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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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The Radius Snare is intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.

The Radius Snare is composed of two primary parts: an outer sheath tube and a core wire with a snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides. The outer sheath is a stainless steel coil with a PTFE overjacket. The stainless steel core is the same solid .0135" diameter stainless steel core wire in the FDA cleared Radius PTCA Guidewire. A stainless steel loop is soldered to the distal end of the core wire. The Radius Snare has loop sizes which range from 5 - 35 millimeters. The over-all length of the device is 150 centimeters. The Radius Snare will be packaged in a mylar/Tyvek pouch and ETO sterilized to SAL 10-2.

The provided text describes specific performance tests conducted on the Radius Snare device. However, it does not explicitly state numerical acceptance criteria for these tests, nor does it provide detailed results demonstrating the device meets specific criteria. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through design, materials, and function, and then lists the types of performance tests performed.

Therefore, for aspects like "Table of acceptance criteria and reported device performance," "sample sizes used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone study," "type of ground truth," "sample size for training set," and "how ground truth for training set was established," the information is not available within the provided text.

Here's a breakdown of what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on Available Text):

• Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
  • Not available. The document only mentions that "in vitro performance tests were performed," but does not specify the number of units tested or any details about data provenance.
• 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/Not available. The study described involves in vitro performance testing of the device's physical and mechanical properties, not an assessment of diagnostic performance that would require expert ground truth.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set:
  • Not applicable/Not available. As above, this is not a clinical study involving human assessment.
• 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:
  • No. This is not an AI-powered device, nor is an MRMC study described. The device is a medical snare used in interventional procedures.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  • Not applicable. This question pertains to AI/algorithm performance. The Radius Snare is a physical medical device. The "performance testing" referenced is for the device's mechanical and material properties.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc):
  • Not applicable/Not available in the context of clinical outcomes. For the in vitro performance tests, the "ground truth" would be established engineering or material science standards and specifications, but these are not detailed in the document.
• The sample size for the training set:
  • Not applicable. This refers to a machine learning context.
• How the ground truth for the training set was established:
  • Not applicable. This refers to a machine learning context.

In summary: The provided document is a 510(k) summary for a medical device (Radius Snare). It focuses on demonstrating substantial equivalence to predicate devices and lists types of in vitro performance tests conducted (Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence/Integrity, Biocompatibility). It explicitly states the sterilization method. However, it does not provide detailed acceptance criteria, specific test results, or any information related to clinical studies, human reader performance, or artificial intelligence algorithms.

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