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The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components may provide functions for performing related to image manipulation, enhancement, compression or quantification. And images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic operations.

The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components may provide functions for performing related to image manipulation, enhancement, compression or quantification.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, or adjudication methods for a medical device study.

The document is an FDA 510(k) clearance letter for a device named "QXLink". It states that the device is substantially equivalent to a legally marketed predicate device. The letter primarily addresses regulatory compliance and provides indications for use for the QXLink device, which is a Picture Archiving and Communications System (PACS).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria based on the given information.

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The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage and digital processing of medical images. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic operations.

Picture archiving and communication system (PACS)/ QXLink

This is a 510(k) clearance letter for the QXLink PACS device. As such, it primarily focuses on establishing "substantial equivalence" to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for the QXLink device itself.

Therefore, the requested information about acceptance criteria and a study proving the device meets them is not available in the provided document. This document confirms the regulatory clearance based on substantial equivalence, but it does not contain the technical performance study details you're asking for.

Here's why and what can be inferred:

• Acceptance Criteria and Reported Device Performance: Not provided in this regulatory letter. Substantial equivalence typically means the new device performs at least as well as the predicate device, but specific quantitative metrics are not detailed here.
• Sample size, data provenance, ground truth, adjudication, MRMC, standalone, training set details: These are all elements of a detailed performance study, which would be contained in a separate submission report to the FDA, not in the clearance letter itself.

To obtain the information you're looking for, you would generally need to refer to the original 510(k) submission documentation, which is often much more extensive than the clearance letter.

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The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification. And Images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic operations.

QXLink is PACS (Picture Archiving and Communication System) software for radiologist and physician doctor. QXLink enables images such as x-ray to be stored electronically and viewed on screens. QXLink conforms to the DICOM standards to allow the sharing of medical information with other digital Imaging system. Also, QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components provide functions for performing operations related to image manipulation, enhancement or quantification. And images may be acquired from imaging devices such as CR, CT, MR and other devices. QXLink consists of QXLink Server and QXLink Viewer and the main functions of QXLink are as follows.

This 510(k) submission (K092021) for the device "QXLink" (Picture Archiving and Communication System - PACS) does not contain information regarding a study to prove the device meets specific acceptance criteria.

The document is a 510(k) Summary and the associated FDA clearance letter, which focus on demonstrating substantial equivalence to predicate devices rather than presenting the results of a performance study with defined acceptance criteria.

Therefore, I cannot provide the requested table and information about a study proving acceptance criteria. The 510(k) summary only outlines the device's functions and states its substantial equivalence to other PACS devices.

Here's an explanation of why the requested information is absent from this specific document:

• Type of Submission: This is a 510(k) notification, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device).
• Focus of 510(k): The primary focus of a 510(k) is to establish "substantial equivalence" to a predicate device. This is often achieved by comparing technical characteristics, indications for use, and safety/performance data (if available and deemed necessary by the FDA for the particular device type).
• PAC System Nature: For a Picture Archiving and Communication System (PACS) like QXLink, the "performance" typically relates to its ability to correctly accept, transfer, display, store, and process medical images according to industry standards (like DICOM) and its advertised functionalities. These functionalities are usually validated through various software testing methods (e.g., unit testing, integration testing, system testing, user acceptance testing) which are part of a quality management system, but the detailed results of such validation are generally not included in the public 510(k) summary.
• Lack of Clinical Study: A PACS system, particularly one not intended for mammography, often doesn't require a clinical study with human patients to demonstrate its performance for 510(k) clearance, especially if it's functionally similar to already cleared predicate devices. The "performance" in this context is more about software functionality and adherence to standards than diagnostic accuracy from a clinical perspective.

In summary, the provided document details the description of the device, its intended use, and its comparison to predicate devices for the purpose of 510(k) clearance, but it does not include a specific study or explicit acceptance criteria for its performance in the way a diagnostic AI device would.

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