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The ARIA Radiation Therapy Management product is a treatment 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 Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

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 the network using DICOM, the available image import filters or by means of film digitizers.

The Varian Eclipse™ Treatment Planning System (Eclipse TPS) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. Eclipse TPS is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation (brachytherapy) treatments.

The provided text describes a 510(k) premarket notification for two medical devices: ARIA Radiation Therapy Management (v15.8) and Eclipse Treatment Planning System (v15.8).

Based on the provided text, the following information can be extracted:

• Acceptance Criteria and Device Performance: The document states that the devices were "verified and validated according to the FDA Quality System Regulation (21 CFR §820) and other FDA recognized consensus standards." It also mentions, "Test results demonstrate that the device conforms to design specifications and meets of the intended users, including assuring risk mitigations were implemented and functioned properly."
  However, the document does not provide a specific table of acceptance criteria with reported numerical device performance metrics. The performance assessment is general, confirming adherence to regulatory standards and design specifications rather than specific quantitative thresholds for accuracy, sensitivity, specificity, or other performance indicators typical for AI/ML-driven devices.

• Study That Proves the Device Meets Acceptance Criteria:
  The study that proves the device meets the acceptance criteria is Software Verification and Validation Testing.

Here's a breakdown of the specific points requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria: The acceptance criteria are broadly defined as conformance to design specifications, meeting intended user requirements, and assuring risk mitigations were implemented and functioned properly. This is according to FDA Quality System Regulation (21 CFR §820) and other FDA recognized consensus standards (listed below).
* Reported Device Performance: "Test results demonstrate that the device conforms to design specifications and meets of the intended users, including assuring risk mitigations were implemented and functioned properly." No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity values) are provided for a direct comparison in a table format.

2. Sample size used for the test set and the data provenance:
* Sample Size: The document does not specify the sample size (e.g., number of cases or patients) used for the software verification and validation testing.
* Data Provenance: The document does not mention the country of origin of the data, nor does it specify if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This information is not provided. The document primarily focuses on software engineering and regulatory compliance rather than clinical performance validation involving experts establishing ground truth for a test set.

4. Adjudication method for the test set:
* This information is not provided. There's no mention of a clinical test set requiring adjudication in the context of this submission.

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 comparative effectiveness study was done. The document explicitly states: "No data from animal studies or clinical tests have been included in this pre-market submission." This indicates that the regulatory submission primarily relies on software verification and validation and comparison to predicate devices, not studies demonstrating human reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* The document implies that standalone software verification and validation testing was done, as it states "Software Verification and Validation Testing" was performed to ensure conformance to design specifications and risk mitigation. However, it does not explicitly detail "algorithm only" performance metrics in a clinical sense. The devices are described as tools for trained medical professionals, suggesting a human-in-the-loop operation, but the provided V&V is on the software itself.

7. The type of ground truth used:
* The term "ground truth" in a clinical performance context is not explicitly mentioned. For software verification and validation, ground truth would relate to the correctness of the software's output against its design specifications and expected behavior, rather than clinical outcomes or expert consensus on medical images.

8. The sample size for the training set:
* This information is not applicable and therefore not provided. These devices are not described as AI/ML systems that undergo a machine learning training phase on a dataset. They are software tools for treatment planning and management.

9. How the ground truth for the training set was established:
* This information is not applicable and therefore not provided, as these are not AI/ML training data sets.

In summary, the provided document focuses on regulatory compliance through software verification and validation and substantial equivalence to predicate devices, rather than detailed clinical performance studies often associated with novel AI/ML device submissions. The "acceptance criteria" are compliance with quality system regulations and standards, and "performance" is demonstrated by successful verification and validation tests against design specifications.

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