(123 days)
The Ultimax-i multipurpose digital X-ray system is designed for gastrointestinal studies, general radiography, and fluoroscopy.
The Ultimax-i system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast enhanced studies, nonvascular contrast-enhanced studies, support of vascular IVR, and general radiography.
Note: This system is not intended for cardiovascular contrast studies or interventional radiology procedures for the cardiac or cerebral blood vessels.
Ultimax-i, DREX-UI80, V1.60 is an image intensified fluoroscopic x-ray system.
The provided text is a clearance letter from the FDA for a medical device (Ultimax-i, DREX-UI80, V1.60). This type of document confirms that the device is substantially equivalent to a legally marketed predicate device and can be sold.
However, a 510(k) clearance letter does not typically contain detailed information about the acceptance criteria, specific device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies in the way you've requested. These details are part of the original 510(k) submission to the FDA, which is a much more extensive document. The clearance letter only summarizes the outcome of the FDA's review.
Therefore, based solely on the provided text, I cannot answer the majority of your questions about the acceptance criteria and the study proving the device meets them. The text primarily focuses on regulatory information, indications for use, and contact details.
Here's what I can extract and what I cannot from the given text:
1. A table of acceptance criteria and the reported device performance:
- Cannot provide. This information is not present in the FDA clearance letter. The letter confirms substantial equivalence, but not the specific performance metrics or acceptance criteria used in the underlying studies.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot provide. This information is not present in the FDA clearance letter.
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):
- Cannot provide. This information is not present in the FDA clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot provide. This information is not present in the FDA clearance letter.
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:
- Cannot provide. The device is an "Image intensified fluoroscopic x-ray system" and a "multipurpose digital X-ray system." There is no mention of "AI" or "human readers" in the context of comparative effectiveness in this document. This suggests it's a traditional imaging system, not an AI-powered diagnostic aide. Therefore, an MRMC study comparing human readers with and without AI assistance is highly unlikely to have been conducted for this type of device as described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot provide. As noted in point 5, there's no indication of an "algorithm" or AI component that would have standalone performance. This appears to be a physical imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot provide. This information is not present in the FDA clearance letter.
8. The sample size for the training set:
- Cannot provide. This information is not present in the FDA clearance letter, and training sets are typically associated with machine learning/AI models, which this device does not appear to be.
9. How the ground truth for the training set was established:
- Cannot provide. This information is not present in the FDA clearance letter.
In summary, the provided document is a regulatory clearance letter, not a scientific study report or the full 510(k) submission. It confirms market authorization based on substantial equivalence to a predicate device, but it does not detail the specific performance studies, methodologies, or data used to establish that equivalence.
§ 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.