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The Synchro SELECT Guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Device Description

Like the primary Predicate device, the Synchro SELECT Guidewire is a single-use product with a shapeable tip available in straight and pre-shaped configurations, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature.

The Synchro SELECT Guidewire comes in three stiffness profiles: Soft, Standard, and Support.

AI/ML Overview

The provided text describes the regulatory submission for a medical device (Synchro SELECT Guidewire) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing the kind of detailed performance study data against acceptance criteria that would typically be seen for a novel AI/ML-based device.

Therefore, the information required to answer your specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/ML device (e.g., sample size, expert ground truth, MRMC study, standalone performance, training set details) is not present in the provided document.

This document pertains to a physical medical device (guidewire) and its bench testing to establish equivalency to existing devices. The "acceptance criteria" here refer to standard engineering and material performance specifications for a guidewire, not performance metrics of an AI algorithm.

However, I can extract the acceptance criteria and performance data for the physical device based on the provided "Testing Summary" table (Table 2).

Acceptance Criteria and Reported Device Performance (Physical Device)

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

Since this is a physical medical device, the "acceptance criteria" are implied by the test methods and the "Conclusions" represent the reported performance as meeting those criteria.

Test	Acceptance Criteria (Implied by Test Method Summary)	Reported Device Performance (Conclusions)
Coating Lubricity	Hydrophilic coating lubricity assessed after 15 pull cycles through silicone pads.	All Synchro SELECT Guidewires met the specified coating lubricity requirements.
Coating Durability	Coating durability assessed after repeated pull cycles through silicone pads (comparing degradation between Cycle 1-2 and Cycles 31-45).	All Synchro SELECT Guidewires met the specified coating durability requirements.
Torque Response	Evaluate steerability and torque response compared to the predicate device through a tortuous simulated use model.	All Synchro SELECT Guidewires demonstrated acceptable torque response. The torque response of the subject device was comparable to that of the predicate device.
Tip Shape-ability (Visual)	Shape and un-shape the guidewire for a total of five times, then visually inspect the distal tip for any fractures at 40x magnifications.	All Synchro SELECT Guidewires met the specified tip shape-ability requirements.
Tip Shape-ability (Rating)	Shape the tip of the guidewire to 90 degrees and record the tip shaping rating.	All Synchro SELECT Guidewires demonstrated acceptable tip shape-ability. The tip shape-ability of the subject device was comparable to that of the predicate device.
Tip Flexibility	Measure the force required to deflect the guidewire to a specified number of degrees at 20mm.	All Synchro SELECT Guidewires met the specified tip flexibility requirements.
Tensile Strength	Measure the force required to break the guidewire tip.	All Synchro SELECT Guidewires met the specified tensile strength requirements.
Torsional Strength	Record the number of times the proximal end of the wire can be rotated until it exceeds its maximum rotations and fails.	All Synchro SELECT Guidewires met the specified torsional strength requirements.
Flexure	Testing completed per ISO 11070:2014/A1: 2018, Annex G.	All Synchro SELECT Guidewires met the specified flexure requirements.
Fracture	Testing completed per ISO 11070:2014/A1: 2018, Annex F.	All Synchro SELECT Guidewires met the specified fracture requirements.
Tip Integrity (Manipulation)	Shape, straighten, and re-shape the guidewire in the opposite direction for a total of five times. Inspect at 40X for any fractures or breaks.	All Synchro SELECT Guidewires met the specified tip integrity requirements.
Tip Integrity (Simulated Use)	Inspect the guidewire for any damage after tracking through a tortuous simulated use model.	All Synchro SELECT Guidewires demonstrated acceptable tip integrity after being tracked through a tortuous simulated use model.
Particulate Characterization	Count particulates of various size ranges after tracking through a tortuous simulated use model.	Particulate counts were reported and considered acceptable.
Hydrophilic Coating Integrity	Visually inspect and compare hydrophilic coating before and after tracking through a tortuous simulated use model. Additionally, visually inspect device coating after staining the devices.	All Synchro SELECT Guidewires met the specified hydrophilic coating integrity requirements.
Tip-shape Retention	Measure the tip shape retention after tracking the guidewire through a tortuous simulated use model.	All Synchro SELECT Guidewires demonstrated acceptable tip-shape retention. The tip-shape retention of the subject device was comparable to that of the predicate device.
Tip Prolapse	Record the force required for the wire to buckle.	All Synchro SELECT Guidewires met the specified tip prolapse requirements.
Radiopacity	Subject and predicate guidewires evaluated under fluoroscopy.	All Synchro SELECT Guidewires demonstrated acceptable radiopacity. The radiopacity of the subject device was comparable to that of the predicate device.

Regarding the specific questions tailored for AI/ML devices:

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

Not applicable / Not provided. The document describes "bench testing" of physical prototypes, not data-driven AI/ML model testing. There is no mention of "data provenance" in the context of patient data for model evaluation.

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 / Not provided. Ground truth, in the AI/ML sense, is not relevant for this physical device testing. The "ground truth" for these tests would be the established engineering specifications and measurement methodologies.

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

Not applicable / Not provided. This concept is for clinical or human reader studies, not bench testing of a 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

No. The document explicitly states: "No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology." Therefore, no MRMC study was performed.

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

Not applicable. This is a physical guidewire, not an algorithm.

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

Not applicable / Not provided. The ground truth for this device is based on engineering specifications, physical measurements, and comparison to predicate devices, as well as adherence to relevant ISO standards.

8. The sample size for the training set

Not applicable / Not provided. There is no "training set" as this is not an AI/ML device. The testing described is for physical device verification.

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

Not applicable / Not provided. Consistent with point 8, there is no training set for this type of device.

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