(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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2017
Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K170832
Trade/Device Name: Ultimax-i, DREX-UI80, V1.60 Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: June 13, 2017 Received: June 16, 2017
Dear Mr. Biggins:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170832
Device Name
Ultimax-i, DREX-UI80, V1.60
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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.