(107 days)
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Procedures that can be performed with the ARTIS family include cardiac angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Additional procedures that can be performed include angiography in the operating room, image-guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions.
ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.
The ARTIS family include also the software option DynaCT with following indications for use:
DynaCT is an X-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.
The ARTIS pheno is a further development of the Artis Q and Artis Q.zen -Modular Angiography System. ARTIS pheno is equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table, and image post processing. syngo Application Software is optional available for the support of dedicated clinical workflows.
The provided text describes the ARTIS pheno device and its substantial equivalence to predicate devices, but it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.
The document states that "Non-clinical tests were conducted for ARTIS pheno, during product development" and that "The modifications described in this Premarket Notification were supported with verification and validation testing." It also mentions "The performance data demonstrates continued conformance with special controls for medical devices containing software" and "The testing results support that all the software specifications have met the acceptance criteria."
However, it does not provide the actual acceptance criteria or the specific numerical performance results achieved by the device in a table format. It only lists various standards the device complies with (e.g., ES60601-1:2005/(R)2012) and general statements about the tests being passed.
Therefore, I cannot populate the requested table or provide detailed answers to questions 2 through 9 based on the provided text. The document refers to "non-clinical performance testing" and "verification and validation testing" but does not elaborate on the specific methodologies, sample sizes, ground truth establishment, or expert involvement for these tests.
Summary of available information regarding performance:
- Acceptance Criteria/Reported Performance: Not explicitly stated in a quantifiable manner or table. The document generally states that "all tests were passed" and that "all the software specifications have met the acceptance criteria."
- Sample size for test set and data provenance: No information provided.
- Number of experts and qualifications for ground truth: No information provided.
- Adjudication method: No information provided.
- MRMC comparative effectiveness study: No information provided.
- Standalone (algorithm only) performance: No information provided the software is a component of the interventional fluoroscopic x-ray system, not a standalone AI device with specific algorithmic performance metrics.
- Type of ground truth used: "Non-clinical performance testing" and "software specifications" are mentioned, suggesting internal validation against defined functional requirements and safety standards. No mention of expert consensus, pathology, or outcomes data for performance evaluation in the context of diagnostic accuracy.
- Sample size for training set: No information provided.
- How ground truth for training set was established: No information provided.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, adherence to safety and performance standards for an interventional fluoroscopic x-ray system, and successful completion of verification and validation activities. It does not provide the kind of detailed study results one might expect for a novel AI/CAD device.
§ 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.