(123 days)
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: a stainless steel outer sheath tube and a stainless steel core wire with a loop snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides. 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 is packaged in a mylat/Tyvek pouch and ETO sterilized to SAL 10°.
The provided text describes a medical device, the Radius Snare, and its 510(k) submission to the FDA. However, the document does NOT contain information about acceptance criteria for performance metrics or a study detailing specific device performance against such criteria. The "Performance Testing" section states that modifications were assessed based on an FDA guidance document, but it does not present any quantitative performance data, sample sizes, or details about ground truth establishment.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's an analysis of what information can be extracted:
-
A table of acceptance criteria and the reported device performance
- Not Available. The document states that "Performance testing to assess the impact of the modifications was from the FDA guidance document 'Coronary and Cerebrovascular Guidewire Guidance' dated January 1995." It concludes that the device "meets the minimum requirements that are considered adequate for its intended use." However, it does not specify what those minimum requirements (acceptance criteria) were, nor does it present any specific performance metrics (e.g., retrieval success rate, deployment accuracy, force required, etc.) or a table comparing them to acceptance criteria.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document does not mention any sample sizes for testing, nor does it specify data provenance. It only refers to "Performance testing."
-
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. There is no mention of expert-established ground truth or any clinical study involving experts. The performance testing appears to be primarily bench or in-vitro testing based on device characteristics.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available. The concept of "adjudication" typically applies to clinical studies or assessments where human judgment is involved in determining outcomes or ground truth, which is not described here.
-
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 physical medical snare, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Available. Given the nature of the device (a snare for retrieving objects), the "performance testing" likely involved evaluating physical characteristics, retrieval forces, deployment, and material integrity against predetermined engineering specifications, rather than clinical ground truth like pathology or expert consensus. The specific metrics and how they constituted "ground truth" for the device's function are not detailed.
-
The sample size for the training set
- Not Applicable/Not Available. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of the provided document.
-
How the ground truth for the training set was established
- Not Applicable/Not Available. As above, no training set is relevant.
In summary, the provided document focuses on the regulatory submission and essential equivalence of a physical medical device based on design and general performance testing against a guidance document, rather than detailing a specific study with quantitative acceptance criteria and performance data for a diagnostic or AI-driven device.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).