(85 days)
Artis zee / zeego 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 zee / zeego family include cardiac angiography, general angiography. rotational angiography, multipurpose angiography and whole body radiographic fluorossopic 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 zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.
The Artis zee and Artis zeego include also the software option DynaCT which identifies the Artis as a system with a Carm CBCT functionality.
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 soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.
Artis zee / zeego Modular Anqiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. This submission contains Quantitative CARE claims to be added.
The Artis zee / zeego Modular Angiography System with the Quantitative CARE claims is the same Angiography System cleared in 510(k) K122644 with the addition of CARE Claims cleared in 510(k) K123529 the Artis Q and Artis Q.zen Modular Angiography systems. All components are described in the Device Description Section 10 and the Substantial Equivalence Section 11.
The provided text does not contain detailed information about specific acceptance criteria and a study proving a new device meets these criteria in the typical sense of a clinical or performance study with defined statistically significant endpoints.
Instead, this document is a 510(k) summary for a Siemens Artis zee/zeego angiography system (software version VC21), where the manufacturer is claiming substantial equivalence to previously cleared predicate devices. The core of the submission is to justify that the "Quantitative CARE claims" for this system are substantially equivalent to those cleared in a different system (Artis Q and Artis Q.zen).
Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert adjudication, or MRMC studies for a new device's performance because this information is not present in the provided text. The document focuses on regulatory compliance and equivalence to existing devices, not a de novo performance study.
However, I can extract the relevant information regarding the type of evaluations performed and the basis for the substantial equivalence claim:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the format of a clinical performance table with specific acceptance criteria and corresponding reported statistical performance metrics. Instead, the document states:
"The Artis zee / zeego Modular Angiography System with the Quantitative CARE claims is the same Angiography System cleared in 510(k) K122644 with the addition of CARE Claims cleared in 510(k) K123529 the Artis Q and Artis Q.zen Modular Angiography systems."
And, regarding non-clinical testing:
"The testing results supports that all software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence."
This implies that the acceptance criteria are met by demonstrating the updated system functions as expected and consistent with the predicate devices, and that the "Quantitative CARE Claims" perform similarly to how they performed on the Artis Q and Q.zen systems. Specific numerical performance metrics for these claims are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document focuses on showing that the new device (Artis zee/zeego with VC21 and CARE claims) is substantially equivalent to legally marketed predicate devices, not on a new clinical study. The non-clinical testing mentioned refers to "integration and functional" software tests, not typically requiring a clinical test set with patient data or provenance.
3. 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)
This information is not provided. The document does not describe a clinical study where experts established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No expert adjudication method is described.
5. 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 comparative effectiveness study is mentioned. The device is not described as an AI-assisted device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a performance study for a standalone algorithm. The device is a complete angiography system. The "Quantitative CARE claims" imply automated measurements or optimizations, and the non-clinical testing confirmed "all software specifications have met the acceptance criteria," but specific standalone performance metrics are not given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated. Given that the submission is for substantial equivalence and involves "Quantitative CARE Claims," the ground truth for validating these claims would likely have been established during the development and clearance of the predicate Artis Q and Q.zen systems. This would typically involve comparison to established methods or gold standards for quantitative measurements in angiography. However, details are not in this summary.
8. The sample size for the training set
This information is not provided. The document describes software modifications and the addition of previously cleared "CARE Claims" to an existing system, not the development of a de novo algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not provided, as the concept of a "training set" in the context of this 510(k) submission is not applicable.
§ 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.