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The Mx8000 IDT is a Whole Body Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.

The Mx8000 IDT is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability of up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.

The provided text is a 510(k) Summary for the Marconi Medical Systems Inc. Mx8000 IDT CT Scanner. This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with detailed acceptance criteria and supporting data as might be found in a clinical trial report or a performance validation study for an AI/CAD device.

Based on the content provided, here's what can be extracted and what cannot:

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

This information is not provided in the document. The 510(k) summary for this CT scanner focuses on comparing it to predicate devices (Mx8000 K982060 and Mx8000 v5.0 K010817) and demonstrating substantial equivalence based on device description, intended use, and adherence to safety standards (GMP, IEC 60601-1, 21 CFR Subchapter J for radiation safety). There are no specific performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic task) or quantitative acceptance criteria listed.

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

This information is not provided. As this is a 510(k) for a CT scanner system and not a diagnostic algorithm or AI product, an independent performance test set with associated data provenance would not typically be part of this type of submission. The safety and effectiveness are established through adherence to standards and comparison to predicate hardware.

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):

This information is not provided. There is no mention of a test set requiring expert ground truth in this document.

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

This information is not provided. There is no mention of a test set, and therefore no adjudication method.

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:

This information is not provided. An MRMC study is relevant for AI-assisted diagnostic tools. This 510(k) is for a CT scanner hardware system, not an AI or CAD software, so such a study would not be expected or relevant here.

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

This information is not provided. This is not an AI algorithm.

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

This information is not provided. No specific ground truth methodology is mentioned as it's not relevant to this type of 510(k) submission for a CT scanner.

8. The sample size for the training set:

This information is not provided. This is not an AI/ML product, so there is no training set in the context of machine learning.

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

This information is not provided. Not applicable for this device.

Summary of what CAN be extracted:

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices (Mx8000 K982060 and Mx8000 v5.0 K010817) based on:

• Device Description: Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry, multi-slice capability (up to 16 slices simultaneously), and computer reconstruction of x-ray transmission data.
• Intended Use: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
• Safety and Effectiveness: Assured by adherence to GMP practices, company procedures for software safety, IEC 60601-1 for electrical and mechanical safety, and 21 CFR Subchapter J for radiation safety.

The acceptance criteria for this type of submission are primarily regulatory: demonstrating that the device is as safe and effective as a legally marketed predicate device, satisfying the requirements for general controls under the Federal Food, Drug, and Cosmetic Act. The "study" proving this is the 510(k) submission itself, where the manufacturer presents a detailed comparison to predicate devices and asserts compliance with relevant safety standards. No specific performance study with quantitative acceptance criteria and results as typically seen for diagnostic devices is described.

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