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The Portaclamp® Flex is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.

The Portaclamp® Flex is an aortic clamping device composed of a detachable, reusable handle and a single-use, disposable clamp. It is designed to be used through a standard thoracic port to clamp the aorta during minimally invasive cardiac bypass procedures. The Portaclamp Flex consists of a flexible guide wire, two jaws that are passed over the guide wire and positioned on each side of the aorta, and a mandrel that is slid along the length of the jaws to compress the jaws and clamp the aorta.

The provided text is a 510(k) summary for the Portaclamp® Flex, a vascular clamp. However, it does not contain information on acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth, expert opinions, or statistical analysis typically associated with AI/algorithm performance studies.

The document focuses on demonstrating substantial equivalence to predicate devices for mechanical characteristics and intended use, rather than the performance of an AI or algorithm.

Therefore, I cannot provide details on the following based on the provided text:

• A table of acceptance criteria and reported device performance (for an AI/algorithm)
• Sample sizes used for test/training sets or data provenance
• Number of experts or their qualifications
• Adjudication method
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used
• How ground truth was established

The current document describes a traditional medical device (a vascular clamp), not an AI/algorithm-based device, and therefore the requested information regarding AI/algorithm performance studies is not present.

If you have a different document describing an AI/algorithm-based medical device, please provide that, and I can then attempt to extract the requested information.

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The Portaclamp™ is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.

The Portaclamp™ is a disposable aortic clamping device that is designed to be used through a standard thoracic port to clamp the aorta during minimally invasive cardiac bypass procedures. The Portaclamp™ consists of a flexible guide wire, two jaws that are passed over the guide wire and positioned on each side of the aorta. and a mandrel that is slid along the length of the jaws to compress the jaws and clamp the aorta.

The provided text describes a medical device, the Portaclamp™, and its substantial equivalence to predicate devices, but it does not contain the specific information requested in the prompt regarding acceptance criteria and a study that quantitatively proves the device meets those criteria.

Here’s a breakdown of what the document does mention and what is missing:

1. Table of acceptance criteria and the reported device performance

• Missing. The document only states "Information submitted in this premarket notification for the Portaclamp™ includes results of biocompatibility testing, in vitro performance testing, cadaver testing and clinical experience." It does not provide specific acceptance criteria (e.g., "Device must achieve a clamping force of X Newtons") or the corresponding reported performance values.

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

• Missing. The document mentions "cadaver testing and clinical experience" but provides no details on sample size, study design (retrospective/prospective), or data provenance.

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)

• Missing. The concept of "ground truth" as typically applied to AI performance evaluations is not present in this 510(k) summary for a physical medical device like a clamp. Clinical evaluations for such devices typically focus on safety and effectiveness outcomes.

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

• Missing. Not applicable to this type of device submission as it doesn't involve subjective assessment of images or data by multiple experts for 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

• Missing. This is entirely inapplicable as the Portaclamp™ is a physical surgical device, not an AI-assisted diagnostic tool for human readers.

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

• Missing. This is entirely inapplicable as the Portaclamp™ is a physical surgical device, not an algorithm.

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

• Missing. As mentioned above, the concept of "ground truth" as related to AI/diagnostic performance is not applicable here. Performance is typically assessed through measures like successful clamping, absence of tissue damage, durability, etc.

8. The sample size for the training set

• Missing. This is entirely inapplicable as the Portaclamp™ is a physical surgical device, not an AI algorithm that requires a training set.

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

• Missing. This is entirely inapplicable as the Portaclamp™ is a physical surgical device, not an AI algorithm that requires a training set.

In summary, the provided 510(k) summary for the Portaclamp™ is a regulatory document focused on demonstrating substantial equivalence to existing predicate devices. It mentions various types of testing (biocompatibility, in vitro, cadaver, clinical experience) but does not delve into the detailed quantitative performance metrics, acceptance criteria, sample sizes, or expert adjudication methods that would be relevant for evaluating the performance of an AI/diagnostic device as requested in the prompt.

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