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The Agilis™ NxT Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Agilis NxT Steerable Introducer consists of a steerable sheath, plastic dilator and stainless steel guidewire, which is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. It is an 8.5F asymmetrical bi-directional steerable introducer with a large curl at the distal tip and a useable length of 71 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a guidewire. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle is equipped with a rotating collar to deflect the large curl 90° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.

The provided text is a 510(k) summary for the Agilis™ NxT Steerable Introducer. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about acceptance criteria and a study proving the device meets those criteria in the format requested.

Specifically:

• No detailed acceptance criteria table: The document states "Results of the testing demonstrate that the Agilis™ NxT Steerable Introducer design meets the product specification and intended use," but it doesn't list the specific performance metrics or their acceptable limits.
• No specific study results: It mentions "Bench testing of the Agilis™ NxT Steerable Introducer was performed to verify the device modification," but doesn't provide any quantitative results or a breakdown of the study methodology (sample sizes, ground truth establishment, etc.).
• No information on clinical studies: The document focuses on "non-clinical testing" (bench testing) and substantial equivalence. There is no mention of human reader studies (MRMC), standalone algorithm performance, or clinical trial data.
  Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or stated from the document, and what is missing:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not specified.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The testing was "bench testing," meaning it was likely laboratory-based and not involving human data or clinical scenarios.

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 testing was "bench testing" of a physical medical device (introducer catheter), not a diagnostic or AI-driven device requiring expert-established ground truth from images or other patient data. Ground truth would be based on engineering specifications and physical measurements.

4. Adjudication method for the test set

• Not applicable for bench testing of a physical device.

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. The document describes "non-clinical testing" (bench testing) of an introducer catheter. It does not involve AI or human readers.

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

• No. This is a physical medical device, not an algorithm, so this is not applicable.

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

• For "bench testing" of the Agilis™ NxT Steerable Introducer, the ground truth would be based on engineering design specifications and objective physical measurements (e.g., steerability angles, hemostasis valve integrity, material strength, radiopacity). This is inferred from the nature of the device and testing mentioned.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable. (See #8)

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