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The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for use in venting the left heart during cardiopulmonary bypass surgery.

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is designed for use in venting the left heart during cardiopulmonary bypass surgery.

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is equipped with a pressure monitoring line, which allows measurement of left ventricular pressure.

This submission package does not contain the level of detail required to complete the requested table and provide specific information on acceptance criteria and study design elements like sample sizes, ground truth establishment, or expert qualifications. The provided document is a 510(k) summary for a medical device (24 Fr. Left Heart Vent Catheter w/ Pressure Monitoring Line) seeking substantial equivalence to predicate devices.

Here's why and what can be pieced together:

Key Takeaways from the Document:

• Substantial Equivalence: The primary goal of this submission is to demonstrate that the new device is substantially equivalent to already legally marketed predicate devices. This means it has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness.
• No Clinical Trials: 510(k) submissions, especially for devices seeking substantial equivalence based on minor modifications, often rely heavily on bench testing and comparison to predicates rather than extensive clinical studies with human participants. This is evident as no mention of human subject data, clinical trials, or expert reader studies (MRMC, standalone AI performance) is present.
• Bench Testing: The document explicitly states: "The biocompatibility rationale and in vitro bench testing demonstrated that when compared to the predicate devices, the 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed devices. The in vitro bench testing included analysis of: kink testing, clamp testing, flexibility testing, burst, leak testing, pull testing and pressure monitoring capability."

Therefore, many sections of your request cannot be directly answered from this document.

Here's an attempt to populate the table and answer the questions based on the available information, noting where information is absent:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any of the bench tests.
• Data Provenance: The tests are in-vitro bench tests, not involving human or animal subjects. The location of the testing is not specified, but it was conducted by Medtronic, Inc. in the USA. Given the nature of a 510(k) for device modifications, these would be considered retrospective in the sense that the new device's performance is compared against known characteristics or specifications of existing predicate devices and general standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable (N/A) as the study involved in-vitro bench testing, not expert interpretation or clinical assessment.

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

• This information is not applicable (N/A) as the study involved in-vitro bench testing, not subjective assessment requiring adjudication.

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

• No MRMC study was done. This is a 510(k) for a physical medical device (catheter), not an AI-enabled diagnostic tool. Therefore, concerns about human reader improvement with AI are not applicable (N/A).

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

• No standalone algorithm performance study was done. This is a 510(k) for a physical medical device, not an AI algorithm. Therefore, concerns about standalone algorithm performance are not applicable (N/A).

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

• The "ground truth" for the bench tests would be the pre-defined engineering specifications, material standards, and performance characteristics of the predicate devices. For instance, the "ground truth" for burst pressure would be a certain pressure threshold the device must withstand, derived from safety standards and predicate device performance. It is based on engineering specifications and established material/device performance standards.

8. The sample size for the training set

• This is not applicable (N/A). This device is not an AI algorithm, and thus, there is no AI "training set."

9. How the ground truth for the training set was established

• This is not applicable (N/A) as there is no AI training set.

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