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Used for arterial and venous embolization in the peripheral vasculature.

The Flipper® Detachable Embolization Coil (Inconel) is used for arterial and venous embolization procedures in the peripheral vasculature. The device is supplied sterile and intended for one-time use. The embolization coil is pre-loaded in a shipping cannula. The coil is constructed of Inconel and has a coil wire diameter of 0.035 inches. It is available in a curled shape. The emboli size range is 3 to 8 mm. The embolization coil includes synthetic fibers evenly placed down the length of the coil. The device is introduced to the target vessel using an angiographic catheter (sold separately) and deployment is achieved when the threads between the coil and the Flipper® Detachable Coil Delivery Wire are unscrewed.

The acceptance criteria and study detailed in the provided text for the Flipper Detachable Embolization Coil (Inconel) are focused on the device's physical performance characteristics rather than diagnostic accuracy or human-in-the-loop performance. Therefore, many of the requested fields related to AI/ML or diagnostic performance studies cannot be fully addressed.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Testing data are presented to demonstrate that the Flipper® Detachable Embolization Coil (Inconel) meets applicable design and performance requirements." but does not provide specific quantitative acceptance limits or detailed test results within this summary.

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

The document does not specify the sample sizes (number of coils/tests) used for each of the performance tests. The data provenance is Cook Incorporated's internal testing. The tests are "retrospective" in the sense that they were performed on manufactured devices prior to submission for clearance, but not in the context of analyzing existing clinical data.

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

Not applicable. The "ground truth" for these performance tests is determined by engineering specifications and objective measurements, not expert consensus as would be typical for diagnostic devices.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements against predefined engineering standards, not subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is an embolization coil, and the provided documentation focuses on its physical and functional performance, not diagnostic imaging or human interpretation.

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

No, a standalone (algorithm only) performance study was not done. This is a medical device (embolization coil), not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests (e.g., Coil Deformation, Wire Tensile Strength) would be defined by the pre-established engineering specifications and physical characteristics of the device deemed safe and effective for its intended use. This is based on engineering specifications and objective physical measurements, not expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm, so there is no training set.

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

Not applicable. This device is not an AI/ML algorithm, so there is no training set or ground truth to establish for it.

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