(82 days)
XperGuide is an extension of XperCT, which assists in percutaneous interventions, such as biopsies, drainages, etc.. by providing needle path planning and image guidance by superimposing live fluoroscopic images of the needle on a cross sectional image of the targeted anatomy.
The XperGuide Ablation option assists with planning the position of multiple needles by visualizing the ablation coverage of the lesion.
XperGuide is a software medical device intended to assist the physician during percutaneous interventions by providing live 3D needle image guidance. XperGuide overlays live 2D fluoroscopic images on a 3D reconstruction of the anatomy. XperGuide provides real-time feedback on needle position with respect to the planned path. In addition, the XperGuide has an ablation option, which visualizes the combined ablation zone of multiple planned needles.
Here's an analysis of the provided text regarding the XperGuide device, focusing on acceptance criteria and supporting studies:
This document ([K131263](https://510k.innolitics.com/search/K131263)) is a 510(k) Summary of Safety and Effectiveness, not a detailed study report. Therefore, it provides a high-level overview and states that tests were performed, but does not provide specific numerical acceptance criteria or detailed study results. It mainly focuses on substantiating equivalence to a predicate device.
Acceptance Criteria and Reported Device Performance
The document states generally that "The test results demonstrate that XperGuide meets the acceptance criteria, and is adequate for its intended use." However, no specific quantitative acceptance criteria or corresponding device performance values are reported in the provided text.
The acceptance criteria are implicitly related to the device successfully performing its intended functions (live 3D needle image guidance, overlay of live 2D fluoroscopic images on 3D anatomy, real-time feedback on needle position, ablation option visualization) and complying with relevant standards and risk management results.
The key acceptance criteria, while not quantified in a table, can be inferred as:
- Compliance with IEC 62304 (Medical device software Software life cycle processes)
- Compliance with IEC 62366 (Application of usability engineering to medical devices)
- Compliance with ISO 14971 (Application of risk management to medical devices)
- Successful software verification and validation conformance testing.
- Demonstration of substantial equivalence to predicate devices (Innova Vision Applications with TrackVision option).
The "reported device performance" is summarized as having met these implied criteria.
Study Information
The document describes "Non-clinical verification and validation tests" that were performed. This is a general statement about the type of study conducted rather than a specific clinical trial.
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A table of acceptance criteria and the reported device performance:
As explained above, this information is not provided in the requested tabular format with specific numerical criteria. The document broadly states that tests demonstrated the device meets acceptance criteria and is adequate for its intended use and is substantially equivalent to a predicate device. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not specified. The document mentions "non-clinical verification and validation tests" but does not detail any specific test sets, their sizes, or data provenance. Given the focus on substantial equivalence to a software product, these tests likely involved software testing environments rather than patient data in the sense of a clinical study. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not specified. This type of detail is typical for clinical performance studies, which this document does not describe. The "ground truth" for software verification would involve adherence to functional specifications and usability standards, likely evaluated by software engineers / quality assurance personnel and usability experts. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified. As there is no mention of a formal clinical test set requiring expert adjudication, this information is not relevant to the described non-clinical tests. -
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 study was done or reported. This device is an image guidance system, not an AI diagnostic tool for interpreting images. Its purpose is to assist interventional procedures by overlaying images and providing real-time feedback, rather than to improve reader diagnostic accuracy. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The document describes "software verification and validation conformance testing." This type of testing would assess the algorithm's standalone functionality against its design specifications. However, the device itself is explicitly intended to be human-in-the-loop ("intended to assist the physician during percutaneous interventions"). Therefore, while individual software modules would undergo standalone testing, the performance of the device as a whole is inherently linked to human interaction. The document does not isolate "algorithm only" performance explicitly separate from the system's intended interactive use. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For "non-clinical verification and validation tests," the ground truth would primarily be the functional specifications, design documents, and relevant international standards (IEC 62304, IEC 62366, ISO 14971). For aspects related to image overlay accuracy, the "ground truth" would be established by comparing the device's output to known anatomical models or precisely calibrated phantom setups. -
The sample size for the training set:
Not applicable / Not specified. This document describes a software medical device, XperGuide, an image guidance system. It is not presented as a machine learning or deep learning device that requires a "training set" in the conventional AI sense. The software's functionality is based on algorithms that perform image fusion, overlay, and tracking, not on learning from a large dataset to make predictions. -
How the ground truth for the training set was established:
Not applicable, as there is no "training set" described for this device in the context of machine learning.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.