(85 days)
The Lasershare Print Spooler and/or Software is a distributable filming management system that receives digital images and format control data from various image sources (including, but not limited to, CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, removable storage media or other imaging sources) connected point to point or via networks. The incoming data formats are standard medical imaging formats or proprietary to the modality source vendor. The Lasershare Print Spooler and/or Software allows the operator to manage print job requests, create filming sessions and route image and patient data to one or more laser film printers, thermal dye sublimation and dry printers and other medical imaging print devices.
The Lasershare Print Spooler is designed to accept images from various modalities or digital image networks and direct images to one or more medical imaging print devices, providing spooling and queue management facilities. Core technology for the Lasershare Print Spooler is based on, and various software components ported from, the Imageshare 910 Protocol Converter (a predicate device). The Lasershare is a modular system that uses network interfaces for communication between the modules. Network interfaces enable the various modules to reside on local or remote machines. The Lasershare Print Spooler and/or Software is designed to run on off-the-shelf, general purpose computing equipment. The application software is designed for maximum portability across operating systems and hardware platforms. Performance of the application software is primarily a function of network load; secondarily a function of the hardware platform's computational speed and finally the performance of the printer(s). Intrinsic performance of the application does not change significantly as it is ported from one operating system to another.
This document is a 510(k) summary for the Lasershare Print Spooler and/or Software. It is a premarket notification for a medical device that aims to demonstrate its substantial equivalence to other legally marketed devices.
Based on the provided text, the device is not an AI/ML diagnostic tool but rather a digital imaging network spooler. Its function is to manage and route digital medical images to various printing devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable to this type of device. The provided text focuses on device description, intended use, and substantial equivalence to predicate devices, which is standard for a 510(k) submission for this class of device.
There is no performance data or clinical study presented as would be required for a diagnostic or AI-powered device with performance metrics like sensitivity, specificity, etc. The "performance characteristics" mentioned in section 4.2 refer to technical aspects like network load and computational speed, not diagnostic accuracy.
§ 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.