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the intended use the same

The design of the S-41 and S-41S is virtually identical to the comparative devices, which are listed and displayed in Exhibits 2 and 3.

The provided text is a 510(k) summary for the Del Medical Systems S-41 and S-41S Video Imaging System. This document is focused on demonstrating substantial equivalence to existing predicate devices (primarily the MSV-2000 and other legally marketed video imaging systems for medical use) rather than presenting a study with acceptance criteria and device performance results.

Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment can be extracted from the provided text.

The document explicitly states its purpose is to show substantial equivalence based on:

• Virtually identical design to comparative devices.
• Virtually identical technology.
• Very similar specifications.
• Same intended use.
• Belief that minor differences have no impact on safe use and/or effectiveness.

This type of submission typically relies on existing knowledge and safety records of the predicate devices rather than new performance studies with specific acceptance criteria as you've described.

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