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The SEDAT MYSHELL LITE is indicated for assisting, manipulating, and maintaining a seal around diagnostic/interventional devices with an outside diameter

The Sedat Myshell Lite consists of a variety of Y-connectors with a double silicone haemostatic valve within a reduce volume, well fitted for handling interventional procedures. The valve opening/closure mechanism could be activated by the thumb like a control button transforming the resilient valve in a variable geometry permitting to enlarge the valve opening of the silicone membrane. The interventionists make better adjustments for the seal introduction point and the size of the vascular instruments able to be introduced or removed to suit the individual pathology and anatomical conditions of the patient.

Here's an analysis of the provided text regarding the Sedat Myshell Lite device's acceptance criteria and the study used to demonstrate it:

Disclaimer: This device is a medical device (Y-connector with a double silicone haemostatic valve) and NOT an AI/algorithm-powered device. Therefore, many of the requested categories related to AI performance, ground truth, expert review, and training sets are not applicable or cannot be extracted from the provided 510(k) summary. I will highlight what information is present and what is missing based on the nature of this particular device approval.

Acceptance Criteria and Device Performance

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MYSHELL is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter

MYSHELL is an ergonomically designed y-connector/hemostatic valve that accepts materials up to 9F in size (

The provided text states that "The safety and efficacy of MYSHELL and its accessories... have been demonstrated," but it does not provide any specific acceptance criteria or details of a study verifying those criteria.

Therefore, I cannot populate the table or answer the specific questions about the study from the provided document. The submission is a 510(k) summary for a medical device (Y-Connector/Hemostatic Valve), which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results with acceptance criteria.

Information not found in the provided document:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance for the test set.
• Number of experts used to establish ground truth for the test set.
• Qualifications of experts.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Effect size (if MRMC was done).
• Whether a standalone performance study was done.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

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