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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.

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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:

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.

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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 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 describes the ARIA Radiation Therapy Management (v16.1 MR3) device, which is a treatment plan and image management application. It states that the device was cleared based on non-clinical testing and refers to software verification and validation as the primary performance data.

However, the text does not contain the specific information requested regarding acceptance criteria, reported device performance, details of a study (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case (MRMC) comparative effectiveness study, standalone performance, or ground truth details for testing and training sets.

The document states:

• "No data from animal studies or clinical tests have been included in this pre-market submission."
• "Since the predicate device was cleared based only on the results of non-clinical testing, no animal or clinical studies were conducted for the subject device. 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."

Therefore, I cannot provide the requested information from the given text. The provided document focuses on regulatory compliance, outlining the device's intended use, comparison with a predicate device, and adherence to software verification and validation testing and various regulatory standards (e.g., IEC 62304, ISO 13485, ISO 14971).

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

The provided document is a 510(k) summary for Varian Medical Systems, Inc.'s ARIA Radiation Therapy Management 15.5 MR1. This product is a management application for radiation therapy treatment plans and images, not a diagnostic or AI-powered device that identifies or predicts conditions. Therefore, it does not involve acceptance criteria, performance metrics, ground truth establishment, or clinical studies of the type typically associated with AI-driven medical devices (e.g., sensitivity, specificity, reader studies).

The document focuses on "Software Verification and Validation Testing" and "Standards conformance" to demonstrate the safety and effectiveness of the device as a management system. The "Summary of Performance Data" section explicitly states: "No clinical tests have been included in this pre-market submission."

Given this, I cannot provide the requested information. The questions you've asked are not applicable to the type of device and submission described in the provided text.

Ask a specific question about this device

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

After reviewing the provided FDA 510(k) summary for "ARIA Radiation Therapy Management," it appears that the document describes a software application for managing radiation therapy data and images, rather than an AI-powered diagnostic or assistive device that would typically undergo rigorous performance studies with specific acceptance criteria, test sets, and ground truth establishment involving expert readers.

The provided text focuses on:

• Device Description and Intended Use: Managing, storing, accessing, and modifying treatment plan and image data, and storing treatment histories.
• Changes to Predicate Device: Listing minor software feature changes, such as improved rigid registration, DICOM UI, and workflow usability.
• Summary of Performance: A generic statement that "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards testing: functioned properly."
• Standards Conformance: Listing relevant IEC standards (e.g., IEC 61217, IEC 62366, IEC 62304).

Crucially, there is no mention of:

• Specific acceptance criteria tied to a particular performance metric (e.g., sensitivity, specificity, accuracy).
• A test set size, data provenance, or details of a study involving human readers or AI performance evaluation.
• Ground truth establishment methods, expert qualifications, or adjudication.
• MRMC studies or standalone algorithm performance.

It seems this device falls under a category where conformance to software engineering standards, functionality testing, and verification/validation against specifications are the primary means of demonstrating safety and effectiveness, rather than a clinical performance study with statistical endpoints. The changes are primarily software enhancements and re-structuring, not the introduction of a new AI algorithm for detection, diagnosis, or prediction that would require such studies.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies in the format you've outlined because the provided document does not contain that level of detail for this specific type of device and its claimed modifications.

To answer your request based only on the provided text, the response would be:

Based on the provided FDA 510(k) summary for ARIA Radiation Therapy Management (K133572), the device is a treatment plan and image management application, and the submission primarily addresses software modifications and functional capabilities, not a new AI-powered diagnostic or assistive feature that would necessitate a clinical performance study with specific acceptance criteria measured against a defined test set.

Therefore, the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not present within this document.

The document broadly states:

1. A table of acceptance criteria and the reported device performance: This information is not provided in a quantifiable table format. The summary states: "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards testing: functioned properly." This implies the acceptance criteria were likely functional and performance specifications related to data management, accessibility, storage, and processing, rather than clinical efficacy metrics.
2. Sample sized used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified, as ground truth in the context of clinical interpretation/diagnosis is not relevant for this device's modifications.
4. Adjudication method for the test set: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not specified. It is highly unlikely for this type of software management system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not specified.
7. The type of ground truth used: Not specified, given the device's function.
8. The sample size for the training set: Not specified. (This device is not described as involving machine learning training.)
9. How the ground truth for the training set was established: Not applicable, as no machine learning training is described.

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