarily as an AI assistant for human reading.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device is explicitly described as a "standalone software tool" and its function is to objectively compare reconstructed dose with planned dose. The performance claims ("conformance to applicable technical design specification have been met") likely refer to this standalone performance.
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The type of ground truth used:
- The primary comparison is between the dose calculated by the device (reconstructed from EPID data) and the data calculated by the treatment planning system (TPS dose).
- The TPS dose serves as the reference or "ground truth" for the comparison within the iViewDose system's operation.
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The sample size for the training set: Not specified in the provided text. The document refers to the algorithm having "been used extensively for a number of years" and data being "obtained from clinical sites," but does not provide details on training set size.
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How the ground truth for the training set was established: Not specified in the provided text. Given the device's function, it's likely that the "training" (or calibration/validation) of the dose reconstruction algorithm would involve comparisons to established dosimetry measurements (e.g., ionization chambers, film, TPS calculations on phantoms), but this is not detailed.
§ 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.