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Vaginal Speculums are single use and shall be used to expose the interior of the vagina.

The MAI vaginal speculum is a non-metal (polystyrene), hand held device used to expose the interior of the vagina.

The provided text is a 510(k) summary for a vaginal speculum. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria, device performance studies, or any of the detailed study parameters requested in your prompt (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).

The 510(k) summary states:

• Description of Device: The MAI vaginal speculum is a non-metal (polystyrene), hand-held device used to expose the interior of the vagina.
• Intended use of the Device: To be used by medical professionals to expose the interior of the vagina to facilitate visualization during gynecological and obstetric procedures.
• Technical Characteristics: The MAI vaginal speculum has the same technological characteristics as and is substantially equivalent to the Leespec Disposable Vaginal Speculum (K021017), manufactured by ITL Corporation.

The letter from the FDA (sections 1 and 2) confirms the review of the 510(k) submission and the determination of substantial equivalence. This type of FDA clearance (510(k)) for Class II devices often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies with detailed performance metrics as might be seen for novel or higher-risk devices.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, and performance metrics because that information is not present in the provided text. The document focuses on establishing substantial equivalence based on technical characteristics to a predicate device, not on presenting novel performance data or clinical study results against predefined acceptance criteria.

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