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The 15 French TandemHeart Arterial Cannula Set (15 Fr. THAC) is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The cannula introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

The 15 French TandemHeart Femoral Arterial Cannula Set consists of two components, as shown in Figure 1: a 15 Fr. Femoral Arterial Cannula and a 10 Fr. Introducer. The device is intended to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal circulatory support equipment. The product is intended to be single patient, single use, sterile device.

The cannula has multiple side holes in addition to the tip opening for unimpeded flow of blood at the distal end and a vented barbed fitting at the proximal end to enable the connection of 3/8" tubing. Radiopaque markers are embedded at the distal tip of the cannula, and the cannula body is wire-reinforced for visualization under fluoroscopy. Insertion depth markings have been incorporated in the cannula body working length from 5 to 17 cm measured from the distal tip.

The cannula includes a suture wing to provide a means for securing the cannula to the patient and a stop component to minimize cannula insertion depth beyond its working length. Printing on the proximal region of the cannula indicates the area where a clamp should be applied if needed during the set-up or removal process.

The 10 Fr. introducer is provided to facilitate placement of the arterial cannula, within the target vessel, and is designed with a tapered distal tip. The introducer proximal end contains a luer hub to aid in the removal of the introducer body is also constructed of a radiopaque material for visualization under fluoroscopy.

The introducer includes a hemostasis cap that provides the interface between the cannula proximal connector and introducer body. The hemostasis cap aids in minimizing blood loss during the insertion of the cannula/introducer assembly into the target vessel.

This submission K133293 describes a medical device, the 15 French TandemHeart Femoral Arterial Cannula Set, and its substantial equivalence to predicate devices, but it does not include a study that defines or demonstrates acceptance criteria in the manner requested (e.g., using performance metrics like sensitivity, specificity, or accuracy based on human-AI comparison).

The document details non-clinical performance testing conducted to show substantial equivalence for a physical medical device (cannula), not a diagnostic algorithm or AI-powered system that would typically have acceptance criteria presented as performance metrics against ground truth.

Therefore, for your specified questions, I can only provide information based on the type of testing described in the document, which focuses on physical and functional characteristics of the cannula.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document states that "All performance tests were conducted on both the 15 French TandemHeart Femoral Arterial Cannula Set and the applicable control device... Based on the performance test results, the TandemHeart Femoral Arterial Cannula Set was found to meet the established design input requirements as well as to perform comparably to the predicate devices."

The acceptance criteria are implicitly defined by "established design input requirements" and "perform comparably to the predicate devices." No numerical targets or specific performance metrics are provided in the document for these tests, nor are the detailed results.

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

• Sample Size for Test Set: Not specified in the document. The testing involved "in-vitro" (laboratory) conditions not patient data.
• Data Provenance: In-vitro non-clinical testing. Not applicable for country of origin or retrospective/prospective as it's not clinical data.

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

This is not applicable as the "ground truth" for this type of device (cannula) is based on engineering specifications and physical performance measurements (e.g., flow rate, kink resistance, leak proofing) in a laboratory setting, not expert clinical interpretation of data.

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

Not applicable. This concept applies to expert consensus on clinical findings, not to in-vitro engineering tests.

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:

Not applicable. This is for AI-powered diagnostic devices, not a physical medical device like a cannula.

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

Not applicable. This is for AI-powered diagnostic devices, not a physical medical device.

7. The type of ground truth used:

The "ground truth" (or reference standard) would be the established engineering specifications for flow rates, material properties, and mechanical integrity tests (e.g., kink resistance, hemolysis limits, leak limits).

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device. The device design and manufacturing processes are developed based on engineering principles and prior device experience, not a data training set.

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

Not applicable. There is no "training set" or corresponding ground truth as this is not an AI/machine learning device.

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