(383 days)
The Dornier GENESIS II 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 II is an Image Intensified Fluoroscopic X-ray System. It 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 Genesis II consists of the following components: an x-ray generator and tube housing, image intensifier 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 Genesis II is a radiographic and fluoroscopy examination table with the X-ray tube housing mounted over the table on a fixed arm. An image intensifier is mounted underneath the patient table. While the X-ray tube and detector are fixed in their positions relative to each other when the system is in use, the table top and X-ray/detector unit can be moved in a variety of planes to position the patient in the desired imaging position.
The provided text describes the 510(k) premarket notification for the Dornier MedTech America, Inc. Genesis II device, an Image Intensified Fluoroscopic X-ray System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific quantitative acceptance criteria.
However, based on the information provided, we can infer some aspects and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Acceptable diagnostic image quality for intended uses. | A board-certified radiologist evaluated a number of sample images obtained using the Genesis II and determined that the device output images were of acceptable diagnostic quality. |
| Compliance with relevant medical electrical safety standards. | The device is in compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54, and NEMA PS 3.1-3.20 (DICOM Set). |
| Not raising new questions of safety or effectiveness compared to predicate devices. | The use of a cleared image intensifier technology (identical to that in Dornier Gemini Lithotripter system K121656) in the Genesis II, which has similar indications for use to other FDA-cleared uroradiology systems (e.g., Urotract I K955019), does not raise any new questions of safety or effectiveness. The device has the same intended use and indications for use as the predicate Genesis system (K122768). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document states, "a board certified radiologist evaluated a number of sample images obtained using the Genesis II." A specific numerical sample size is not provided.
- Data Provenance: The origin of the sample images (e.g., country of origin) and whether the data was retrospective or prospective is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "a board certified radiologist" — this suggests one expert.
- Qualifications of Experts: The expert was a "board certified radiologist." No further detail (e.g., years of experience) is provided.
4. Adjudication method for the test set
- "a board certified radiologist evaluated... and determined..." This indicates that the evaluation was performed by a single expert. There is no mention of an adjudication method involving multiple experts to establish ground truth or resolve discrepancies, as only one expert is noted.
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, an MRMC comparative effectiveness study was not done. The document describes the evaluation of image quality of the device itself, not the performance of human readers with or without AI assistance. This device is an imaging system, not an AI-based diagnostic tool for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the Genesis II is an X-ray imaging system, not an algorithm or AI device that performs diagnoses independently. The evaluation described is for the diagnostic quality of the images produced by the hardware, which would then be interpreted by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the image quality assessment was established through expert opinion/evaluation by a single board-certified radiologist, who determined if the images were of "acceptable diagnostic quality." There is no mention of an objective reference standard like pathology or outcomes data.
8. The sample size for the training set
- The document implies that the device (Genesis II) itself was designed and verified against established engineering and safety standards, and its image intensifier technology is based on previously cleared devices. It does not describe a "training set" in the context of an algorithm or AI model. Therefore, this question is not applicable for this type of device submission.
9. How the ground truth for the training set was established
- As the concept of a "training set" for an algorithm is not applicable to this device, the establishment of its ground truth is not relevant in this context. The device's "training" in a functional sense would be its design, manufacturing processes, and adherence to established technical standards, as well as the prior clearance of its component technologies.
§ 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.