(351 days)
The AXIOM Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.
The AXIOM Iconos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA).
AXIOM Luminos dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
AXIOM Luminos dRF is a universal fluoroscopic x-ray diagnostic system (R/F system), with an overtable X-ray tube assembly. This system is a modified and upgraded version of the URF Digital OT, which now is equipped with a Flat detector instead of an image intensifier.
AXIOM Luminos dRF can be configured as a single tube system, with only an overtable tube or it can be combined with an additional 3D overhead tube crane, that can be moved longitudinally and laterally as well as vertically and a bucky wall stand.
For processing the digital images from the Digital Imaging System the AXIOM Luminos dRF is equipped with the Fluorospot COMPACT digital imaging system.
The provided document is a 510(k) summary for the AXIOM Luminos dRF, an X-ray system. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics like sensitivity or specificity.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: The document does not define specific performance-based acceptance criteria (e.g., in terms of image quality metrics, diagnostic accuracy) that the device was tested against.
- Sample size used for the test set and data provenance: No performance study involving a test set is described. The comparison is based on technological characteristics and intended use.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment for a test set is mentioned.
- Adjudication method for the test set: Not applicable as no test set evaluation is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: No MRMC study is mentioned. The comparison is between devices, not human readers with and without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a diagnostic imaging system, not an AI algorithm, so this concept doesn't directly apply in the way it would for AI-based software.
- The type of ground truth used: Not applicable as no performance study is detailed.
- The sample size for the training set: Not applicable as it's a hardware device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The document primarily demonstrates substantial equivalence to existing predicate devices (URF Digital OT / AXIOM Iconos and components from AXIOM Aristos FX Plus and AXIOM Artis modular Angiography system) by highlighting similarities in intended use and technological characteristics. The logic is that if the new device is technologically similar and used for the same purpose as a legally marketed device, it is considered safe and effective.
The provided text describes the device as a "universal fluoroscopic x-ray diagnostic system (R/F system)" and mentions that "Many of the components used in AXIOM Luminos dRF are either commercially available with current Siemens systems or include minor modifications to existing components." It also states, "The Flat Detector Pixium 5100 equipped with AXIOM Luminos dRF is an improved detector and substantial equivalent to the Pixium 4600 used with AXIOM Aristos FX Plus and substantial equivalent to the Pixium 4800 used with AXIOM Artis modular Angiography system."
Regarding "General Safety and Effectiveness Concerns," the document states:
- "Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner."
- "Several safety features including visual and audible warnings are incorporated into the system design."
- "The AXIOM Luminos dRF is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed."
- "Furthermore the operators are health care professionals familiar with, and responsible for, the X-ray examinations to be performed."
- "To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing."
These points indicate adherence to general safety standards and operational practices rather than specific quantitative performance acceptance criteria. The "final performance testing" mentioned is general and not detailed in terms of specific metrics or a clinical study.
§ 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.