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X-ray imaging of whole body - Computerized Tomography Including; Axial Volumetric (Helical) CT Fluoroscopy Respiratory (4D) Gated Scanning. Respiratory Gated (4D) Scanning on the Aquilion LB is a non-invasive software/hardware option that can be used for the evaluation of respiration-induced motion by acquiring and displaying CT images consisting of all respiratory phases during a breathing cycle.

The CKRS-003A Respiratory Gating Option will be added to the previously cleared TSX-201A Aquilion LB CT system. This addition requires hardware and software modifications to the existing device.

The provided text describes a 510(k) submission for a modification to a CT system, specifically adding a Respiratory Gating Option. However, it does not include a detailed study proving the device meets specific acceptance criteria with reported performance metrics. The document focuses on establishing substantial equivalence to predicate devices and adherence to regulatory standards rather than presenting a performance study with numerical results.

Therefore, many of the requested sections below cannot be fully completed based on the provided text.

Here's an attempt to answer based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given text. The document states that the device "will be met and reported via a supplement to the initial report for the predicate device" regarding performance standards, implying that detailed performance data would be in a separate, unprovided document.

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

This information is not provided in the given text. The document refers to meeting performance standards but does not detail any specific test set or data used for verification of the Respiratory Gating option.

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

This information is not provided in the given text. There is no mention of a test set, ground truth establishment, or expert involvement in the provided document.

4. Adjudication Method for the Test Set

This information is not provided in the given text. There is no mention of a test set or 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 in the given text. The device described, a CT system with respiratory gating, is a hardware/software modification to an imaging device, not an AI-assisted diagnostic tool for human readers in the way an MRMC study would typically evaluate. The primary change is to reduce motion artifacts and improve targeting, which indirectly aids human interpretation, but a formal MRMC study as described is not mentioned.

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

This information is not explicitly provided in the given text. The document describes the Respiratory Gating option as reducing motion artifacts and improving targeting. This implies an algorithmic process, but whether its performance was evaluated purely in a standalone manner (without any human interpretation of the resulting images) is not detailed. The focus is on the output of the images for clinical utility.

7. The Type of Ground Truth Used

This information is not provided in the given text.

8. The Sample Size for the Training Set

This information is not provided in the given text. There's no mention of a training set for the respiratory gating algorithm.

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

This information is not provided in the given text, as no training set is mentioned.

Summary of the Study (Based on Given Text):

The provided text details a 510(k) submission for the Toshiba TSX-201A Aquilion LB CT System with a new Respiratory Gating Option (CKRS-003A). The "study" presented in this document is primarily a regulatory submission aimed at demonstrating substantial equivalence to existing legally marketed devices.

The key points of this submission are:

• Predicate Devices: The device is being compared to the TSX-201A Aquilion LB CT (K050458) and the Varian RPM Respiratory Gating System (K983629).
• Reason for Submission: Modification of the cleared TSX-201A Aquilion LB CT system to include the Respiratory Gating Option.
• Intended Use: To produce cross-sectional images for various diagnoses, with the addition of respiratory gating to "reduce motion artifacts and improve targeting of anatomy for use with other cleared devices."
• Safety and Effectiveness Concerns: The device is designed and manufactured under Quality System Regulations (21 CFR § 820) and complies with Federal Diagnostic Equipment Standards (21 CFR § 1020.30 and 1020.33) and applicable IEC standards (60601-1, 60601-2-32, 60601-2-44).
• Claim of Substantial Equivalence: Toshiba America Medical Systems, Inc. believes the combination of the two predicate devices (the CT system and the respiratory gating system) does not change the intended use of either device.

Crucially, this document does not present specific performance data or a detailed study with acceptance criteria, sample sizes, expert ground truth establishment, or any statistical evaluation of the respiratory gating's performance against defined metrics. It primarily asserts compliance with regulatory standards and substantial equivalence, with detailed performance data implied to be in a "supplement to the initial report for the predicate device."

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This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no intended uses that are not in cleared devices already found in the marketplace.

X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy

The Aquilion LB is a multi-slice helical CT system, consisting of a gantry, patient couch and console. The system generates up to 32 axial slices per second using a selectable slice-thickness multi-row detector.

This document is a 510(k) Summary for the Toshiba Aquilion LB CT Scanner. It's a regulatory submission to the FDA to demonstrate substantial equivalence to a predicate device, not a performance study report with explicit acceptance criteria and device performance table. Therefore, much of the requested information regarding specific acceptance criteria and detailed study results is not present in this document.

However, based on the document's content, here's what can be inferred or stated about the device and its regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail metrics. The entire submission implies that the acceptance criterion is "substantial equivalence" to the predicate device (Aquilion MS-16 CT scanner, K022050) in terms of intended use, technological characteristics, and safety and effectiveness. This is achieved by demonstrating that the new device does not raise new questions of safety or effectiveness.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, image resolution values) are reported in this summary. The document states that the device is "designed to produce cross-sectional images of a human body by reconstruction of xray transmission data... These images have been proven to be clinically useful..." without providing quantitative performance data for this specific device model.

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

• Not Applicable / Not Provided: This document describes a regulatory submission for substantial equivalence based on technological characteristics and compliance with standards, not a clinical performance study with a test set of patient data.

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

• Not Applicable / Not Provided: No test set or ground truth establishment by experts is described in this regulatory summary.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided: No test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This document does not describe an MRMC comparative effectiveness study, nor does it mention AI assistance. This is a submission for a traditional CT scanner.

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

• No. This document pertains to a physical CT scanner, not an algorithm, and does not describe standalone performance testing as typically understood for AI/software devices.

7. The Type of Ground Truth Used:

• Not Applicable / Not Provided: Ground truth, in the context of clinical performance studies, is not described in this regulatory submission. The "truth" being established is that the device is substantially equivalent to a predicate, not clinical accuracy against a "ground truth" diagnosis.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided: As this is an application for a CT scanner and not an AI/ML device, a "training set" in that context is not relevant or mentioned.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable / Not Provided: See point 8.

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