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The CXR4 Computed Tomography System with guideShot Option are x-ray imaging devices that produce cross-sectional images of the body at different angles. The systems reconstruct, process, display, and store the collected images. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

The CXR4 and ECLOS is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The guideShot Option adds a remote monitor and controls at the patient table to allow the operator to initiate data collection and to view resulting CT images in order to support interventional procedures.

The provided text describes a 510(k) submission for the Hitachi guideShot Option for CXR4 and ECLOS Computed Tomography X-ray Systems. This submission is for a device that adds remote display and controls to existing CT systems to support interventional imaging. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a standalone performance study with comprehensive acceptance criteria and detailed clinical trial results for the guideShot Option itself.

Therefore, many of the requested elements for a detailed acceptance criteria study are not explicitly described in the provided 510(k) summary. The document focuses on comparing the performance characteristics of the new system with its predicate device to show technological equivalence.

Here's an attempt to answer the questions based only on the provided text, noting where information is not available:

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

The document does not present a formal table of acceptance criteria with corresponding performance metrics for the guideShot Option as a distinct new device requiring such a study. Instead, it claims substantial equivalence based on the underlying CT systems and the similarity of the performance characteristics.

The "acceptance criteria" for the guideShot Option, as implied, were that its integration and new features (remote display and controls) do not degrade the performance of the core CT system and that its output is comparable to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not explicitly stated. The evaluation was "non-clinical" and involved measurements on the device itself, rather than a "test set" of patient data in the typical sense.
• Data provenance: Not specified. Given it's non-clinical, it would be laboratory/engineering data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this was a non-clinical evaluation of the system's physical and performance characteristics, not a diagnostic accuracy study requiring expert human interpretation or ground truth establishment from patient cases.

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

Not applicable, as there was no clinical test set requiring adjudication.

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 such study was conducted or reported. The device is an imaging system, not an AI-assisted diagnostic tool.

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

This refers to the performance of the CT system itself. The document states that the CXR4 and ECLOS systems (which the guideShot option integrates with) were subjected to non-clinical evaluations to confirm their performance characteristics. These would be "standalone" in the sense of the machine's inherent imaging capabilities. The guideShot Option's performance is described as being "similar" and "comparable" to the predicate, implying these standalone characteristics were maintained.

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

For the non-clinical evaluations mentioned (dose profile, image noise, MTF, etc.), the "ground truth" would be established by physical measurements and engineering specifications, often against standardized phantoms or reference systems, rather than clinical outcomes or pathology.

8. The sample size for the training set

Not applicable. This device does not use machine learning in a way that requires a "training set" in the conventional sense for image analysis or diagnostic output.

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

Not applicable.

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