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The MH-246R Balloon Sheath for bronchial use is designed to be used with the Olympus Ultrasonic Probe UM 2R/3R for intraluminal ultrasonic imaging of the upper airways and tracheobronchial use.

The MH-246R Balloon Sheath for bronchial use 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 in 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.

The provided text describes a 510(k) submission for the Olympus MH-246R Balloon Sheath, a medical device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Identification: Device name, common name, classification, predicate device, and submitter information.
• Intended Use: For intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree when used with specific Olympus ultrasonic probes.
• Device Description: Details on its components (insertion section, connector section) and how it's used with other equipment (ultrasonic probe, syringe).
• Safety Statement: A general claim that it doesn't incorporate significant changes affecting safety or effectiveness compared to the predicate.
• FDA Clearance Letter: Confirmation of substantial equivalence to a predicate device and permission to market.
• Indications for Use: Reiterates the intended use.

Therefore, I cannot provide the requested information in a table or describe a study, as it is not present in the provided text.

To answer your request, I would need a document that includes detailed performance specifications, acceptance criteria, and the results of specific studies (e.g., bench testing, clinical trials) that evaluate the device against those criteria.

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