(28 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.
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 supports the integration of all data and images in one central database including archiving and restoration. The different ARIA Radiation Therapy Management features support the visualization, processing, manipulation and management of all data and images stored in the system. Images can also be imported through using DICOM, the available image import filters or by means of film digitizers.
The provided text is a 510(k) summary for Varian Medical Systems' ARIA Radiation Therapy Management (v18.0) device. It describes the device, its intended use, comparison to a predicate device, and performance data from non-clinical testing.
However, the document does not contain the following information necessary to describe acceptance criteria and the study that proves the device meets those criteria:
- Specific acceptance criteria: The document mentions "applicable requirements were met" and "safeguards against hazards functioned properly" but does not detail what these specific quantitative or qualitative acceptance criteria were for the software verification and validation.
- Reported device performance: While it states "test results showed that applicable requirements were met," it does not provide any specific performance metrics or data (e.g., accuracy, precision, error rates) that were measured and compared against acceptance criteria.
- Sample size and data provenance for test set: No information is given about a test set, as all testing was non-clinical software verification and validation.
- Experts for ground truth and adjudication method: These are typically relevant for studies involving human interpretation or clinical endpoints, which this submission explicitly states were not conducted.
- MRMC comparative effectiveness study: The document clearly states that "No data from animal studies or clinical tests have been included" and "no animal or clinical studies were conducted for the subject device." Therefore, no MRMC study was performed.
- Standalone performance: Since no clinical studies were performed, there are no reported standalone performance metrics in the context of interpretation or diagnosis. The performance mentioned refers to software functionality.
- Type of ground truth: Ground truth is usually associated with clinical or pathological verification in studies, which are absent here.
- Training set information: As this is primarily a software update and management system, not a machine learning algorithm that requires a "training set" in the conventional sense, this information is not applicable and not provided.
Based on the provided text, I can only state what is mentioned regarding performance, rather than providing the requested table and details about a clinical study:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Applicable software requirements were met | Test results showed that applicable requirements were met |
| Safeguards against hazards functioned properly | Test results assured that safeguards against hazards functioned properly |
| Performs as intended in specified use conditions | Non-clinical data support the safety and demonstrate that ARIA Radiation Therapy Management should perform as intended |
| Software safety and effectiveness | ARIA Radiation Therapy Management is as safe and effective as the predicate |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The submission describes software verification and validation, not a test set of patient data.
- Data Provenance: Not applicable. Testing was based on software functionality and engineering requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set involving human interpretation or clinical ground truth was used.
4. Adjudication method for the test set:
- Not applicable. No test set requiring expert adjudication was used.
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, an MRMC comparative effectiveness study was not done. The document explicitly states: "No data from animal studies or clinical tests have been included in this pre-market submission" and "no animal or clinical studies were conducted for the subject device."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in the context of software verification and validation, the performance of the software (algorithm) was assessed standalone against its functional and safety requirements. However, this is not a standalone diagnostic performance study as typically understood for AI/ML devices. The document states: "The non-clinical data support the safety of the software verification and validation demonstrate that ARIA Radiation Therapy Management should perform as intended in the specified use conditions."
7. The type of ground truth used:
- For the software verification and validation, the "ground truth" was the specified engineering requirements, functional specifications, and regulatory standards (e.g., IEC 62304, IEC 62366-1, ISO 13485, ISO 14971). There was no clinical or pathological ground truth used as no clinical studies were performed.
8. The sample size for the training set:
- Not applicable. This is a software management system, not a machine learning model that typically involves a "training set" in the AI/ML sense.
9. How the ground truth for the training set was established:
- Not applicable, as no training set (in the AI/ML context) was described.
§ 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.