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The SQA V is a point-of-care, easy-to-use, electro-optical device with on-screen visualization and image freezing capabilities for semen analysis. The SQA V provides direct and calculated measurements for:

• total sperm concentration (TSC, millions/mL) .
• percent motility (%MOT) and % progressive motility (%PMOT) .
• % normal morphology (%MORPH) .
• motile sperm concentration (MSC, millions/mL) and progressive MSC (PMSC) ●
• . functional sperm concentration (FSC, millions/mL)

The SQA V is a point-of-care, easy-to-use, electro-optical device with on-screen visualization and image freezing capabilities for semen analysis.

This looks like a medical device submission, specifically a 510(k) for a "Sperm Quality Analyzer - Visual (SQA V)". However, the provided document is an FDA letter recognizing substantial equivalence, and an "Indications for Use" statement.

Crucially, this document does NOT contain the acceptance criteria, the study details, or the reported device performance. The FDA letter indicates the device has been found substantially equivalent to a predicate device, which means the company filed a submission with this information, but this specific excerpt does not include it.

To answer your request, I would need to see the actual 510(k) submission summary or a section detailing the performance study. This letter is simply the FDA's regulatory decision based on that submission.

Therefore, I cannot fill out the requested table and answer the specific questions because the necessary information is not present in the provided text.

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