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The NeuViz Spiral CT Scanner System is intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.

The NeuViz Spiral CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.

The provided document is a 510(k) summary for the NeuViz Spiral CT Scanner System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information regarding acceptance criteria, device performance, a specific study proving it meets acceptance criteria, or most of the requested details about clinical trials or ground truth establishment.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: Not explicitly stated in terms of specific metrics or numerical performance. The document only mentions that "The device has been evaluated for performance, biocompatibility and effectiveness... and has been found to substantially equivalent to predicate device."

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

• The document explicitly states: "No clinical tests conducted." Therefore, there is no test set, sample size, or data provenance information.

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)

• As no clinical tests were conducted, there is no information about experts or ground truth establishment for a test set.

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

• As no clinical tests were conducted, there is no adjudication method 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 MRMC study was done, as explicitly stated: "No clinical tests conducted." This device is a CT scanner, not an AI-assisted reading device, so this type of study would not be applicable in this context.

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

• This question is not applicable. The device is a CT scanner system, not a standalone algorithm for diagnosis. The performance evaluation was against a predicate device for "performance, safety & effectiveness requirements."

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

• As no clinical tests were conducted, no ground truth was established for "clinical" performance. The evaluation was based on non-clinical tests demonstrating substantial equivalence to a predicate device.

8. The sample size for the training set

• No training set is mentioned as no clinical studies were performed. The device's substantial equivalence is based on its similarity to an existing device and non-clinical evaluations.

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

• As no clinical tests or training sets were mentioned, this information is not provided.

Summary of available information related to acceptance criteria and study:

The device (NeuViz Spiral CT Scanner System) obtained 510(k) clearance by demonstrating substantial equivalence to a predicate device (NeuViz Dual Multi-slice CT Scanner System (K071308)).

• Acceptance Criteria (Implicit): The implicit acceptance criterion for this 510(k) pathway was to demonstrate that the new device is as safe and effective as the predicate device. This is primarily established through non-clinical evaluations.
• Study Proving Acceptance Criteria (Non-clinical):
  • Type of Study: Non-clinical tests were conducted to evaluate "performance, biocompatibility and effectiveness as well as electdical, mechanical, chemical, biological, and radiation safety."
  • Conclusion: These non-clinical tests led to the conclusion that the device is "substantially equivalent to predicate device."
  • No Clinical Tests: The document explicitly states, "No clinical tests conducted."
  • Quality Systems: The manufacturer's design and development process conforms to 21 CFR part 820, ISO 9001, and ISO 13485 quality systems.

In essence, this 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, rather than detailed performance metrics from a clinical study with acceptance criteria.

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