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Advantage Sim 6.0 is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning.

Anatomical volumes can be defined in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage.

Defined anatomical structures and geometric treatments fields are displayed on transverse CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye's view display with or without the display of defined structures with or without the display of digittaly reconstructed radiograph.

Advantage Sim 6.0. is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning.

Anatomical volumes can be defined in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. The geometric parameters of a proposed treatment field are selected to allow nondosimetric, interactive optimization of field coverage.

Defined anatomical structures and geometric treatments fields are displayed on transverse CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye's view display of defined structures with or without the display of defined structures with or without the display of digittaly reconstructed radiograph.

The GE Advantage Sim 6.0 has to ensure relations with the following external systems:

Data Export: Image, volume and plan data are exported in accordance with DICOM V3.0.

RT Data Import: Image, volume and plan data can be imported in accordance with the RT objects of the DICOM Standard.

Hardcopy: Hardcopy of all displays and plan data can be made at selected magnification on paper or transparency material. Users can print DRR to film at user defined SID if equipped with an Advantage Workstation 6.0. compatible Laser camera, with the appropriate AW Laser Camera Interface. Hardcopy of beam parameters and of isocenter coordinates, using IEC standard, can be made on an optional Postscript printer.

Archiving: Advantage Sim 6.0 can save DICOM images and DICOM RT objects on single-session DICOM CD R using an optional CD ROM writer.

Configuration Requirements: Advantage Sim 6.0 can be installed only on validated Advantage Workstation with single or dual color monitor.

The provided text is a 510(k) summary for the Advantage Sim 6.0 device, a radiation therapy simulation system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Advantage Sim 1.2) rather than presenting a performance study with detailed acceptance criteria and results for the new device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods for a standalone performance study are not explicitly described in this document. The document primarily relies on comparing the new device's functionality to existing, legally marketed predicate devices to establish safety and effectiveness.

Here's a breakdown of what can be extracted and what is not available from the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the format of acceptance criteria and device performance results. The document states:

• "Advantage Sim 6.0 provides images comparable to the predicate device."
• "Both of Advantage Sim 6.0 and Advantage Sim 1.2 provides complete volume definition and geometric beam placement capability for radiotherapy. It is then able to compute a DRR for any type of patient set-up and fully replaces a classic simulator."

These statements serve as qualitative assessments of performance and equivalence rather than quantifiable acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document makes no mention of a specific test set or data used for a performance study.

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)

This information is not provided. There is no mention of experts or ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. As there's no described test set or expert review, no adjudication method is mentioned.

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

A MRMC comparative effectiveness study is not mentioned. This device is a simulation system, not an AI-assisted diagnostic or workflow tool for human readers in the context of improving their performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study with specific metrics is not explicitly described. The document focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving novel performance against specific quantitative criteria. The statements about "comparable images" and "complete volume definition" imply functionality but not a formal standalone study with performance metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. Since no specific performance study creating ground truth is described, this detail is absent.

8. The sample size for the training set

This information is not provided. There is no mention of a training set as this is not an AI/ML device that requires training data in the modern sense.

9. How the ground truth for the training set was established

This information is not provided, as no training set or its ground truth establishment is mentioned.

In summary:

The provided 510(k) summary for the Advantage Sim 6.0 primarily focuses on demonstrating substantial equivalence to a predicate device (Advantage Sim 1.2) by comparing its intended use and functionality. It states that "Advantage Sim 6.0 provides images comparable to the predicate device" and details its capabilities for "complete volume definition and geometric beam placement." However, it does not contain the details of a specific performance study with quantifiable acceptance criteria, sample sizes, expert qualifications, or ground truth methods that would be typically associated with proving a device meets detailed acceptance criteria through a formalized study. The document emphasizes risk management, software development/validation, and verification plans as part of ensuring safety and effectiveness.

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