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The LightSpeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications.

The GE LightSpeed 5.0 CT Scanner System is composed of a gantry, patient table, image acquisition hardware and software, an operator console, and associated accessories. Materials and construction are equivalent to the LightSpeed 4.0 CT Scanner System and are compliant with UL2601-1. IEC 60601-1 and associated collateral and particular standards, and applicable sections of 21 CFR Subchapter J.

The provided document is a 510(k) Premarket Notification for the GE LightSpeed 5.0 CT System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, and expert adjudication is not present in this document.

This submission states: "The GE LightSpeed 5.0 Computed Tomography System is a modification of, and of comparable type and substantially equivalent to the currently marketed GE LightSpeed 4.0 (aka LightSpeed®) CT System. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended use as the predicate device."

The study summarized is focused on safety and compliance, not performance.

Here's a breakdown of what can be extracted and what is not available based on your request:

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

• Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criteria are related to being "substantially equivalent" in safety and effectiveness to the predicate device (LightSpeed 4.0 CT System) and conforming to applicable standards. The document mentions compliance with UL2601-1, IEC 60601-1, associated collateral and particular standards, and applicable sections of 21 CFR Subchapter J.
• Reported Device Performance: No specific performance metrics (e.g., spatial resolution, contrast-to-noise ratio, dose reduction) are reported for comparison against quantitative acceptance criteria. The document only states that the device "has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards."

2. Sample size used for the test set and the data provenance

• Not Applicable. This submission does not describe a clinical performance study with a test set of patient data to assess diagnostic accuracy or similar performance metrics. The evaluation was for electrical, mechanical, and radiation safety, and standards conformance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. As no clinical performance study on a test set (e.g., imaging data) is described, there is no mention of experts or ground truth establishment in this context.

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

• Not Applicable. No clinical performance study on a test set requiring adjudication is described.

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

• No. This is a CT scanner system, not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.

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

• No. This is a CT scanner, not an algorithm.

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

• Not Applicable. For the safety and standards conformance evaluation, the "ground truth" would be the specifications and requirements of the relevant safety and performance standards.

8. The sample size for the training set

• Not Applicable. This is a hardware system, not a software algorithm that requires a training set.

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

• Not Applicable. (See point 8)

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