Search Results

The Sedat Flamingo is indicated for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

The Sedat Flamingo inflation device is a single-use, sterile, and ergonomically designed inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). The manually operation of the FLAMINGO is achieved by the manipulation of a grip handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the button locks located on device.

The provided text is a 510(k) summary for the Sedat Flamingo Angiographic injector/syringe. The document explicitly states: "H. Summary of Clinical Tests (Not Applicable)." and lists "G. Summary of Non-Clinical Tests Mechanical testing was presented."

Therefore, a study demonstrating the device meets acceptance criteria via clinical tests, multi-reader multi-case studies, independent standalone algorithm performance, or using experts to establish ground truth is not applicable based on this document. The device's substantial equivalence was established through non-clinical mechanical testing and comparison to a predicate device.

Here's an breakdown of the requested information based on the provided text:

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

The document does not specify quantified acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it relies on substantial equivalence to a predicate device and mechanical testing.

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 clinical test set or data provenance from clinical data is mentioned for this 510(k) submission.

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

Not applicable. No clinical ground truth or experts were used for this 510(k) submission.

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

Not applicable. No clinical test set or adjudication method is mentioned for this 510(k) submission.

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.

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

Not applicable. This device is a mechanical inflation device, not an algorithm.

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

Not applicable in a clinical sense. The "ground truth" for this device's performance was established through mechanical testing and comparison to a predicate device's design, materials, and function.

8. The sample size for the training set

Not applicable. No training set is mentioned for this 510(k) submission.

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

Not applicable. No training set is mentioned for this 510(k) submission.

Ask a specific question about this device