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INOUE BALLOON™ A is intended for balloon aortic valvuloplasty (BAV) in patients with aortic stenosis.

INOUE BALLOON™ A is intended for the treatment of patients with aortic valvuloplasty (BAV). The device is transported over a guidewire as it is inserted through a percutaneous entry site and expanded with a predetermined amount of the diluted contrast medium by use of specified syringe with extension tube connected to the balloon inflation luer-lock hub. This results in the staged inflation of the balloon from hour-glass to barrel shape. The balloon is stretched and made thinner by pushing the inner tube in during passing thorough the introducer sheath. A radiopaque marker is provided for fluoroscopic positioning of the device across the valve.

This document is a 510(k) summary for the INOUE BALLOON™ A, a balloon aortic valvuloplasty catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on clinical performance directly. Therefore, it does not contain the detailed clinical study information typically provided for AI/ML-driven devices.

Here's an analysis based on the provided text, addressing your questions where possible and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a formal table with quantitative targets for each performance metric, as might be found for a new clinical efficacy study. Instead, it lists various physical performance tests and states that the device "meets specifications." The performance is implicitly deemed acceptable if it is "similar to that described by the predicate device" and indicates the device is "as safe and effective as the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

This document describes pre-clinical performance data, primarily engineering and material tests, not tests on human clinical data. Therefore, the concept of a "test set" and "data provenance" related to patient data (country, retrospective/prospective) is not applicable here. The "sample size" would refer to the number of devices tested for each performance characteristic, which is not specified in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth from medical experts is relevant for diagnostic claims, often involving image interpretation. This device is a medical instrument (balloon catheter), and its performance data focuses on physical and material properties. Usability evaluations would typically involve feedback from clinicians, but the number and qualifications are not specified in this summary.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to establish a robust ground truth from multiple expert interpretations, typically in diagnostic or screening studies. This document does not describe such studies.

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 an interventional medical device, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

For the pre-clinical performance tests, the "ground truth" would be established by the defined test methodologies and expected outcomes (e.g., a burst strength test has a quantitative "ground truth" for the maximum pressure it can withstand). For biocompatibility, the ground truth is adherence to ISO 10993-1 standards.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented here is a collection of pre-clinical performance data (i.e., laboratory and bench testing) designed to demonstrate that the INOUE BALLOON™ A functions as intended and is as safe and effective as its predicate device. This includes:

• Mechanical and Material Property Tests: Radio-detectability, surface integrity, corrosion resistance, peak tensile force, freedom from leakage, hub integrity, nominal size designation, guidewire compatibility, sheath compatibility, balloon minimum burst strength, balloon fatigue, inflation/deflation times, torquing, balloon preparation, bending, balloon over-inflation, and catheter removal.
• Biocompatibility Testing: According to ISO 10993-1 for short-duration contact with blood (

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