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To detect or image the distribution of radionuclides in the body or organ, using the following techniques:

• Multiplanar Reconstruction (MPR) .
• Maximum/Minimum Intensity Projection (MIP) .
• Image Contrast Manipulation .
• Image Zoom Manipulation .
• Automatic registration with Mutual Information Technique .

Clarity PET is PET intage review software. Clarity PET offers a comprehensive software solution for medical imaging tasks and applications. Clarity PET is a medical diagnostic workstation designed for display, review, 3D MPR, communication and archiving of medical images

This 510(k) submission (K032866) for the Clarity PET device does not contain a study demonstrating that the device meets specific acceptance criteria based on its performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance metrics in the provided document. The submission relies on establishing equivalency rather than meeting new performance benchmarks.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No new performance study (test set, data provenance) is conducted for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. No new performance study is conducted that involved establishing ground truth with experts.

4. Adjudication Method:

Not applicable. No new performance study requiring adjudication is conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The submission does not present a study comparing human reader performance with and without AI assistance, as the device is image review software, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study was not done. The Clarity PET is described as image review software and thus its "performance" is implicitly tied to its ability to display and manipulate images, similar to predicate devices. It's not an algorithm providing a diagnostic output independently.

7. Type of Ground Truth Used:

Not applicable. No ground truth for a new performance study is established or used in this submission.

8. Sample Size for the Training Set:

Not applicable. The provided document does not describe a training set for an algorithm, as the device is image review software, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of the K032866 Submission's Approach:

The K032866 submission for Clarity PET establishes substantial equivalence by demonstrating:

• Equivalent Indications for Use: The device can "detect or image the distribution of radionuclides in the body or organ, using the following techniques: Multiplanar Reconstruction (MPR), Maximum/Minimum Intensity Projection (MIP), Image Contrast Manipulation, Image Zoom Manipulation, Automatic registration with Mutual Information Technique." These are explicitly stated as equivalent to the Medical Image Merge™ device.
• Equivalent Technological Characteristics, Performance Characteristics, and Instructions for Use: The submission asserts that Clarity PET shares these equivalencies with the Medical Image Merge™ device and other predicate devices like Syngo Multi-Modality Workstation, ADAC Laboratories Image Fusion and Review System, and GE Advantage Windows Workstation.

The core of this 510(k) is a comparison to legally marketed predicate devices, asserting that Clarity PET performs the "same functions" and has "equivalent" characteristics, rather than providing new performance data against a specific set of acceptance criteria. The FDA's letter confirms that they reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.

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