(28 days)
Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography).
Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
Mobius3D (v. 3.0) is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It is important to note that while Mobius3D operates in the field of radiation therapy, it is neither a radiation delivery device (e.g. a linear accelerator), nor is it a treatment planning system (TPS). Mobius3D cannot design or transmit instructions to a delivery device, nor does it control any other medical device. Mobius3D is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software-only QA tool, Mobius3D never comes into contact with patients.
Mobius3D performs dose calculation verifications for radiation treatment plans by doing an independent calculation of radiation dose. Radiation dose is initially calculated by a treatment planning system (TPS), which is a software tool that develops a detailed set of instructions (i.e. a plan) for another system (e.g. a linear accelerator) to deliver radiation to a patient. The dose calculation performed by Mobius3D uses a proprietary collapsed cone convolution superposition (CCCS) algorithm.
Mobius3D also performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a linear accelerator's delivery log files to calculate a delivered dose. This is presented to the end user in a software component of Mobius3D called MobiusFX. The MobiusFX component is available to users through licensing as an add-on to the core Mobius3D software features.
Mobius3D performs quality assurance of a patient's alignment and anatomy analysis. This analysis is based on comparison of Cone Beam Computed Tomography (CBCT) images taken immediately before treatment to the images used for treatment planning, which are typically acquired using standard Computed Tomography (CT). This analysis is presented to the end user in an add-on software module within Mobius3D called CBCT Checks.
The provided text discusses the Mobius3D v3.0 device, its intended use, and its classification, but it does not include detailed information regarding specific acceptance criteria for its performance or the study that definitively proves the device meets those criteria with granular data as requested.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
Missing. The document states that "Software verification and validation was conducted" and that "The non-clinical data support the safety of the device and the software verification and validation demonstrate that subject device should perform as intended in the specified use conditions." However, no specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) or the acceptance thresholds for these metrics are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing. No information on the sample size of any test sets, the origin of data, or whether it was retrospective or prospective is present.
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)
Missing. There is no mention of ground truth establishment, experts involved, or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing. The document does not describe any adjudication methods.
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
Missing. The document states, "No animal studies or clinical tests have been included with this pre-market submission." This indicates that no MRMC comparative effectiveness study with human readers was conducted or submitted with this application.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Partially Addressed / Implied. The device, Mobius3D, is a "software product used within a radiation therapy clinic for quality assurance and treatment plan verification" that "performs dose calculation verifications" and "dose delivery quality assurance." It uses a "proprietary collapsed cone convolution superposition (CCCS) algorithm" for dose calculation. This implies that the dose calculation and QA checks are performed by the algorithm in a standalone manner, generating results for "trained radiation oncology personnel" to review. However, the exact performance metrics of this standalone algorithm are not detailed. The phrase "software verification and validation document that subject device should perform as intended" obliquely refers to studies on the algorithms performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing. No specific type of ground truth is mentioned. Given the nature of the device (dose calculation and QA), the ground truth for performance evaluation would likely involve highly accurate physical measurements or very precise computational models, but this is not specified.
8. The sample size for the training set
Missing. No information about a training set or its sample size is provided. The document focuses on regulatory approval based on "software verification and validation" and comparison to a predicate device.
9. How the ground truth for the training set was established
Missing. As no training set is mentioned, there is no information on how its ground truth might have been established.
Summary of available information related to the "study":
The document mentions that "Software verification and validation was conducted" and that "The non-clinical data support the safety of the device and the software verification and validation demonstrate that subject device should perform as intended in the specified use conditions." This suggests that internal testing and validation activities were performed by the manufacturer.
The device is a "Special 510(k) Submission" for a "major" level of concern software device. This indicates that the review focused on demonstrating substantial equivalence to a predicate device (Mobius3D v2.2, K191761) and verifying that changes (like the introduction of the MobiusAdapt module) do not raise new questions of safety or effectiveness. Conformance to standards like IEC 62304, IEC 62366-1, and IEC 61217 is also noted.
In conclusion, while the document confirms that verification and validation were performed to support substantial equivalence, it does not provide the specific details of performance criteria, study design, sample sizes, ground truth establishment, or expert involvement that you have requested.
§ 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.