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The HiSpeed QX/i CT Scanner System is indicated for head and whole body x-ray computed tomography applications.

The HiSpeed QX/i CT Scanner System consists of a gantry, patient table, console, computer and associated accessories. The System is designed to be a head and whole body CT scanner utilizing a solid state detector, and an intuitive Operator Console with the same tube and similar features to the HiSpeed CT/i with WarpScan and Performix Tube Options (K964746).

The provided 510(k) summary for the GE Medical Systems HiSpeed QX/i CT Scanner System does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.

The document is a premarket notification for a traditional CT scanner, not an AI or software-as-a-medical-device (SaMD) product that would typically undergo such rigorous performance validation against specific acceptance criteria for diagnostic accuracy. For traditional imaging devices like CT scanners, the "acceptance criteria" are generally related to demonstrating substantial equivalence to a predicate device in terms of technical specifications, safety, and intended use, rather than diagnostic accuracy metrics like sensitivity or specificity for a particular condition.

Here's a breakdown of what is available and what is missing based on your request:

What is present in the document:

• Device Identification: HiSpeed QX/i CT Scanner System.
• Intended Use: Head and whole body x-ray computed tomography applications.
• Comparison to Predicate: The device is stated to be "substantially equivalent to currently marketed Computed Tomography X-ray Systems" in terms of design, material composition, energy source, and radiation characteristics. The predicate device mentioned is the HiSpeed CT/i (K940606) and the HiSpeed CT/i with WarpScan and Performix Tube Options (K964746).
• Safety Standards: Compliance with UL 187, IEC 601-1, and 21 CFR Subchapter J (for x-ray requirements) is mentioned.
• Conclusion: "Use of the HiSpeed QX/i CT Scanner System does not result in any new potential safety risks and performs as well as or better than devices currently on the market."

What is missing entirely from the document, as it pertains to your specific request:

1. Table of Acceptance Criteria and Reported Device Performance (Diagnostic Accuracy): No such table exists. The document focuses on technical equivalence and safety standards, not performance metrics like sensitivity, specificity, or AUC against a ground truth for a diagnostic task.
2. Sample Size and Data Provenance for Test Set: Not applicable/not reported. There's no "test set" in the context of diagnostic accuracy for this type of submission. Performance is assessed against technical specifications and safety standards.
3. Number and Qualifications of Experts for Ground Truth: Not applicable/not reported. Ground truth in the diagnostic sense is not established or discussed for this CT scanner.
4. Adjudication Method for Test Set: Not applicable/not reported.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned as this is a CT scanner, not an AI-based diagnostic aid that enhances human reader performance.
6. Standalone Performance Study (Algorithm Only): Not applicable, as this is a physical CT scanner, not an algorithm.
7. Type of Ground Truth Used: Not applicable. For a CT scanner, "ground truth" relates to its physical performance (e.g., image resolution, dose, mechanical stability) rather than diagnostic accuracy on patient cases.
8. Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
9. How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided 510(k) pertains to a traditional CT scanner's substantial equivalence to predicate devices, focusing on safety and technical performance, rather than clinical diagnostic accuracy demonstrated through studies with acceptance criteria as typically seen for AI/ML medical devices.

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