(28 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 Optical Head 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, 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, in patients of sufficient size (at least 25 kg).
The CLEAR GUIDE SCENERGY is a medical guidance and navigation software system that provides image fusion, instrument tracking, marker tracking, and target planning functionalities to operators during imageguided diagnostic or interventional procedures. The system uses data from multiple compatible imaging modalities that includes computed-tomography (CT), magnetic resonance imaging (MRI), or diagnostic ultrasound (US).
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 ning that new inputs (e.g., a new CT or MRI) would be required to change the segmentation output. Registration can be reset by the user at any time during use.
The provided text describes the Clear Guide SCENERGY device and its K234030 510(k) submission, confirming its substantial equivalence to a predicate device. However, the document does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics (e.g., sensitivity, specificity, accuracy) for the Clear Guide SCENERGY device itself beyond a general statement about clinical validation and intended use.
The clinical study mentioned (NCT05573048, "A Study of Optical Fusion Trans-Perineal Grid") focused on validating the workflow and characterizing the intervention accuracy of the device's modifications, specifically the new "PLAN" user interface and support for the SteriGRID accessory. It confirmed that the device "accurately achieved its intended use" without adverse effects or new risks, and that its performance was within the existing device performance. However, specific numerical acceptance criteria (e.g., target accuracy in millimeters) and the device's reported performance against those criteria are not detailed in the provided text.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific numerical acceptance criteria for performance metrics (such as accuracy, sensitivity, specificity, etc.) for the Clear Guide SCENERGY device, nor does it present reported device performance against such metrics. It generally states that the device "accurately achieved its intended use" and that its performance was "within the existing device performance."
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: 10 patients
- Data Provenance: Clinical data from a "small clinical testing" study (NCT05573048, "A Study of Optical Fusion Trans-Perineal Grid"). The country of origin is not explicitly stated, but clinicaltrials.gov is a US-based registry, suggesting it was likely conducted in the US or a region adhering to similar clinical trial standards. The study was prospective in nature, as it was a "clinical validation study" run to "further test the safety and effectiveness of the modifications."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the given text. While it mentions the study was run to test safety and effectiveness, it does not detail how ground truth for accuracy was established, nor the involvement or qualifications of experts for this purpose.
4. Adjudication Method for the Test Set:
This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned as being done for the K234030 submission. The clinical testing focused on validating the workflow and intervention accuracy of the modifications to the device itself, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document states that the "segmentation and registration algorithms are automated." The clinical testing focused on the overall device performance in a clinical workflow, which would inherently include human interaction with the system. While the algorithms themselves are automated, the described clinical study is not presented as a standalone, algorithm-only performance evaluation, but rather a validation of the modified device (which incorporates the algorithms) in a clinical context. The text does not provide specific metrics solely for the algorithmic performance in isolation.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The document mentions that the study "characterized the intervention accuracy within the existing device performance." It also refers to experiments using a "perineal template to facilitate needle localization for focal laser ablation of cadaveric prostate" as a comparison, which implies a physical measurement of accuracy. However, the specific method for establishing ground truth (e.g., direct measurement, post-procedure imaging, pathology confirmation) for the 10-patient clinical study is not detailed.
8. Sample Size for the Training Set:
This information is not provided in the given text. The document states that the "segmentation and registration algorithms are automated" and "proprietary," but it does not disclose details about their training.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the given text.
§ 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.