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The Cosine-10 Diagnostic Catheter is indicated for electrophysiological mapping (stimulation and recording) of cardiac structures, including in the coronary sinus.

The Cosine-10 Diagnostic Catheter is a sterile, single-use, steerable decapolar mapping catheter with a bidirectional deflecting tip intended for electrophysiological mapping of cardiac structures (i.e., stimulation and recording). The catheter contains 10 electrodes spaced in 5 pairs, including a distal dome electrode. Two electrode spacing configurations are available: 2-8-2 (AFR-00017) or 2-5-2 (AFR-00018). All catheter electrodes may be used for recording or stimulation. The catheter can be used with a compatible introducer sheath (7.5Fr minimum).

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the Cosine-10TM Diagnostic Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain the detailed acceptance criteria or the specific study results related to AI/algorithm performance that your request asks for.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or detailed performance metrics from a study related to an algorithm's diagnostic accuracy (e.g., sensitivity, specificity, AUC). It only states that "all acceptance criteria were met" for various engineering and biological tests (sterilization, biocompatibility, design verification, etc.).
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned, as this device is a physical catheter, not an AI/software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical diagnostic catheter.
7. The type of ground truth used: Not applicable in the context of an AI study. The document mentions "electrophysiological mapping" and "stimulation and recording" as the device's function.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

The document describes the device, its intended use, and its similarities and differences to a predicate device (DECANAV Mapping Catheter K231312). It states that "Safety and performance testing applicable to the subject device was completed to ensure it performs as intended per product specifications and requirements/user needs." The list of completed testing includes:

• Sterilization validation and adoption
• Biocompatibility
• Design verification
• Packaging validation
• Design validation
• Pre-clinical animal testing

These are standard engineering and biological tests for a physical medical device, not studies of an AI's diagnostic performance. The document concludes that "No questions of safety or effectiveness are raised as a result of the testing. The subject device is as safe and effective as the predicate device and the subject device is considered substantially equivalent to the predicate device."

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