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Whole body Computed Tomography applications and specifically for interventional procedures that are performed on the CT table.

The CT Scope option is an addition to the CT Twin and HeliCAT families of CT . scanners. It comprises of hardware and software for initiation and termination of the scan process and for on-line monitoring of the resulting images in the gantry room, in addition to the Operator Console. Exposure is initiated by one of two pedals near the patient table and terminated by releasing the pedal. Partially reconstructed images are displayed at a rate of 6 images/second with a delay of approximately one second and displayed on a monitor in the scanner room. A handle for holding the needle from outside the direct radiation to reduce the dose received by the doctor during the interventional procedure is also included. The optional LaserGuide may be used for marking the entrance point and angle . of needle insertion externally to the gantry opening for convenience.

The provided text (K974344) describes a 510(k) submission for a “CT Scope option for CT scanners.” This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, much of the requested information regarding specific acceptance criteria demonstration and study details is not available within this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Reason for "Not explicitly stated": The document is a 510(k) summary, which typically focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting de novo clinical trial data with specific performance endpoints and acceptance criteria in the way a PMA (Premarket Approval) might. The "performance" stated here is about fulfilling system specifications and complying with regulations, not clinical accuracy or diagnostic performance.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided.
The document does not describe a "test set" in the context of clinical or performance data for an AI/algorithm-based device. The evaluation is focused on engineering verification and validation (that specs are met) and regulatory compliance.

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

Not applicable/Not provided.
No ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable/Not provided.
No test set adjudication method is described.

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

Not applicable/Not provided.
This document describes a CT system option, not an AI or algorithm-based diagnostic tool that would typically undergo an MRMC study.

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

Not applicable/Not provided.
This is not an AI/algorithm-only device. It's an enhancement for existing CT scanners.

7. The type of ground truth used

Not applicable/Not provided.
No "ground truth" in the context of clinical accuracy or diagnostic performance is mentioned. The ground truth for engineering validation would be the functional specifications and regulatory standards.

8. The sample size for the training set

Not applicable/Not provided.
No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable/Not provided.
No training set ground truth establishment is described.

Summary of the K974344 Document's Approach:

The K974344 submission is a 510(k) Premarket Notification for a CT Scope option. Its primary goal is to demonstrate substantial equivalence to predicate devices already on the market (CT-Twin flash, HeliCAT CT scanner, other interventional CT systems).

The evidence provided focuses on:

• Compliance with general controls: GMP practices, International Standards (IEC 601-1), and FDA regulations (21 CFR, Subchapter J performance standards).
• Hazard analysis and control: Identifying potential hazards and demonstrating how they are managed (e.g., software assurance procedures, quality assurance).
• Functional requirements: Stating that the option's specifications and functional requirements were met during internal testing (though no specific test results or data are presented in the summary).

The FDA's response confirms that the device is substantially equivalent for its stated indications for use (whole body CT applications and interventional procedures), meaning it is considered as safe and effective as the predicate devices without requiring a full clinical trial for novel performance claims.

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