Search Results

The inflation device is intended for single use while performing gastrointestinal (GI), gastrouterine (GU) and lacrimal duct balloon catheter dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.

The Atrion Medical Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger. a manometer to measure pressure and a connecting tube. The Device has a fluid capacity of 20 cc and an operating pressure range of vacuum to between 10 and 20 atm, depending on the manometer attached.

The provided text describes a medical device, the Atrion Medical Balloon Catheter Inflation Device, and its clearance through the 510(k) pathway. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

This document is a "Summary of Safety and Effectiveness" and a subsequent FDA Letter, both primarily focused on establishing substantial equivalence to a predicate device (Ryder International Urological Balloon Catheter Inflation Device). The safety testing mentioned refers to material compatibility with contrast solution, not the functional performance of the inflation device itself in a clinical or simulated clinical setting.

Therefore, I cannot populate the requested table or answer most of the questions using the provided text.

Here's what can be extracted based on the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
Not provided in the document. The "safety testing" mentioned refers only to material tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No clinical or performance testing requiring expert ground truth is described.

4. Adjudication method for the test set:
Not applicable. No clinical or performance testing requiring adjudication is 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 device is a mechanical inflation device, not an AI-assisted diagnostic tool, and no MRMC studies are mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used:
For the "Summary of Safety Testing," the ground truth used was compliance with "USP guidelines" for material testing with contrast solution. No clinical ground truth is mentioned.

8. The sample size for the training set:
Not applicable. This is a medical device, not an AI model, and no training set is mentioned.

9. How the ground truth for the training set was established:
Not applicable. This is a medical device, not an AI model.

In summary: The provided FDA submission documents focus on comparing the Atrion Medical Balloon Catheter Inflation Device to a predicate device for substantial equivalence, with an emphasis on technological characteristics and material safety. They do not contain the type of performance study data, acceptance criteria, or ground truth information typical for diagnostic or AI-driven medical devices.

Ask a specific question about this device