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The intended use of the fourSight ViewTool is for the acceptance, transfer, display, storage, and digital processing of ultrasound images, including image manipulation and quantification.

The ViewTool is used to view volumes and images, to store and print images, and to make measurements on images using a personal computer. The software is user-installable. The images are acquired by ultrasound systems using standardized formatting and are transferred from the ultrasound system to the PC hosting the ViewTool software by CD-ROM.

This 510(k) summary for the fourSight ViewTool image viewer does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving device performance. The document functions as a summary of the device's characteristics and its substantial equivalence to predicate devices, rather than a detailed report of validation studies.

Here's an analysis of the information that can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given 510(k) summary. The document focuses on regulatory classification, device description, and comparison to predicate devices, not specific performance metrics or acceptance criteria derived from a validation study.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. There is no mention of a test set, its size, or the provenance of the data used for any testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. Since no specific test set or ground truth establishment is described, details about experts are absent.

4. Adjudication Method for the Test Set

This information is not provided. No adjudication method is mentioned as there's no described test set or ground truth establishment process that would necessitate it.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study and its results, including any effect size on human reader improvement with AI assistance, are not mentioned or described. The device is an image viewer and not directly an AI-assisted diagnostic tool as described in this summary.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

A standalone performance study of an algorithm is not described. The device is an image viewer for displaying and manipulating ultrasound images, implying human interaction.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not specify any type of ground truth used, as it doesn't detail any performance study that would require establishing ground truth.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a training set, as the document doesn't describe the development or validation of a machine learning or AI algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. As no training set or ground truth for one is mentioned, the method of its establishment is also absent.

Summary of Device and Information Provided:

• Device Name: fourSight ViewTool image viewer
• Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Division
• Intended Use: Acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound images. Image manipulation and quantification.
• Device Description: Software used to view volumes and images, store and print images, and make measurements on images using a personal computer. Images are acquired by ultrasound systems and transferred via CD-ROM.
• Regulatory Classification: 21 CFR 892.2050 Picture Archiving and Communications System (Class II).
• Predicate Devices: ACUSON Antares ultrasound systems (K050034) and CSV12 Viewer Software (K022896).
• Basis for Clearance: Substantial equivalence to predicate devices, indicating that it performs similarly and does not raise new questions of safety or effectiveness.

Conclusion:

The provided 510(k) summary for the fourSight ViewTool image viewer is a regulatory document focused on demonstrating substantial equivalence to pre-existing devices. It outlines the device's intended use and technological characteristics in comparison to predicates. It does not contain the detailed validation study information, performance metrics, acceptance criteria, or ground truth methodologies that your request specifies. For such information, one would typically need to consult a more comprehensive validation report, clinical study summaries, or test protocols, which are not included in this particular 510(k) summary.

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