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The Biosense Webster Flower High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or pacing only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

The Flower High-Density Mapping Catheter is a 7 Fr diagnostic, multi-electrode electrophysiological mapping catheter designed for diagnostic electrogram recording and pacing in the heart. It has a unique distal multi-spine array of five 3 Fr 1.5 cm long spines. Model D-1245-01 has 20 electrodes evenly spaced 4 mm apart on all spines, whereas Model D-1245-02 has the electrodes spaced 2, 0, and then 2 mm in a star-like pattern that presents the 20 multiple electrodes in a two-dimensional array. The spines are pressed against the heart endocardium where they open into a star-like pattern that maps areas of the heart endocardium to detect various arrhythmias. A tube with a Luer connector on the proximal end provides an open lumen along the entire length of the catheter for continuous delivery of anticoagulation fluid. The catheter is controlled by a handle at the proximal end that activates or retracts the spines and/or deflects the catheter. The catheter is connected to appropriate recording equipment.

The provided text describes a 510(k) summary for the Flower High-Density Mapping Catheter. The document does not contain acceptance criteria or a detailed study proving the device meets specific performance criteria in a quantitative manner as typically expected for medical device approvals.

The performance data section broadly states: "The Flower High-Density Mapping Catheter underwent bench testing and was tested under simulated use conditions in animals and it passed all intended criteria in accordance with appropriate test criteria and standards. In addition, this catheter has been successfully employed in 80 clinical cases in humans to date with no reports of patient injury or death."

This indicates that general test criteria and standards were met, and clinical experience was observed, but specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and the detailed results demonstrating achievement of these criteria are not provided in this summary.

Therefore, the requested information, which relies on explicit acceptance criteria and corresponding performance data, cannot be fully extracted from the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly stated in the provided summary. The summary mentions "all intended criteria in accordance with appropriate test criteria and standards" were passed, but does not list these criteria or the quantitative results.

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

   • Test Set Sample Size: "80 clinical cases in humans" are mentioned.
   • Data Provenance: The 80 clinical cases are Human data. The country of origin is not specified, nor is whether the data was retrospective or prospective. Animal studies were also conducted, but their sample size is not stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. The summary states the catheter is used for "obtaining electrograms in the atrial and ventricular regions of the heart" for detection of various arrhythmias, implying expert interpretation, but details on ground truth establishment are absent.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided.

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: This is not an AI/software device. The description is of a physical mapping catheter. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI/software device. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The summary implies that the catheter facilitates the detection of "various heart arrhythmias" by "display, analysis, and interpretation" of electrical signals, which would typically involve expert interpretation. However, the specific methodology for establishing ground truth (e.g., confirmed arrhythmia diagnosis through expert consensus, correlation with other diagnostic methods, or pathology) is not detailed.

8. The sample size for the training set: This is not an AI/software device, so a training set in the AI sense is not applicable. The "80 clinical cases" refer to usage experience rather than a training dataset for an algorithm.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/software device with a distinct training set.

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