(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.
§ 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.