(116 days)
The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.
ARIA Radiation Therapy Management (ARIA RTM) manages several treatment information such as images and treatment data to prepare plans created for treatment and review post-treatment images and records. It also provides quality assurance options. ARIA RTM does not directly act on the patient. ARIA RTM is applied by trained medical professionals in the process of preparation and management of radiotherapy treatments for patients.
The provided FDA 510(k) summary for ARIA Radiation Therapy Management System (18.1) does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study proving device performance.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states: "Test results demonstrate conformance to applicable requirements and specifications." However, it does not provide a specific table of acceptance criteria or reported device performance metrics. It implies that underlying V&V documentation exists that confirms the software meets its design requirements, but these details are not present in this summary.
2. Sample size used for the test set and the data provenance
The document states: "No animal studies or clinical tests have been included in this pre-market submission." This indicates that the validation was likely based on non-clinical software testing, not patient data. Therefore, there is no patient-specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) mentioned. The testing would have involved simulated data, test cases, or internal datasets to verify software functionalities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since the testing was non-clinical software verification and validation, there is no mention of experts establishing ground truth for a test set in the traditional sense of clinical evaluation. Software testing typically relies on predefined requirements, specifications, and expected outputs, rather than expert-adjudicated ground truth from medical images or patient cases.
4. Adjudication method for the test set
Similarly, because there are no clinical trials or expert-adjudicated test sets, there is no adjudication method (e.g., 2+1, 3+1) 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
The document explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." Therefore, no MRMC comparative effectiveness study was conducted or reported for this submission. The device is a radiation therapy management system, not explicitly an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The submission indicates that the software underwent "Software Verification and Validation Testing" and was considered a "major" level of concern. This implies extensive standalone algorithm (software) testing to ensure it meets its functional and safety requirements. However, specific details of these tests (e.g., test cases, scenarios, and their results) are not provided in this summary. The device "does not directly act on the patient" and is "applied by trained medical professionals," suggesting it's an assistive tool within a human workflow, but its core functionalities are tested in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the non-clinical nature of the testing, the "ground truth" would have been established by the software requirements and specifications, test case design, and expected outputs defined by the developers. This is typical for software verification and validation, where the goal is to confirm the software performs as designed.
8. The sample size for the training set
The submission does not mention any training set as there is no indication of machine learning or AI models with external data training involved that would require such information. The changes appear to be feature enhancements to an existing software system.
9. How the ground truth for the training set was established
As no training set is mentioned, this information is not applicable.
In summary, the provided document focuses on the regulatory aspects of a software update (v18.1) to an existing device (v18.0) and highlights software verification and validation as the primary evidence of performance. It explicitly states that no clinical or animal studies were included. Therefore, the detailed performance metrics, test set characteristics, and expert involvement typically associated with clinical efficacy studies are not present.
§ 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.