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The Analogic CTXX85 systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 systems are indicated for pediatric and adult patients.

The CTXX85 is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are two models of the CTXX85 scanner: CT6485 (64 slice configuration) and CT12885 (128 slice configuration).

The CTXX85 CT Scanners includes LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution.

The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box).

Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder and QA phantom and mount.

The provided text describes a 510(k) premarket notification for the Analogic CT6485 and CT12885 Computed Tomography (CT) systems. It details the device, its intended use, comparison to predicate devices, and performance data to support substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not specify explicit "acceptance criteria" in a numerical or target performance metric for image quality. Instead, it refers to fulfilling requirements of various consensus standards and demonstrating performance comparable to predicate devices. The reported device performance is described qualitatively as meeting these standards and the images being of diagnostic quality.

2. Sample sized 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: The document mentions "sample clinical images of the brain, chest, abdomen and extremity," but does not specify the exact number of images or cases used in the clinical evaluation.
• Data Provenance: Not specified. It's unclear if the clinical images were retrospective or prospective, or their country of origin.

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

• Number of Experts: "a board-certified radiologist" (singular).
• Qualifications of Experts: "board-certified radiologist." No further details on years of experience or subspecialty.

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

• Adjudication Method: None specified. The text only states that a single board-certified radiologist evaluated the images.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. The study description focuses on confirming diagnostic quality by a single reader and benchmarking against physical phantom measurements.
• Effect Size: Not applicable, as no MRMC study was conducted.

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

• Standalone Performance: The non-clinical performance testing on phantom models directly assesses the algorithm's performance without human interpretation (e.g., MTF, low contrast detectability, noise, CT number accuracy). This can be considered a form of standalone performance evaluation for image quality metrics.
  • "Image Quality performance testing for the CTXX85 was conducted on standard phantom models to assess modulation transfer function (MTF), low contrast detectability, noise, CT number accuracy, CT uniformity, axial slice thickness, helical slice sensitivity profile, axial and helical image quality for head and body."
  • "Testing was conducted to evaluate image quality performance of the iterative reconstruction algorithm."

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

• Non-clinical (Image Quality): The ground truth for image quality metrics (MTF, noise, etc.) is established by the physical properties of the phantom models and expected system performance based on established engineering principles and physics.
• Clinical (Diagnostic Quality): For the clinical images, the ground truth was expert opinion/assessment by "a board-certified radiologist" confirming "diagnostic quality." This is a subjective assessment rather than a definitive ground truth like pathology.

8. The sample size for the training set

• Training Set Sample Size: Not specified. The document does not mention the training of the LISA algorithm or any other components, nor does it provide a sample size for a training set. The focus is on the performance of the device as a whole.

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

• Training Set Ground Truth: Not specified. Since the training set sample size and details of the training itself are not provided, how its ground truth was established is also not mentioned.

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