(129 days)
5 Megapixel Monochrome LCD Monitor, RadiForce G51 is intended to be used in various Kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.
RadiForce G51 device is a digital image display. Clearance letter (510(k) No. K032026, dated on AUG 27, 2003) had been issued. The device is qualified for various medical image applications including digital mammography system.
The provided text does NOT include information about acceptance criteria or a study proving the device meets those criteria. The submission is a 510(k) premarket notification for a medical display monitor (RadiForce G51).
The core of a 510(k) submission is to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove the device meets specific performance acceptance criteria through a clinical study. The provided documents focus on:
- Device Identification: Naming the device, manufacturer, and official correspondent.
- Classification: Identifying the regulatory classification and product code.
- Predicate Device Comparison: Listing the predicate device and comparing the new device's technical specifications to it. This is the primary method used to demonstrate substantial equivalence for this type of device.
- Intended Use: Stating how the device is meant to be used.
- FDA Clearance Letter: Confirming that the FDA has reviewed the submission and found the device substantially equivalent.
Therefore, I cannot populate the table or answer the questions related to acceptance criteria and a study proving device performance because this information is not present in the provided text.
The document details the device's technical specifications and compares them to a predicate device, but it does not describe any specific performance acceptance criteria or a study designed to evaluate how the device performs against those criteria using a test set, expert readers, or ground truth.
§ 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).