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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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The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes.

The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.

Volume datasets acquired by the Scenaria can be transferred to external devices via a DICOM standard interface.

The SCENARIA is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The SCENARIA system uses 64-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 64 slices of data simultaneously. The X-ray sub-system features a high frequency generator, X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles. The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system. The SCENARIA system consists of a Gantry, Operator's Workstation. Patient Table, high-Frequency X-ray Generator, and accessories.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Preamble: The provided document is a 510(k) summary for the HITACHI SCENARIA Whole-body X-ray CT System (K101888). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive novel clinical trials. Therefore, the "acceptance criteria" discussed are primarily about matching or demonstrating comparable performance to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The primary study proving these criteria is a "clinical evaluation comparison" and "bench testing."

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

• Sample Size for Test Set: The document does not specify a sample size for the clinical evaluation comparison. It simply states "A clinical evaluation comparison was conducted." For bench testing, it refers to "evaluations were conducted" for various physical and performance characteristics, but again, no specific sample sizes for tests are given.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) submission focusing on substantial equivalence to an existing device, it's possible that the "clinical evaluation comparison" involved comparing image quality or diagnostic utility, but the details are not provided.

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

• The document does not mention using experts to establish ground truth in the context of the clinical evaluation. As this is a comparison study against a predicate device, the "ground truth" implicitly would be the established diagnostic capabilities of the predicate device. The study seems to rely on demonstrating comparable imaging performance rather than an independent diagnostic accuracy assessment against a definitive ground truth.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method (e.g., 2+1, 3+1). This implies that such a process was either not part of the comparative evaluation or not deemed necessary for a 510(k) submission where the primary goal is substantial equivalence rather than establishing new diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a CT scanner, not an AI-assisted diagnostic tool. The comparison is between two CT systems.

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

• Not applicable. This device is a CT scanner, which inherently involves human operation and interpretation. It is not an algorithm for standalone diagnosis.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The document does not explicitly state a specific type of ground truth was used beyond the implicit "performance characteristics of the SCENARIA are comparable to the predicate device." For a medical imaging device, the ultimate ground truth would typically involve pathology, clinical outcomes, or follow-up, but the 510(k) focusses on demonstrating equivalent imaging capabilities and safety without explicitly stating how diagnostic accuracy against a definitive ground truth was established. The clinical evaluation likely focused on qualitative assessment of image quality and diagnostic interpretability relative to the predicate.

8. The Sample Size for the Training Set

• Not applicable. This is a hardware device (CT scanner), not a machine learning algorithm that requires a training set.

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

• Not applicable. (See point 8).

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