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The Expro Elite and Sympro Elite snares are intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures include retrieval and/ or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system. This device is not intended for use in the coronary arteries or neurovasculature.

The Expro Elite and Sympro Elite snares consist of an 0.035" outer sheath and a moveable central core wire with a pre-formed loop on the distal end. The outer sheath acts as a lumen through which the central core wire slides. The snare loop is radiopaque and can be advanced out of and retracted into the outer sheath by advancing or retracting the central core wire while holding the sheath stationary. A sheath grip tab on the proximal end of the sheath aids the user as they manipulate the handle during snare deployment. The snares have a rocker switch locking mechanism handle that allows for secure capture of an item by locking the sheath and core wire together as one unit, which offers the operator flexibility in maneuvering an object.

The outer sheath profile of the Expro and Sympro models is 0.035" (0.889 mm) and they are capable of being advanced through the lumen of a 0.035" inner diameter catheter. The outer sheath comprises a tri-layer polymer shaft and the distal snare loop construction is a Nitinol core covered with a gold tungsten coil.

The Expro Elite snare consists of one helical shaped loop and the Sympro Elite snare consists of one, round loop with a 90° angle to the snare shaft. Both snares are available in five loop diameters - 5 mm, 10 mm, 15 mm, and 35 mm. The Expro models vary in maximum loop length (26 mm to 80 mm) depending on the loop diameter.

This document describes a 510(k) premarket notification for the Expro Elite Snare and Sympro Elite Snare devices. It does not pertain to an AI/ML medical device, but rather to a physical medical device (a snare for retrieving foreign objects). Therefore, many of the requested items related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this document.

However, I can extract the information relevant to the device's acceptance criteria and the studies performed to prove it meets them, based on the provided text.

Device Name: Expro Elite Snare, Sympro Elite Snare

Device Type: Medical Device (Physical Snare) - Not an AI/ML device.

Here's the information extracted from the document:

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

The document states: "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." However, the specific quantitative acceptance criteria and the precise numerical performance results for each test are not provided in this summary. Instead, it lists the types of tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes bench testing and biocompatibility testing of a physical device, not an AI/ML test set. Therefore, "sample size for the test set" in the context of data points/images is not applicable. The document does not specify the number of physical units tested for each bench test. Data provenance (country of origin, retrospective/prospective) is also not applicable as it's not a study involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/ML device relying on human expert annotation to establish ground truth.

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

Not applicable. This is not an AI/ML device requiring human adjudication of data.

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 is not an AI/ML device, and no MRMC study was performed. The document explicitly states: "Clinical testing was not performed."

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

Not applicable. This is not an AI/ML algorithm. The performance evaluation was of the physical device's mechanical and material properties.

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

For this physical device, the "ground truth" is defined by the engineering specifications and performance criteria established for the device's function (e.g., specific force thresholds, dimensional tolerances, material compatibility standards). The document indicates that the tests conform to established standards like ISO 10993-1 for biocompatibility.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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