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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. The Lasershare Print Spooler and/or Software is a different model of the current Lasershare Print Spooler and/or Software [predicate device], ported to another operating system. 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.

This submission [K973422](https://510k.innolitics.com/search/K973422) is for a "Lasershare Print Spooler and/or Software", which is classified as an "accessory" to a "System, Digital Image Communication". This device is a print spooler that manages and routes digital medical images to various printing devices.

Based on the provided document, the device's main function is to handle and route images for printing. This type of device is very different from diagnostic AI/ML software, and therefore, an acceptance criteria table related to diagnostic performance, sample sizes for test sets, expert involvement, and ground truth establishment, which are typical for AI/ML device studies, are not applicable to this submission.

This is primarily a software utility focused on interoperability and management of imaging data for printing purposes, not diagnostic accuracy or interpretation. The performance characteristics described are related to software portability, network load, and hardware compatibility rather than clinical efficacy in diagnosis.

The submission focuses heavily on substantial equivalence to an existing predicate device, highlighting that any differences between the new device and the predicate have no significant influence on safety or efficacy related to its core function as a print spooler.

Therefore, many of the requested items (1, 2, 3, 4, 5, 6, 7, 8, 9) related to clinical performance studies, such as diagnostic accuracy, expert review, and ground truth, are not present in this 510(k) summary because they are not relevant to the function or regulatory classification of a print spooler as a device accessory.

The device's "performance" in this context refers to its ability to manage print jobs, route images, and operate across different systems, as described in section 4.2: "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."

The study proving the device meets acceptance criteria, in this case, would have been a demonstration of this software's ability to perform its defined printing and routing functions, likely through internal validation and comparisons to the predicate device in terms of functionality and system compatibility, rather than a clinical trial.

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