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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 <9F (<.098") used in interventional angioplasty procedures.

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

Note: The primary "acceptance criteria" for a 510(k) device like this is demonstrating substantial equivalence to a previously cleared predicate device. The performance is assessed against the predicate's known safety and effectiveness through comparisons of intended use, design, materials, and function, often supported by bench testing. Specific quantitative clinical performance metrics (like sensitivity, specificity, accuracy) are typically not required or reported for Class II devices gaining clearance via substantial equivalence if their function is well-understood and similar to existing devices.

Study Details (Applicability to AI/Algorithm-Powered Devices)

1. Sample size used for the test set and the data provenance:

   • N/A (Not an AI Device): There is no "test set" in the context of an algorithm or AI model for this physical medical device. The evaluation relied on a comparison to a predicate device and bench testing.
   • Data Provenance: Bench testing would likely be performed in a laboratory setting by the manufacturer (Sedat, France).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A (Not an AI Device): No expert-established ground truth for an algorithm's test set. The "ground truth" for this device's performance would be its functional performance against engineering specifications and its ability to perform its intended mechanical function (maintaining a seal) during bench testing.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A (Not an AI Device): Not applicable as there is no human adjudication of an AI output for this device.

4. 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:

   • N/A (Not an AI Device): This is a physical Y-connector; it does not involve human readers or AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • N/A (Not an AI Device): Not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Technical Specifications/Bench Test Results (for mechanical device): The "ground truth" for this device would be its ability to mechanically meet its design specifications and functional requirements (e.g., integrity of the seal, valve opening/closure mechanism, material compatibility, pressure resistance, etc.) demonstrated through bench testing. It's not a diagnostic device requiring a clinical ground truth like pathology or expert consensus on patient conditions.

7. The sample size for the training set:

   • N/A (Not an AI Device): There is no training set for a physical medical device.

8. How the ground truth for the training set was established:

   • N/A (Not an AI Device): Not applicable.

Summary for this specific device:

The Sedat Myshell Lite is a physical medical device, not an AI or algorithm-powered one. Its regulatory clearance (510(k)) focuses on demonstrating substantial equivalence to an already legally marketed predicate device (Myshell device cleared under K040498).

The study that "proves the device meets the acceptance criteria" is outlined as "Bench performance testing." This testing would have confirmed that the device functions as intended and safely, similar to its predicate. The summary explicitly states: "Summary of Clinical Tests (Not Applicable)." This means that no human clinical trials were required or performed to demonstrate the device's safety and effectiveness for this 510(k) clearance, as its function is well-established through the predicate device and bench testing.

Therefore, questions pertaining to AI-specific evaluation metrics, training/test sets, expert adjudication, or MRMC studies are not relevant to this submission.

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