(73 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 and liver, 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.
Here's an analysis of the provided text regarding the CT-Guide Needle Guidance System's acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the device's performance (e.g., target accuracy in millimeters, success rate percentage). Instead, it uses qualitative statements about the studies' outcomes.
Since specific acceptance criteria are not provided, the table below will reflect the general statements made in the document about performance.
| Acceptance Criteria (Not explicitly quantified in source) | Reported Device Performance |
|---|---|
| Device functions as intended. | "The CT-Guide functioned as intended" |
| Satisfactory performance. | "All results were satisfactory" |
| Met predefined specifications. | "met the predefined specifications" |
| Safe and effective for intended use. | "The results demonstrate that the system is safe and effective for its intended use." |
| Testing results were as expected. | "the testing results observed were as expected." |
| Biocompatibility requirements met (ISO 10993-1). | "Skin contacting materials were tested for biocompatibility per ISO 10993-1." |
| Electromagnetic compatibility met (IEC 60601-1-2). | "The CT-Guide System was tested for electromagnetic compatibility... per IEC 60601-1 and IEC 60601-1-2." |
| Electrical safety met (IEC 60601-1). | "The CT-Guide System was tested for... electrical safety per IEC 60601-1 and IEC 60601-1-2." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only states "a prospective, multi-center clinical study was conducted."
- Data Provenance: Prospective, multi-center clinical study. The country of origin is not explicitly stated for the clinical study data itself, although the submitter is based in Israel and the FDA clearance is for the US market. The bench tests were done on a "custom phantom setup," implying laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The document only mentions a "prospective, multi-center clinical study" but does not detail how outcomes were assessed or adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The study described is an evaluation of the device's performance in clinical use, not a comparison of human readers with and without AI assistance.
- Effect Size: Not applicable, as an MRMC study was not described.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: The core function of the CT-Guide is a guidance system that displays instruments on a CT-based model for a human operator. The "Performance Data" section discusses "bench tests conducted on a custom phantom setup" and "The CT-Guide software was validated and tested." These could be interpreted as standalone tests of the system's accuracy and software functionality prior to human interaction within the clinical study. However, the document doesn't explicitly separate "algorithm only" performance from the overall system's performance, as the system's purpose is to guide human intervention. The clinical study implicitly includes human interaction.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the clinical study, the ground truth or outcome measure is implied to be related to the successful and safe conduct of "clinical interventions in the lung and liver." The document states, "The results demonstrate that the system is safe and effective for its intended use." This suggests clinical outcomes and safety profiles served as the ground truth. For the bench tests, the ground truth would have been derived from the "custom phantom setup" with known geometrical properties or reference points.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The document describes a medical device (hardware and software) that assists in procedures, not a machine learning or AI model that requires a "training set" in the conventional sense. The "CT-Guide software was validated and tested," which likely refers to traditional software verification and validation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as no machine learning training set is described.
§ 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.