(29 days)
The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.
The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide SuperPROBE platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting.
The Clear Guide SCENERGY guidance system is intended to be an accessory to existing ultrasound imaging systems, to provide image fusion, instrument tracking, and image/instrument guidance functionality to operators during image-guided medical interventions that utilize data from multiple modalities (e.g., ultrasound and computed-tomography (CT), ultrasound and magnetic resonance (MR)). The Clear Guide SCENERGY uses optical detection technology to identify and track objects in the field of view. By pairing this information with the aforementioned imaging data, the Clear Guide SCENERGY executes proprietary software algorithms to display fused images in real-time to the clinician. These segmentation and registration algorithms are automated. Segmentation results are deterministic, meaning that new inputs (e.g., new CT or MR) would be required to change the segmentation output. Registration can be reset by the user at any time during use.
Here's a breakdown of the acceptance criteria and study information for the Clear Guide SCENERGY device based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the types of testing performed but does not explicitly state quantitative acceptance criteria or reported device performance metrics in a clear, tabular format. It states that "Performance testing of the Clear Guide SCENERGY device demonstrates that the product accurately achieves its intended use, while also showing that differences in technological features from the predicate device did not affect device performance." And, "Results of performance testing show that the subject device is as safe and as effective as the predicate device."
However, it describes the metrics used for evaluation:
| Test Type | Metric | Reported Device Performance |
|---|---|---|
| Segmentation Testing | Comparison of software outputs to manual selection of fiducial markers. | Demonstrated satisfactory performance (implied by conclusion of substantial equivalence) |
| Fusion Testing | Tissue Registration Error (TRE): Distance measurements between identifiable landmarks or surfaces seen on ultrasound and CT, or ultrasound and MR. | Demonstrated satisfactory performance (implied by conclusion of substantial equivalence) |
| Systematic Error (Tip-to-Tip) Testing | "Tip-to-Tip" distance: From the needle point seen by ground truth CT (or MR) to the same needle point seen by Clear Guide SCENERGY's displayed guidance. (Also referred to as "tracking error" in literature for the predicate device.) | Demonstrated satisfactory performance (implied by conclusion of substantial equivalence) |
Important Note: The document does not provide specific numerical values for TRE, "tip-to-tip" distance, or segmentation accuracy. It relies on a qualitative statement of meeting its intended function and being "as safe and as effective as the predicate device."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document states that "Phantom datasets were utilized for this evaluation" for Systematic Error Testing, and "phantom datasets" were also used for Segmentation Testing. However, no specific number or size of these phantom datasets is provided.
- Data Provenance: "Phantom datasets" were used. This indicates simulated or artificial data, not human patient data. The document does not specify the country of origin for these phantom datasets, nor whether they are retrospective or prospective. Given they are phantoms, the latter distinction is less relevant.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document mentions "manual selection" for segmentation testing and "ground truth CT (or MR)" for systematic error testing. It implies that these "ground truths" are objective measures or expert-derived, but it does not specify the number of experts, their qualifications, or how they established the ground truth.
4. Adjudication Method:
- The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document primarily focuses on technical performance testing against a predicate device's established safety and effectiveness. It does not mention human reader performance or improvements with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, standalone performance testing was done. The described "Segmentation Testing," "Fusion Testing," and "Systematic Error (Tip-to-Tip) Testing" evaluate the device's algorithmic performance (e.g., software outputs compared to manual selection, distance measurements for fusion and guidance accuracy) directly without human-in-the-loop interaction for the reported metrics. The device's segmentation and registration algorithms are described as "automated."
7. Type of Ground Truth Used:
- For Segmentation Testing: "Manual selection in phantom datasets." This implies an expert-derived ground truth.
- For Fusion Testing: "Identifiable landmarks or surfaces seen on ultrasound and CT, or ultrasound and MR." This suggests comparison against established anatomical structures or markers within the imaging modalities.
- For Systematic Error (Tip-to-Tip) Testing: "Ground truth CT (or MR)." This indicates reference imaging data as the standard.
Overall, the ground truth appears to be a combination of expert-derived measurements/selections and reference imaging data (CT/MR).
8. Sample Size for the Training Set:
- The document does not provide any information regarding the sample size used for the training set. It focuses on the validation of the device.
9. How the Ground Truth for the Training Set Was Established:
- The document does not provide any information regarding how the ground truth for the training set was established, as it does not discuss the training phase of the algorithms.
§ 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.