(45 days)
The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
The SelectFlex Neurovascular Access System Family consists of sterile, single-use intravascular catheters used to facilitate access to target vasculature during interventional procedures. The system is composed of a SelectFlex Neurovascular Access Catheter, a 3cc Mode Control Syringe, a 7Fr Peel Away Introducer, Luer Activated Valve and a Dilator (only for versions with a Long Hydrophilic coating to ease dermal entry). The SelectFlex Neurovascular Access Catheter comes in usable lengths of 95, 105 or 115cm. The SelectFlex Neurovascular Access Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex Neurovascular Access Catheter comes in two options of a short hydrophilic coating length of 11.5cm or a long hydrophilic coating length of 30cm.
The provided FDA 510(k) summary for the SelectFlex Neurovascular Access System Family describes non-clinical performance data (bench testing) to demonstrate substantial equivalence to a predicate device, rather than a study involving human subjects or AI performance metrics. Therefore, many of the requested elements pertaining to AI studies, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document.
Here's the information that can be extracted and a clear indication where the requested information is not available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Visual Surface Requirements (catheter and dilator) | All samples meet pre-determined acceptance criteria | PASS (All samples met the pre-determined acceptance criteria) |
| Dimensional Verification (catheter and dilator) | All samples meet pre-determined acceptance criteria | PASS (All samples met the pre-determined acceptance criteria) |
| Simulated Use/Usability | All samples meet pre-determined acceptance criteria | PASS (All samples met the pre-determined acceptance criteria) |
| Flexion Fatigue | All samples meet pre-determined acceptance criteria | PASS (All samples met the pre-determined acceptance criteria) |
| Inflation Fatigue | All samples meet pre-determined acceptance criteria | PASS (All samples met the pre-determined acceptance criteria) |
| Burst Volume | All samples meet pre-determined acceptance criteria | PASS (All samples met the pre-determined acceptance criteria) |
| ISO 80369-7: Small Bore Connectors for Hypodermic Applications | All samples meet pre-determined acceptance criteria | PASS (All samples met the pre-determined acceptance criteria) |
| Particulate Count | All samples meet pre-determined acceptance criteria | PASS (All samples met the pre-determined acceptance criteria) |
| Peak Tensile Testing (catheter and dilator) | All samples meet pre-determined acceptance criteria | PASS (All samples met the pre-determined acceptance criteria) |
Note: The document states "All samples met the pre-determined acceptance criteria" for each test, implying that the acceptance criteria were defined prior to testing, but the specific quantitative or qualitative criteria for each test (e.g., maximum allowable particulate count, specific tensile strength values, specific pass/fail conditions for visual inspection) are not explicitly detailed in this summary.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for each bench test beyond "All samples." It states "Simulated use testing includes a usability assessment with multiple physicians" but does not give a number for the physicians or the number of simulated cases.
Data Provenance: The data is from non-clinical bench testing and simulated use conditions, not from human clinical data or retrospective/prospective studies on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI performance study requiring ground truth established by experts. For the "Simulated Use/Usability" test, it mentions "multiple physicians," but their specific number or qualifications are not provided as they are assessing usability, not establishing ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI performance study requiring adjudication of expert readings.
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
No MRMC comparative effectiveness study was done. This document describes the substantial equivalence of a physical medical device (catheter system) based on bench testing, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document does not describe an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical bench tests, "ground truth" would be objective measurements against engineering specifications and industry standards (e.g., ISO 10555-1: 2013, ISO 80369-7) rather than clinical ground truth types like pathology or expert consensus.
8. The sample size for the training set
Not applicable. This document does not describe an AI system that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This document does not describe an AI system.
§ 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).