(130 days)
The Dornier GENESIS is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.
The Dornier GENESIS is an Image Intensified Fluoroscopic X-ray System (i.e., a solid state x-ray imager (flat panel/digital imager)). The GENESIS consists of the following components: an x-ray generator and tube housing, flat panel detector, monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics and electronics for the imaging chain.
The provided text describes the 510(k) summary for the Dornier GENESIS, an Image Intensified Fluoroscopic X-ray System. The documentation focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets them as would be found for an Artificial Intelligence/Machine Learning (AI/ML) device.
Here's an analysis based on the provided text, addressing the requested points. It's important to note that many of these points are not applicable or cannot be fully answered given the nature of the document (a 510(k) for a conventional medical imaging device, not an AI/ML device).
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific quantitative acceptance criteria or detailed reported device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it states that the GENESIS was tested against recognized testing standards for medical electrical equipment and X-ray systems.
| Acceptance Criteria (Based on standards compliance and stated equivalence) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (General safety) | Device functioned as intended. |
| Compliance with IEC 60601-1-2 (EMC) | Device functioned as intended. |
| Compliance with IEC 60601-1-3 (Radiation protection for diagnostic X-ray) | Device functioned as intended. |
| Compliance with IEC 60601-1-6 (Usability) | Device functioned as intended. |
| Compliance with IEC 60601-2-7 (Safety of high voltage generators) | Device functioned as intended. |
| Compliance with IEC 60601-2-28 (Safety of X-ray source assemblies) | Device functioned as intended. |
| Compliance with IEC 60601-2-54 (Safety and performance of X-ray equipment) | Device functioned as intended. |
| Compliance with FDA Guidance for Solid State X-ray Imaging Devices | All required nonclinical and clinical testing completed; results were as expected. |
| Equivalent performance to predicate Urotract | Concurrence study confirmed the GENESIS has at least equivalent performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "concurrence study" but does not provide details on the sample size used (number of patients or images). It also does not specify the data provenance (country of origin, retrospective or prospective nature).
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 in the document. The nature of the device (a fluoroscopic x-ray system) suggests that evaluation would likely involve assessments of image quality and functionality by subject matter experts, but details are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the test set in the concurrence study.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, particularly one measuring improvement with AI assistance, is not applicable to this device. The Dornier GENESIS is an X-ray imaging system, not an AI/ML diagnostic software. The "concurrence study" mentioned would have focused on comparing the performance of the GENESIS device itself against a predicate device, not on how human readers perform with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable as the Dornier GENESIS is an imaging hardware system, not an algorithm or software that operates in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for the "concurrence study." Given it's an imaging device, ground truth would likely be established through a combination of clinical assessment, potentially comparison to higher-fidelity imaging, or follow-up outcomes, but no specifics are provided.
8. The sample size for the training set
This is not applicable. The Dornier GENESIS is an X-ray imaging system, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
§ 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.