(270 days)
PATH BGC is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
The PATH Balloon Guide Catheter (PATH BGC) is a dual coaxial lumen catheter consisting of an inner coil reinforced variable stiffness lumen and an outer braid reinforced variable stiffness lumen. A radiopaque marker is included at the tip of the catheter and at the distal and proximal ends of the balloon. A compliant balloon is mounted near the distal end of the catheter to provide vascular occlusion during angiographic procedures. The catheter has hydrophilic coating at the distal and proximal end. A bifurcated luer hub on the proximal end allows attachments for flushing and balloon inflation.
The provided document is a 510(k) Clearance Letter for a medical device (PATH BGC) and does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance against a clinical ground truth.
Instead, this document describes the device's physical characteristics, intended use, comparison to a predicate device, and bench testing, biocompatibility testing, and shelf-life testing to demonstrate performance and safety. These tests are common for physical medical devices and confirm that the device meets pre-defined engineering specifications, not clinical accuracy in diagnosis or treatment based on AI.
Therefore, I cannot fulfill the request for information regarding AI acceptance criteria and study details based on the provided text. The document explicitly states:
- Clinical Study: "Clinical study was not deemed necessary to demonstrate substantial equivalence." (Page 11)
- Animal Study: "Animal study was not deemed necessary to demonstrate substantial equivalence." (Page 10)
The "acceptance criteria" discussed in the document refer to engineering specifications and performance metrics for a physical catheter, such as dimensional accuracy, kink resistance, lubricity, mechanical strength, and biocompatibility.
To answer your request, if this were an AI-powered device, the information you're asking for would typically be found in a separate section detailing the AI algorithm's validation study, which is absent here.
Here's a breakdown of why each point of your request cannot be answered from the provided text:
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A table of acceptance criteria and the reported device performance:
- Not applicable for AI performance. The table provided (Table 2) lists bench tests for the physical catheter (e.g., Visual Inspection, Dimensional Inspection, Kink Resistance, Coating Lubricity, Radiopacity, etc.). The "results" column simply states "Pass – all samples met the pre-determined acceptance criteria," without providing specific numerical performance data against a clinical ground truth.
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Sample sizes used for the test set and the data provenance:
- Not applicable for AI performance. The "samples" referred to in Table 2 are physical units of the catheter device, not data sets for an AI algorithm. There is no mention of data provenance for AI.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no AI component, and thus no need for experts to establish a "ground truth" for clinical interpretation using the device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to clinical adjudication of AI outputs, which is not present.
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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. No MRMC study was performed as no AI assistance is described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No standalone algorithm performance is described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical ground truth is established as there is no AI performing diagnostics.
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The sample size for the training set:
- Not applicable. No AI training set is mentioned.
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How the ground truth for the training set was established:
- Not applicable. No AI training and ground truth establishment are mentioned.
In summary, the provided document describes a physical medical device (a catheter) and its clearance based on bench testing and biocompatibility, not an AI or software as a medical device (SaMD) that would require the type of clinical performance validation you are inquiring about.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).