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The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

Device Description

The Aristotle 18 Guidewire is a modification of Scientia Vascular's Aristotle 14 Guidewire. It is a 0.018" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a range of stiffness profiles: soft, standard, and support. The product is provided in one overall length of 200cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels. The guidewire is provided with an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.

AI/ML Overview

This document describes the safety and performance testing for a medical device called the "Aristotle 18 Guidewire" to demonstrate its substantial equivalence to a predicate device, the "Aristotle 14 Guidewire." This is a 510(k) premarket notification, not a clinical study of an AI/ML device, therefore many of the requested criteria are not applicable.

Here's an analysis of the provided text in relation to your request:

Key Takeaway: The provided document is a 510(k) summary for a guidewire, which is a physical medical device, not an AI/ML diagnostic or treatment device. Therefore, many of the questions related to AI/ML device performance (such as MRMC studies, training/test sets, ground truth establishment by experts, and adjudication methods) are not applicable to this submission. The "study" described herein refers to non-clinical performance and biocompatibility testing of a physical product.

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

The document provides a table summarizing functional tests and their results. The "acceptance criteria" are implied by the "Results" column, indicating that the device "met," "demonstrated acceptable," or "showed acceptable" performance according to relevant standards (ISO 11070, AAMI TIR 28:2016, ASTM D 4169:16) and internal specifications.

Test	Test Method Summary	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	In vitro blood flow loop thrombogenicity, MEM elution, toxicological risk assessment, ASTM hemolysis (direct/extract), PTT, complement activation	Equivalent to predicate device	Established that the biocompatibility profile of the subject device is equivalent to the predicate device due to identical materials and no increased thrombogenic potential from increased surface area. New testing was conducted to specifically address the increased diameter.
Sterilization	100% Ethylene Oxide (EO) to achieve SAL of at least 10^-6, evaluated per AAMI TIR 28:2016	SAL of at least 10^-6	The device was adopted into an EO sterilization processing group, and review indicates similarity between Aristotle 18 and Aristotle 14 regarding characteristics affecting sterilization.
Functional Testing	Per ISO 11070:2014 & FDA Guidance Document Coronary and Cerebrovascular Guidewire Guidance (Jan 1995)
Visual Inspection	For extraneous matter, process/surface defects, trauma-causing defects.	No defects observed	No extraneous matter, surface defects or visible droplets of coating are present on the Aristotle 18 Guidewires.
Dimensional Verification	Per engineering drawings.	Met dimensional specifications	All Aristotle 18 guidewires met dimensional specifications.
Tensile Strength	Per ISO 11070.	Met minimum force breakage	All Aristotle 18 guidewires meet minimum force breakage requirements specified in ISO 11070.
Flexing Test	Inspection for defects, damage, or flaking of coating after flexing.	No defects or damage	No defects or damage / flaking of the coating were observed after flexing.
Fracture	Inspection for fracture, loosening, or failure after wrapping around mandrel.	No fracture, loosening, or failure	No Aristotle 18 guidewires showed signs of fracture, loosening, or failure after wrapping them 8 times around a mandrel.
Torqueability	Measurement of torque response (avg input to output lag) in anatomical model.	Acceptable, comparable to predicate	All Aristotle 18 guidewires demonstrated acceptable torque responses. The torque response of the subject device was comparable to that of the predicate device.
Torque Strength	Torque turns to failure in anatomical model.	Acceptable, comparable to predicate	All Aristotle 18 guidewires demonstrated acceptable torque strength. The torque strength of the subject device was comparable to that of the predicate device.
Tip Flexibility	Measure force to deflect guidewire tips to 45 & 90 deg at 5mm, 10mm, 20mm.	Acceptable, comparable to predicate	The forces required to deflect the Aristotle 18 guidewire tips were acceptable. The flexibility of the tips of all subject devices was comparable to the tip flexibility of the predicate guidewire.
Tip Shape, Retention	Must be shapeable and retain shaped angle after simulated use.	Met requirements	All tips met shaping and shape retention requirements after simulated use.
Particulate	Particulates of various size ranges counted after simulated use in tortuous path.	Comparable to predicate	A comparable number of particulates was recovered from subject and predicate device following simulated use.
Coating Lubricity & Durability	Frictional force determined after simulated use in tortuous path.	Met specified requirements	All Aristotle 18 guidewires met specified frictional force requirements.
Coating Integrity	Uniformity/integrity visually examined on dyed samples after simulated use in tortuous path.	Acceptable coverage	All Aristotle 18 guidewires showed acceptable coating coverage after simulated use.
Simulated Use Model Testing & Product Compatibility	Anatomical model (neurovasculature) for simulated use testing.	Acceptable performance	Aristotle 18 Guidewires and predicate devices were found to perform acceptably in evaluations of: Torqueability in tortuous vasculature, Lubricity, Microcatheter Support & Tracking, Compatibility with Introducer, Compatibility with Torque Device, and Compatibility with Microcatheter.
Usability Evaluation	Physicians evaluated subject/predicate guidewires for various characteristics in human cadaver.	Acceptable performance	Subject and predicate guidewires both exhibited acceptable performance.
Radiopacity	Physicians evaluated during simulated use in human cadaver.	Acceptable radiopacity	Both subject and predicate guidewires exhibited acceptable radiopacity.
Corrosion Resistance	Per ISO 11070, after soaking in typical end-use solutions.	No signs of corrosion	There were no signs of corrosion on guidewires after soaking in typical end-use solutions.
Compatibility with Agents	Exposed to saline, contrast agents, DMSO, then examined for degradation.	No degradation, corrosion, decomp.	All Aristotle 18 guidewires showed no signs of degradation, corrosion or physical decomposition after exposure.
Packaging	Simulated transportation test per ASTM D 4169:16.	Product secured, labeling legible	Following exposure to typical storage and transportation conditions, product remained secured and labeling remained affixed and legible.

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

Sample Size: The document does not specify the exact number of guidewires tested for each functional test. It refers to "All Aristotle 18 guidewires" (e.g., for tensile strength, torqueability, flexibility), implying that the entire batch or lot tested passed. For biocompatibility, it states "new biocompatibility testing was conducted" but does not give sample sizes.
Data Provenance: The tests are non-clinical, laboratory-based functional and material tests. There is no "country of origin" for patient data as no patient data was used. These tests are prospective, meaning they were performed specifically for this 510(k) submission.

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 a physical device testing summary. "Ground truth" in the context of AI/ML diagnostic studies (where experts typically label images) is not relevant here.
However, for usability and radiopacity evaluations, "physicians" were used in a simulated use (cadaver) model. The number and qualifications of these physicians are not specified.

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

Not Applicable. This concept is for resolving discrepancies in expert labeling or diagnoses in AI/ML performance studies. It is not relevant to the functional testing of a physical guidewire.

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 specific to AI/ML software. The submission describes a physical medical device.

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

Not Applicable. This is specific to AI/ML software.

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

Ground Truth (for this type of device): The "ground truth" for a physical medical device like a guidewire is established by adherence to engineering specifications, validated test methods (e.g., ISO, ASTM standards), and risk assessments. For biocompatibility, the "ground truth" is that the materials are safe for human contact and do not induce adverse biological responses, often confirmed through standardized in vitro and in vivo tests. For functional performance, the "ground truth" is that the device performs reliably according to its design parameters and intended use.
For the usability and radiopacity assessments, the "ground truth" was physician evaluation in a simulated (cadaver) environment, where they determined "acceptable performance" and "acceptable radiopacity."

8. The sample size for the training set

Not Applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not Applicable. As above, no training set was used.

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