(264 days)
The UDI 2 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on connomar monitor, without the time and costs involved with the film or cassette handling. The image can has further manipulated on a the computer monitor via imaging software, can be printed and/or e-mailed. The DI 2 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" x 14" x 17" sensor plate captures large patient imaging and areas.
Universal Digital Interface 2 (UDI 2)
This document is a 510(k) clearance letter for the Universal Digital Interface 2 (UDI 2) and does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The letter primarily states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, many of the requested details are not present in the provided text.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document. The FDA letter is a regulatory clearance based on substantial equivalence, not a performance report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the document. The letter does not detail the testing methodology or data sets used for demonstrating substantial equivalence.
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 present in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the document.
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:
This information is not present in the document. The UDI 2 is described as a "Direct Digital Radiography Upgrade unit" that converts X-ray images to digital; there is no indication that it includes AI or that an MRMC study related to AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present in the document. The device description does not suggest an "algorithm-only" performance evaluation as it is an imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not present in the document.
8. The sample size for the training set:
This information is not present in the document.
9. How the ground truth for the training set was established:
This information is not present in the document.
Summary of what the document does provide:
- Device Name: Universal Digital Interface 2 (UDI 2)
- 510(k) Number: K140251
- Primary Function: A Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images.
- Output: Diagnostic images viewable on a monitor, which can be manipulated, printed, and/or e-mailed.
- Application: Provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics, and imaging centers.
- Sensor Plate Size: 17" x 17" or 14" x 17".
- Regulatory Status: Substantially equivalent to legally marketed predicate devices, Regulatory Class II.
- Type of Use: Prescription Use.
To obtain the detailed information regarding acceptance criteria and study results, one would typically need to refer to the full 510(k) submission documentation, which is not included in this FDA clearance letter.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2014
Meridian Medical Systems, LLC % Mr. Larry Cornell Managing Director 325 Harris Drive AURORA OH 44202
Re: K140251
Trade/Device Name: Universal Digital Interface 2 (UDI 2) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 19, 2014 Received: September 22, 2014
Dear Mr. Cornell:
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.
Sm.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140251
Device Name Universal Digital Interface 2 (UDI 2)
Indications for Use (Describe)
The UDI 2 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on connomar monitor, without the time and costs involved with the film or cassette handling. The image can has further manipulated on a the computer monitor via imaging software, can be printed and/or e-mailed. The DI 2 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" x 14" x 17" sensor plate captures large patient imaging and areas.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.