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S595 Intra Oral Camera

This document is a 510(k) summary for the Sopro 595 Intra Oral Camera. It states that the device is substantially equivalent to other marketed intra-oral cameras and does not provide specific acceptance criteria or a study proving the device meets them.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence based on design, technology, specifications, and intended use, rather than presenting a performance study with detailed acceptance criteria.

Specifically, the document states:

• "SOPRO feels the S595 Intra Oral Camera is substantially equivalent to the many marketed devices already in commercial distribution."
• "The design of the S595 is virtually identical to the comparative devices, which are listed and displayed in Exhibit 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same, SOPRO feels that these minor differences have no impact on the safe use and/or effectiveness of the device."

This indicates a comparison to predicate devices rather than a standalone performance study with defined acceptance criteria and statistical analysis.

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