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The Vesair Cystoscopic Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Vesair Cystoscopic Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.

The Vesair Cystoscopic Sheath is intended for use in visualizing the urethra and bladder as well as the establishment of a protective tract into the bladder to facilitate atraumatic insertion of catheters and instruments through the urethra.

The Vesair Cystoscopic Sheath Assembly includes a Visual Obturator, Sheath and the Vesair Single-Use Sterile Seal. The Sheath is provided non-sterile and requires cleaning and steam sterilization prior to use.

The provided text is a 510(k) premarket notification document for the "Vesair Cystoscopic Sheath." It primarily focuses on demonstrating substantial equivalence to a predicate device ("Guardian Urethral Sheath") rather than providing detailed acceptance criteria and study results for a new, AI-powered medical device.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance: The document mentions "in vitro performance tests" but does not provide specific acceptance criteria (e.g., specific thresholds for success in a test) or the quantitative results of these tests.
2. Sample size used for the test set and data provenance: No information is given about sample sizes for any "test set" in the context of device performance, nor is there any mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts and their qualifications for ground truth: This is irrelevant as the device isn't an AI/imaging device requiring expert ground truth for interpretation.
4. Adjudication method: Not applicable for this type of device and study.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a medical device, not an AI-assisted diagnostic tool.
6. Standalone (algorithm only) performance: Not applicable, as there is no algorithm or AI component mentioned.
7. Type of ground truth used: Not applicable in the context of a new AI/imaging device. The "performance data" mentioned are for mechanical and material properties.
8. Sample size for the training set: Not applicable, as there's no machine learning or AI training involved.
9. How ground truth for the training set was established: Not applicable for the same reason.

The document lists "In Vitro Performance Testing" as part of the performance data, including:

• Design Verification Testing / Simulated Use Testing
• Ship Testing
• Repeat Steam Sterilization Testing
• Accelerated Aging

However, it does not provide the details of these tests, their acceptance criteria, or the results. It concludes by stating that "Based upon the in vitro performance tests, the Vesair Cystoscopic Sheath has been shown to be substantially equivalent to the currently marketed Guardian Urethral Sheath K141252."

To summarize, the provided text describes a regulatory submission for a medical device (a cystoscopic sheath) and its claim of substantial equivalence to a predicate device, focusing on material, design, and sterilization comparisons. It is not an AI/software device and therefore does not have the types of performance data, ground truth establishment, or study methodologies that would be relevant to the questions posed.

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