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The FCT iStream system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The FCT iStream system can also be used for interventional needle guidance. Volume datasets acquired by an FCT iStream system can be post-processed in the FCT iStream system to provide additional information. Post-processing capabilities of the FCT iStream software include multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by an FCT iStream system can be transferred to external devices via a DICOM standard interface.

The Low Dose CT Lung Cancer Screening Option for the FCT iStream system is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or FUJIFILM Healthcare Corporation.

Device Description

The FCT iStream is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The FCT iStream X-ray source is designed to enable the continuous emission of fan-beam Xrays, and the solid state detector unit is positioned opposite the X-ray source to measure the intensity distribution of the X-rays. The total number of detector channels is 888 channels x 64 rows, and all of the rows are used as 64-slice portions. 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 FCT iStream system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.

AI/ML Overview

This appears to be a 510(k) premarket notification summary for a Computed Tomography (CT) system (FCT iStream Phase 1) seeking substantial equivalence to a predicate device (SCENARIA View 4.2). The document primarily focuses on demonstrating the new device's equivalence to an existing one, rather than presenting a detailed study proving novel performance in terms of AI assistance or diagnostic improvement.

Therefore, many of the specific details requested in your prompt (e.g., number of experts for ground truth, MRMC study, effect size of AI assistance, stand-alone performance, training set details) are not typically found or required in a 510(k) submission for a CT scanner that is not inherently an AI/CADe device. The focus here is on the physical and performance characteristics of the CT scanner itself being comparable to a legally marketed predicate.

However, I can extract the relevant information regarding acceptance criteria and performance as presented in this document, inferring the study approach from the context of a 510(k) for a CT system.

Acceptance Criteria and Device Performance for FCT iStream Phase 1

Since this is a 510(k) for a CT system based on substantial equivalence, the "acceptance criteria" are implicitly and explicitly tied to demonstrating that the FCT iStream Phase 1 performs comparably to its predicate device (SCENARIA View 4.2) and adheres to relevant international standards. The "study" proving this largely involves bench testing against specified parameters and compliance with standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the FCT iStream Phase 1 has "equivalent basic performance as the predicate device" and that "the system performance is similar to the predicate device." Instead of specific numerical acceptance criteria for each item, the document lists tested parameters and confirms compliance or equivalence.

Parameter/Characteristic	Acceptance Criteria (Implied by 510(k) Substantial Equivalence and Standards)	Reported Device Performance
General Performance	Performance comparable to the predicate device (SCENARIA View 4.2), meeting intended use for whole-body CT imaging, including low-dose lung cancer screening.	"The system performance is similar to the predicate device."
"Evaluations were conducted for IntelliODM, iTilt and for features that were removed from the subject device to the predicate device... The evaluation results confirm the performance characteristics of FCT iStream are comparable to the predicate device and support our conclusion that the subject system is substantially equivalent."
Dose Profile	Meets conditions of 21 CFR 1020.33(c) or (g) and IEC61223-3-5 requirements.	"We confirmed that the items (Dose Profile... CT dose index) which we tested met the conditions of 21 CFR 1020.33(c) or (g)."
Noise	Meets conditions of 21 CFR 1020.33(c) or (g) and IEC61223-3-5 requirements.	"We confirmed that the items (...Noise...) which we tested met the conditions of 21 CFR 1020.33(c) or (g)."
Mean CT Number and Uniformity	Meets conditions of 21 CFR 1020.33(c) or (g) and IEC61223-3-5 requirements.	"We confirmed that the items (...Mean CT number and Uniformity...) which we tested met the conditions of 21 CFR 1020.33(c) or (g)."
Spatial Resolution	Meets conditions of 21 CFR 1020.33(c) or (g) and IEC61223-3-5 requirements.	"We confirmed that the items (...Spatial Resolution...) which we tested met the conditions of 21 CFR 1020.33(c) or (g)."
Tomographic Section Thickness and Sensitivity Profile	Meets conditions of 21 CFR 1020.33(c) or (g) and IEC61223-3-5 requirements.	"We confirmed that the items (...Tomographic Section Thickness and Sensitivity Profile...) which we tested met the conditions of 21 CFR 1020.33(c) or (g)."
Tomographic Plane Location	Meets conditions of 21 CFR 1020.33(c) or (g) and IEC61223-3-5 requirements.	"We confirmed that the items (...Tomographic Plane Location...) which we tested met the conditions of 21 CFR 1020.33(c) or (g)."
CT Dose Index	Meets conditions of 21 CFR 1020.33(c) or (g) and IEC61223-3-5 requirements.	"We confirmed that the items (...CT dose index) which we tested met the conditions of 21 CFR 1020.33(c) or (g)."
Gantry Tilt Mechanism	Equivalence in function to predicate device (achieved through iTilt software function).	"This gantry does not have a tilt mechanism compared to the predicate device. If it is necessary to take a tilted image, it will use the iTilt function to create an equivalent MPR image. So it will not affect the effectiveness of the system."
IntelliODM Feature	Effective reduction of X-ray exposure to the patient's head / sensitive organs, comparable to the predicate.	"IntelliODM is a feature that uses IntelliEC technology to reduce X-ray exposure from the patient's head, reducing direct radiation dose to sensitive organs." (Implicitly, it performs as intended for safety and comparable to predicate's dose control)
Safety and Electrical Standards	Compliance with AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-44, IEC 62304, NEMA XR 25.	"This device complies with all applicable requirements for... CT dose index."
"In addition, the FCT iStream Phase 1 is in conformance with the applicable parts of the following standards..." (all listed standards are confirmed).

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

Sample Size: The document does not specify a "sample size" in terms of patient cases for clinical evaluation, because the performance testing was primarily bench testing (phantom studies) rather than a clinical study with patient data.
Data Provenance: Not applicable as the "study" was bench testing. If patient data was used, its origin (country, retrospective/prospective) would be relevant.

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

Not applicable. For a CT system's core performance evaluation in a 510(k), ground truth is established through physical measurements using phantoms and established metrology standards (e.g., IEC61223-3-5), not by medical experts interpreting images.

4. Adjudication Method for the Test Set

Not applicable, as there was no expert interpretation or adjudication of patient images mentioned in the context of this 510(k) performance testing.

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, an MRMC comparative effectiveness study was not done as described. This submission is for a general CT system, not an AI/CADe device. The document does not report any AI-assisted human reader performance improvements.

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

Not applicable for a standalone diagnostic algorithm. This device is a CT scanner, which generates images for human interpretation. While it contains software (e.g., iTilt, IntelliODM), the performance discussed is of the imaging system itself, not a diagnostic algorithm meant to perform diagnosis or detection independently.

7. The Type of Ground Truth Used

The ground truth for the performance testing was established through physical phantom measurements and engineering specifications as outlined in the referenced IEC and NEMA standards (e.g., IEC61223-3-5, NEMA XR 25). For example, spatial resolution might be measured using a line pair phantom, noise using a water-equivalent phantom, and CT numbers using specific material inserts.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of a CT scanner's performance for 510(k) clearance, not the development or training of a machine learning or AI algorithm in the typical sense that would require a "training set" of clinical data. While the device contains software, the "training set" concept is not relevant to this type of regulatory submission for a CT system.

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

Not applicable. As a training set for an AI/ML algorithm is not described, the method for establishing its ground truth is also not.

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