(27 days)
The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).
The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.
The CT-Guide System is comprised of four main components: (1) the ActiSensor, a disposable video camera that is mounted onto a holder, which is clipped to a needle: (2) the ActiSticker, a disposable pad, which provides visual and radio-opaque reference markers; (3) a workstation that contains a dedicated computer; and (4) accompanying computer software.
The CT-Guide Needle Guidance System underwent performance and accuracy testing through several bench tests conducted on a custom phantom setup. All results were reported as satisfactory and met predefined specifications. The CT-Guide modified software was validated and tested. Additionally, the system was retested for electromagnetic compatibility and electrical safety per IEC 60601-1 and IEC 60601-1-2. In all instances, the CT-Guide functioned as intended, and testing results were as expected. This submission is a Special 510(k) for modifications to a previously cleared device (K110812), and thus primarily relies on showing that the modified device remains as safe and effective as the predicate.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance (Accuracy) | "All results were satisfactory and met the predefined specifications." |
| Software Validation | "The CT-Guide modified software was validated and tested." |
| Electromagnetic Compatibility (EMC) | "retested for electromagnetic compatibility per IEC 60601-1-2. testing results observed were as expected." |
| Electrical Safety | "retested for ... electrical safety per IEC 60601-1. testing results observed were as expected." |
| Functionality | "In all instances, the CT-Guide functioned as intended." |
2. Sample Size Used for the Test Set and the Data Provenance
The study was conducted using "several bench tests conducted on a custom phantom setup."
- Sample Size: Not explicitly stated as a numerical sample size of cases or images, but rather described as "several bench tests." The phantom setup implies a controlled, non-human testing environment.
- Data Provenance: The data is from bench tests using a custom phantom, not from human subjects or clinical data (retrospective or prospective). Country of origin is not specified for the phantom tests, but the device manufacturer is based in Israel.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for bench tests on a phantom is typically based on the known physical properties and measurements of the phantom itself, not on expert clinical judgment.
4. Adjudication Method for the Test Set
Not applicable, as ground truth was established through physical measurements on a phantom, not expert review requiring adjudication.
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 MRMC comparative effectiveness study was mentioned. The study described focuses on technical performance of the device itself rather than human reader improvement with AI assistance. This device is a "Needle Guidance System," implying a tool that assists during interventions rather than an AI for diagnostic image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance testing described ("bench tests conducted on a custom phantom setup") would generally be considered a form of standalone performance assessment for the device's accuracy and functionality in a controlled environment, separate from human-in-the-loop clinical use.
7. The Type of Ground Truth Used
The ground truth was established using a "custom phantom setup," implying objective physical measurements and known properties of the phantom.
8. The Sample Size for the Training Set
Not applicable. The description provided is for performance testing of a device's modifications, not for the training of an AI algorithm from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of an AI training set in the document.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.