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The Slice Editor Imaging Software Utility is an image manipulation and eontouring software package for use in surgical and treatment planning. The Slice Editor can replace the IMEX contouring utility as the component for contouring anatomes in all applications in which IMEX is currently utilized.

The "Slice Editor" utility. It is an upgraded version of software intended for use in with surgical and treatment planning svstems where a graphical editing facility is used to create and modify anatomical structures. The common name is image editing software and its classification name is Stereotaxic instrument (accessory/utility).

The provided text is a 510(k) summary and related FDA correspondence for the "Slice Editor" imaging software utility. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

Specifically, the document states:

• Device Name: Slice Editor utility
• Intended Use: An upgraded version of software intended for use with surgical and treatment planning systems where a graphical editing facility is used to create and modify anatomical structures. It serves as an image manipulation and contouring package for use with existing and new RSA applications.
• Predicate Devices: IMEX software used in Radionics' XPlan-1 (K972905) and StereoPlan (K946252).
• Technological Characteristics: "The technological characteristics are the same or similar to those found with the predicate devices where contouring sessions generate anatomical data to assist in the treatment planning process."

The 510(k) process for this device relies on substantial equivalence to previously cleared predicate devices. This means the manufacturer demonstrated that the Slice Editor is as safe and effective as the predicate devices, often by showing it has the same or similar technological characteristics and indications for use. This typically does not involve presenting a new study with specific acceptance criteria, as would be expected for a novel device or a device making new claims.

Therefore, I cannot provide the requested information from the provided text for the following reasons:

1. Acceptance Criteria and Reported Device Performance: The document does not define any specific acceptance criteria for performance metrics, nor does it report any performance data (e.g., accuracy, precision, speed of contouring) for the Slice Editor.
2. Study Information (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): As there is no study described that establishes performance against defined acceptance criteria, none of these details are present in the provided text. The submission focuses on demonstrating substantial equivalence based on the device's functional similarity to existing cleared devices.

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