Search Results

The 8Fr. Narrowflex Universal Intra-Aortic Balloon Catheter is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure

The device is a dual lumen percutaneously inserted Intra-Aortic IAB catheter, 8 Fr. in size, with two independent non-communicating lumens. The outer lumen is comprised of an inflatable bladder connected to the catheter distal tip and to the IAB tip outer surface. The inner lumen is comprised of a Luer adapter connected to the proximal end of the inner lumen and to the IAB tip inner surface. The IAB inner lumen is used for placement of the device with a guidewire and the outer lumen is used to shuttle helium gas to and from the inflatable bladder. The IAB is timed to inflate in the aorta during the diastolic relaxation of the heart and deflate during the systolic contraction of the heart, resulting in increased blood supply to the heart muscle and decreased work load for the left ventricle.

The provided text describes a 510(k) premarket notification for a medical device, the 8Fr. NarrowFlex Universal Intra-Aortic Balloon Catheter. The document assesses the substantial equivalence of the new device to a predicate device. However, it does not contain information about specific acceptance criteria, comprehensive study designs, or detailed performance data as would be typically found in a clinical trial report or a more extensive validation study summary.

Therefore, many of the requested items (sample size, data provenance, expert qualifications, adjudication method, MRMC study, effect size, standalone performance, ground truth details, training set information) cannot be extracted from this document because they are not present.

Below is a summary of the available information, noting where requested details are absent.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document implies acceptance criteria by stating that the new device has the “same exact technological characteristics as the predicate” and that test results “demonstrate that the device is substantially equivalent.” Specific numerical thresholds or acceptance ranges are not provided.

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

• Sample Size: Not specified. The document only mentions "tests" were conducted but does not provide details on the number of devices or data points included in these tests (e.g., number of balloons tested, number of inflate/deflate cycles).
• Data Provenance: Not specified. These appear to be laboratory performance tests, not clinical data from patients.

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

• Not Applicable. The "ground truth" in this context refers to laboratory performance metrics against a predicate device, not clinical diagnoses requiring expert consensus.

4. Adjudication method for the test set

• Not Applicable. As the tests are performance comparisons against a predicate, there is no expert adjudication process described.

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 document pertains to an intra-aortic balloon catheter, a physical medical device. It does not describe an AI-powered diagnostic tool, therefore, MRMC studies and AI assistance are not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" in this context is the performance characteristics of the legally marketed predicate device. The new device's performance was compared against these established characteristics through laboratory testing.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an algorithm that requires a training set.

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

• Not Applicable. This is a physical medical device, not an algorithm that requires a training set.

Ask a specific question about this device