(53 days)
CS Imaging is digital imaging software intended to be used with Carestream Dental's digital imaging devices by healthcare professionals to display, adjust, make measurement, print, export and store digitized images to support image diagnosis in medical care, predominantly in dentistry.
Not Found
Unfortunately, the provided text does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods for proving device performance.
The document is a 510(k) clearance letter from the FDA for a device called "CS Imaging." It primarily addresses the administrative details of the clearance, the device's classification, general regulatory requirements, and its indications for use. It confirms that the device is substantially equivalent to legally marketed predicate devices.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets, data provenance, or the number of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance studies.
- The type of ground truth used or how it was established for either test or training sets.
The "Indications for Use" section (page 3) describes what the software is intended to do (display, adjust, measure, print, export, and store digitized images to support image diagnosis in dentistry), but it doesn't detail any performance metrics or studies to validate these functions beyond the general determination of substantial equivalence.
Therefore, I cannot fulfill the request using only the provided text.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).