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AspenView is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications). The main features of this software are storing acquired images, data management, image processing and image stitching.

AspenView software is designed for use by radiologists and radiology technicians for annotation in the X-ray images. The AspenView software is developed to use Aspen Imaging Flat Panel DR Detector and Aspen Imaging Healthcare Inc Image Viewer. The purpose of AspenView software is for the doctor to annotate X-ray images and then to print out with patient information or sent to another PACS system.

A client user needs to install AspenView first in the recommended PC environment. After installation, the client user chooses a DICOM format in the uploaded patient list to be annotated, and then annotation is written by user after reviewing of image chosen. After annotation has completed it can be printed out, saved or sent to another PACS system.

AspenView software includes an image stitching function to read multiple medical images at one time by stitching them to one image based on overlapping areas. It supports DICOM 3.0 which is standard of medical image format as well as Tiff and Raw images. It provides additional functions such as image retrieval, storage, and transmission.

The provided document is a 510(k) summary for the AspenView device. It outlines the general characteristics of the device and its claimed substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria, study design, or performance data that would be required to answer all parts of your request regarding the device's performance against acceptance criteria.

Specifically, the document states:

• "Safety testing and documentation was performed in accordance with IEEE 1012-2012, Standard for System and Software Verification and Validation. [AspenView-SVsR]" (Page 6)
• "Software information is provided in accordance with FDA guidance: 'The content of premarket submissions for software contained in medical devices.'" (Page 6)
• "Cybersecurity information is provided in accordance with FDA guidance: 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions'" (Page 6)

These statements indicate that studies and documentation were performed to demonstrate safety and effectiveness, but the actual results, the acceptance criteria for those results, and the details of how ground truth was established are not included in this summary.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be answered based on the provided text, and what remains unknown:

Acceptance Criteria and Device Performance:

The document does not provide a table of acceptance criteria or specific reported device performance metrics (e.g., sensitivity, specificity, accuracy) for a clinical performance study. It primarily focuses on the device's functional equivalence to its predicate.

Information that Cannot Be Extracted from the Provided Text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "Safety testing and documentation was performed," but the specific performance results and their corresponding acceptance criteria are not included in this 510(k) summary.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided, as details of specific performance studies are absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided. The device description mentions annotation features, but not AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated or detailed. The primary function described is image management, processing, and stitching, not an AI diagnostic algorithm requiring standalone performance evaluation in the typical sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

Based on the provided text, the device (AspenView) is primarily a Medical Image Management and Processing System, including image annotation, measurement, processing, and stitching. It is stated to be substantially equivalent in function and intended use to its predicate device (EConsole1). The document asserts that "There are no significant differences between AspenView and the predicate device that would adversely affect the use of the product."

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