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The MH-246R Balloon Sheath for female reproductive tract is designed to be used with the Olympus Ultrasonic Probe UM-2R/UM3R for intraluminal ultrasonic imaging of the female reproductive tract.

The MH-246R Balloon Sheath for female reproductive tract consists of two sections - insertion section and connector section. The insertion section is constructed of a balloon with the light shielding cover, insertion tube, and adapter. The connector section consists of a connector body, probe locking ring, sheath locking ring, and irrigation port.

The insertion section is connected to the connector body through a sheath locking ring, while the ultrasonic probe is inserted into the balloon sheath through a probe locking ring. The water filled syringe is connected to the irrigation port via an extension tube and three-way stopcock. The insertion section with the balloon will be provided sterile and intended for single use only. The connector section can be reused after proper cleaning and sterilization as outlined in the instruction manual.

This document primarily focuses on the Olympus MH-246R Balloon Sheath for female reproductive tract use, specifically its 510(k) summary and FDA clearance. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a device with no AI/software component. Therefore, most of the requested information regarding AI performance and studies is not applicable.

However, I can extract the relevant information that is present:

Device Name: Olympus MH-246R Balloon Sheath (for female reproductive tract)

Intended Use: Designed to be used with the Olympus Ultrasonic Probe UM-2R/UM3R for intraluminal ultrasonic imaging of the female reproductive tract.

General Safety Statement: When compared to the predicate devices, Olympus MH-246R Balloon Sheath does not incorporate any significant change in method of operation, material, or design that could affect the safety or effectiveness.

Since there is no AI component, the following questions are not applicable to the provided text.

1. A table of acceptance criteria and the reported device performance: Not applicable (no AI/software component).
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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