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The SCENARIA Whole-body X-ray CT System with guideShot Option is a x-ray imaging device that produce cross-sectional images of the body at different angles. The system reconstructs, processes, displays, and stores the collected images. The guideShot Option adds a remote inroom display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

The SCENARIA Whole-body X-ray CT System is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The quideShot 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) premarket notification for the "guideShot Option, SCENARIA Whole-body X-ray CT System." The core of the submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance criteria against a clinical ground truth.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size or data provenance for human-read images or clinical studies. The performance comparison mentioned is based on non-clinical evaluations of physical and image quality characteristics, comparing the new device to its predicate. These evaluations are likely performed in a controlled lab setting using phantoms or test objects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The performance evaluation was primarily non-clinical, comparing technical specifications to a predicate device. Clinical ground truth, derived from expert consensus on patient images, would not be directly relevant to the described testing.

4. Adjudication Method for the Test Set

This information is not provided. Given the non-clinical nature of the performance evaluations, an adjudication method for clinical ground truth would not be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or described in this submission. The document focuses on technological and physical equivalence to a predicate device, not on demonstrating improved human reader performance with the new device or any AI assistance (which is not part of this device).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm-only performance study was not done or described. The device is a CT imaging system with an add-on option for remote in-room display and controls. It does not appear to incorporate an AI algorithm that would have standalone performance in interpreting images.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluations was based on physical and technical measurements of image quality (e.g., dose, noise, MTF, slice thickness) against established specifications or comparisons to the predicate device's measured performance. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the evaluations described.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a CT scanner, not a machine learning algorithm that requires a training set in the conventional sense. The "guideShot Option" is a hardware/software addition for remote control and display during interventional procedures.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reasons as point 8.

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