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The Insight Endocardial Visualization System is intended to aid in the visualization of the coronary sinus, foramen ovale and other venous and cardiac anatomy, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart. The Insight is intended for use in the right heart only.

The Acumen Insight Endocardial Visualization System (Insight) is a single-use percutaneous catheter intended to aid in the visualization of the coronary sinus. foramen ovale and other venous side cardiac anatomy, provide temporary occlusion during a venogram, and to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

The provided text states that "additional device testing was not required" and does not describe any specific studies conducted for this 510(k) submission. Instead, it relies on substantial equivalence to predicate devices (K042381, K062084, K992631). Therefore, information regarding acceptance criteria, study design elements (sample size, ground truth, expert qualifications, adjudication methods), or AI-specific details (MRMC studies, standalone performance, training set) is not available in the given document.

1. A table of acceptance criteria and the reported device performance

No acceptance criteria or reported device performance data are provided in the document from a new study. The submission relies on substantial equivalence to predicate devices based on identical or substantially equivalent intended use, method of operation, construction, and materials.

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

Not applicable. No new device performance study was conducted as stated in the document: "As there is no change in the design of the device, additional device testing was not required."

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)

Not applicable. As no new device performance study was conducted.

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

Not applicable. As no new device performance study was conducted.

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 device is a medical catheter for visualization and delivery, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.

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

Not applicable. This device is a medical catheter and does not involve an algorithm with standalone performance.

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

Not applicable. As no new device performance study was conducted.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable. This device is not an AI/ML device that requires a training set.

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