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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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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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Olympus MH-246R Balloon Sheath have been designed to be used with the Olympus Ultrasonic Probe UM-2R/UM-3R, for intraluminal ultrasonic imaging of the urinary tract.

The MH-246R Balloon Sheath for urinary 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 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 is a 510(k) Summary for the Olympus MH-246R Balloon Sheath. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity), study design, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested table or detailed answers to questions 1-9 based on the given input. The document is primarily a regulatory submission outlining the device's description and intended use for substantial equivalence, not a performance study report.

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The balloon sheath MH-246R is designed to be used with the Olympus Ultrasonic Probe UM-2R/3R for intraluminal ultrasonic imaging of the gastrointestinal tract wall and surrounding organs.

The MH-246R Balloon Catheter consists of two section 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 lock ring, sheath lock 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.

The provided text is a 510(k) summary for a medical device: the Olympus MH-246R Balloon Sheath. This document describes the device, its intended use, and states that it does not incorporate significant changes from predicate devices that would affect safety or effectiveness.

However, the summary does not contain any information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert involvement. These details are typically found in performance testing sections of a 510(k) submission, which are not present in this excerpt.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the study, as the necessary information is not provided in the input.

Ask a specific question about this device