(148 days)
The Model S10 is intended for use in displaying and viewing radiography images for review and analysis by trained medical practitioners, and for use in mammography display systems.
The Dome S10 is a widescreen 30-inch 10 megapixel grayscale diagnostic monitor. Its sleek design and high brightness makes the S10 ideal for viewing full field digital mammography and allow it to show two 5MP images for back-to-back chest wall reads.
The provided document is a 510(k) summary for the Dome S10 Color Monitor, a medical display device. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study demonstrating the device's performance against specific acceptance criteria for diagnostic accuracy.
Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding a study proving the device meets acceptance criteria for diagnostic performance.
The document primarily states:
- Intended Use: The Model S10 is intended for use in displaying and viewing radiography images for review and analysis by trained medical practitioners, and for use in mammography display systems. (Page 1, Section L & Page 4)
- Substantial Equivalence: The Dome S10 is substantially equivalent to the predicate device K093197 Coronis Fusion 10MP (MDCG-10130). Both devices have the same indication for use with the same characteristics. Both devices use the same technology and use displays with the same resolution, same number of colors, same refresh rate, same maximum brightness, and the same pixel rise/fall times. (Page 0, Section J)
- Safety Standards: Based upon test results, the model S10 radiology display meets IEC/EN60601-1 and 60601-1-2 standards which establish its safe design and operation. (Page 1, Section N)
In summary, this submission is for a display monitor, and the "acceptance criteria" discussed are related to technical specifications and regulatory compliance for substantial equivalence to an existing monitor, not diagnostic performance of an AI algorithm.
§ 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).