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The Brilliance CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

The dual energy option allows the system to acquire two CT images of the same anatomical location using two distinct tube voltages and/or tube currents during two tube rotations. The x-ray dose will be the sum of the doses of each tube rotation at its respective tube voltage and current. Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in x-ray attenuation between these distinct energies. This information may also be used to reconstruct images at multiple energies within the available spectrum, and to reconstruct basis images that allow the visualization and analysis of anatomical and pathological materials.

Philips Healthcare offers a Dual Energy scanning option on the Brilliance CT Scanner. The Brilliance Dual Energy option automates the execution of sequential scanning protocols acquired during the same episode of care using two unique tube voltages and/or currents. The acquired datasets can be displayed side-by-side or overlaid and then analyzed to augment the review of anatomical and pathological structures. Dual energy imaging, by nature of differing x-ray energy values, enables the identification of attenuation differences found in those structures between the two applied energies.

This submission K090462 for the Philips Medical Systems (Cleveland) Inc. Brilliance Dual Energy option does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

The document is a 510(k) Summary, which primarily focuses on establishing substantial equivalence to predicate devices and detailing the intended use. It does not typically include the specifics of performance studies, acceptance criteria, or ground truth establishment that would be found in a full submission or a clinical study report.

Based on the provided text:

• No specific acceptance criteria or a study demonstrating the device meets those criteria are explicitly reported. The document states that the device is "of comparable type and substantially equivalent to the legally marketed devices" (K060937 and K081105) based on "similar technological characteristics and subassemblies." This is a regulatory statement of equivalence, not a performance study result against stated acceptance criteria.

Therefore, I cannot populate the table or provide detailed answers to most of your questions based solely on the provided text.

However, I can extract information related to the device description and intended use:

1. Table of Acceptance Criteria and Reported Device Performance

Since the document does not describe a performance study with acceptance criteria, the following questions cannot be answered from the provided text:

• 2. Sample size used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method for the test set: Not mentioned.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, as this is an imaging option, not a standalone algorithm.
• 7. The type of ground truth used: Not mentioned.
• 8. The sample size for the training set: Not mentioned.
• 9. How the ground truth for the training set was established: Not mentioned.

Summary of what the document does provide:

• Device Name: Brilliance Dual Energy option
• Intended Use: To produce cross-sectional images using two distinct tube voltages and/or tube currents, aiding in material composition analysis, and reconstruction of images at multiple energies and basis images.
• Classification: Class II (21 CFR 892.1750, Product Code 90 JAK)
• Predicate Devices: Philips Brilliance Volume (K060937) and GE Lightspeed CT750 HD (K081105).
• Basis for Equivalence: Similar technological characteristics and subassemblies.

To obtain the detailed study information you're asking for, one would typically need access to the full 510(k) submission, not just the summary, or any publicly available performance reports or clinical studies related to this specific device option.

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