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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, is a fixed C-arm fluoroscopic device intended to provide radiographic and fluoroscopic images in a variety of studies. The unit consists of a C-arm with X-ray tube, beam limiter and digital flat panel detector (FPD), a wireless flat panel detector, a patient table that can tilt in both directions, an 80kW X-ray generator, an overhead tube support assembly, an image processor and both remote and table side control.

This document (K181834) describes a 510(k) premarket notification for the Ultimax-i, DREX-UI80, V1.60, an image-intensified fluoroscopic x-ray system. The submission concerns a modification to a previously cleared device (K170832) by adding a wireless general radiography solid-state x-ray detector (TFP-1417W).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance criteria or quantitative performance metrics for the device itself. Instead, it focuses on demonstrating substantial equivalence to a predicate device after a modification. The acceptance criteria appear to be implicit in the regulatory standards and the demonstration that the modification does not negatively impact the system's performance or intended use.

The relevant statement is:
"This submission contains integration test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system."

Given the information, an inferred "acceptance criteria" and "reported performance" table would look like this, though it's the lack of specific numbers that is notable:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the sample size used for the integration test data. It broadly states "integration test data."
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only mentions that the manufacturing site is Canon Medical Systems Corporation in Tochigi-ken, Japan.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The study described is not a clinical study involving experts establishing ground truth for diagnostic accuracy, but rather an engineering and integration test to demonstrate equivalence after a hardware modification.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. There is no mention of a human-read test set requiring adjudication in this technical submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and Effect Size:

No, an MRMC comparative effectiveness study was not done as described in this submission. This is a technical modification submission, not a human reader performance study. The focus is on the device's technical performance and safety, not on how human readers interact with or improve using the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable in the context of an x-ray imaging system being developed. The "device" itself is the imaging system (hardware and associated software), not an AI algorithm that produces an output for interpretation. The software version (V1.6) remained unchanged from the predicate device and thus no new software performance testing was required beyond integration.

7. The Type of Ground Truth Used:

The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., pathology, outcomes data) is not explicitly stated or relevant to the type of testing described. The "truth" here is the technical performance of the system against established engineering and safety standards, as well as its functional equivalence to the predicate. This would have been established through phantom measurements, quality assurance checks, and functional testing to ensure image quality, dose, and system operation were maintained or improved.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The device is an x-ray imaging system, not an AI algorithm that requires a training set for model development. The software was already developed and its version (1.6) was not changed as part of this submission.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/not provided for the same reasons as point 8.

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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.

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