(72 days)
The Olicon Gateway is a uni-directional device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, imaging gateways, or other imaging sources).
The incoming data formats are ACR-NEMA v2.0, DICOM, or SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Olicon Gateway, converts the imaging or other data into DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary data format and transmits the data to one or more user specified locations across a standard general purpose computing network.
Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.
The Olicon Gateway system is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which runs a protocol conversion software application that uses defined configuration to receive, reformat, and transmit images and demographic information. The system is capable of receiving images from different sources and routes them automatically to predefined destinations.
The provided text describes the Olicon Gateway, a device for converting and transmitting digital images and data, and its 510(k) submission. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
The document primarily focuses on:
- Device Description: What the Olicon Gateway is and how it functions as a protocol converter.
- Indications for Use: The purpose and scope of the device.
- Technological Characteristics: Reinforcing its function as a general-purpose computer system with software for protocol conversion.
- Safety and Effectiveness (Performance Data): It only mentions that "The subject and predicate devices both use standard data communications controls to detect and correct errors" and that "The subject device complies with UL-1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment."
- Conclusion on Substantial Equivalence: It asserts equivalence to a predicate device (DEJARNETTE RESEARCH SYSTEMS IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE - K963592) based on shared safety features (UL-1950 compliance, reliance on human intervention for interpretation, password protection) and functional similarity as a communications protocol converter.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as these details are not present in the provided text. The document is a 510(k) summary, which often focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with quantitative metrics.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.