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Use for visualization inside the human body to view surgical procedure(s), by physician.

The Indications for this device use is when medical practitioner needs visualization in order to view surgical procedures, gaining access either through a natural orifice or incision.

The design of SOLOS ENDOSCOPY made/marketed endoscopes K971996, K926166 is virtually the same as soopes approved for intended use for the purpose of visualization of surgical procedures.

The provided text is a 510(k) summary for a "Miniature Endo/Laparoscope" from Solos Endoscopy, Inc. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel safety and effectiveness through extensive clinical studies and acceptance criteria as might be seen for devices requiring Premarket Approval (PMA) or more rigorous 510(k) submissions.

Therefore, the information typically requested in your prompt (e.g., acceptance criteria, samples sizes for test and training sets, expert qualifications, MRMC studies, standalone performance) is not present in this type of submission.

Instead, the document asserts that:

• The device is substantially equivalent to legally marketed predicate devices (K932987, K931065, K926166, and others from various manufacturers).
• Physical characteristics are virtually the same, except for miniaturization.
• Intended use is virtually identical: "visualization of surgical procedures."
• Prior devices were accepted with respect to: performance specifications, composition, technology employed, biocompatibility, manufacturing, QC, physical testing, etc.
• Minor changes (miniaturization) have no impact on safety and/or effectiveness.

This type of 510(k) relies on the premise that if a new device is sufficiently similar to a legally marketed predicate device, it is also safe and effective for its intended use without requiring new, extensive clinical trials to prove performance against specific acceptance criteria.

Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text. The document is a regulatory approval letter and an executive summary of a 510(k) submission, not a study report detailing performance data against specific, quantitative acceptance criteria.

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