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The CrossTorqTM 14 Guidewire is intended for general vascular use within the coronary and peripheral vasculatures to introduce and position catheters and other interventional devices. The CrossTorqTM 14 Guidewire is not intended for use in the neurovasculature.

Device Description

Scientia Cardio Access's CrossTorg™ 14 Guidewire is a 0.014" 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 with the 4 different tip loads, or tip stiffnesses: 1 gram. 10 gram, and 15 gram. These tip stiffnesses are referred to as Soft, Standard, Support, and Extra Support. respectively. The product is offered in lengths of 200cm and 300cm.

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 a shaping mandrel (to shape the flexible tip of the guidewire), 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 shaping mandrel, 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

The provided text describes a 510(k) premarket notification for the "CrossTorq 14 Guidewire". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or clinical superiority. Therefore, the acceptance criteria and study described are geared towards demonstrating this equivalence through non-clinical performance and functional testing.

Here's a breakdown based on your requested information:

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

The document lists various tests with associated "Results." For substantial equivalence, the "acceptance criteria" are implicitly that the new device performs "as well as the predicate devices and/or meets requirements of relevant standards" or that any differences "do not raise different questions of safety and effectiveness."

Test Category	Specific Test	Acceptance Criteria (Implicit from context)	Reported Device Performance/Results
Biocompatibility	General Biocompatibility	Identical materials and processing to reference devices (Aristotle 18 Guidewire K183608, Aristotle 14 Guidewire K173235) such that dimensional change does not alter chemical/physical properties or involve new biological interactions. Low and acceptable biological and toxicological risk.	The materials and processing are identical to the reference Aristotle 18 Guidewire (K183608) in formulation, processing, sterilization, and geometry, with only a smaller outer diameter. This dimensional change does not alter chemical/physical properties, allowing results from the Aristotle 18 Guidewire to be applied. No additional biological evaluations were deemed necessary as the design presents a low and acceptable biological risk.
	Radiopacity	Acceptable radiopacity for physician visualization in human cadaver.	Guidewires exhibited acceptable radiopacity.
	Corrosion Resistance	No signs of corrosion after soaking in typical end-use solutions (per ISO 11070).	There were no signs of corrosion on guidewires after soaking in typical end-use solutions.
	Chemical Compatibility	No signs of degradation, corrosion, or physical decomposition after exposure to saline and contrast agent/saline solutions.	All guidewires showed no signs of degradation, corrosion or physical decomposition after exposure.
	Latex	No detectable traces of latex proteins (per ASTM D6499-07).	No detectable traces of latex were found.
	Accessories Testing	Acceptance criteria of all tests (biocompatibility, visual inspection, corrosion resistance, tensile testing, luer taper dimensions) for torque device and shaping mandrel were met.	Acceptance criteria of all tests were met.
	Package Integrity	All sterile barrier pouches maintained integrity and labeling remained affixed and legible after simulated transportation (per ASTM D 4169:16). Seal strength (ASTM F 88-15) and leak tests (ASTM F 2096-11) criteria met.	Following exposure to typical storage and transportation conditions, all sterile barrier pouches maintained their integrity and labeling remained affixed and legible.
	Sterilization Validation	SAL of at least 10^-6, results justified adoption into EO sterilization processing group. PCDs more difficult to sterilize than devices. Bioburden Enumeration and Extraction Efficiency, and Bacteriostasis/Fungistasis test results demonstrated.	Results justified adoption into the EO sterilization processing group: Comparative and Bioburden Resistance study results demonstrated that PCDs are more difficult to sterilize than devices; Bioburden Enumeration and Extraction Efficiency tests were used to enumerate the CFUs present on devices; and Bacteriostasis/Fungistasis test results demonstrated that the product does not inhibit the growth of organisms.
	Sterilization Validation: EO and ECH Residuals	Residual traces of EO and ECH well below limits specified in ISO 10993-7.	The residual traces of EO and ECH remaining in the CrossTorq 14 Guidewire after exposure to the EO sterilization process are well below the limits specified in ISO 10993-7.
	Sterilization Validation: Bacterial Endotoxin Levels	< 2.15 EU/device (per ANSI/AAMI ST72:2011/(R)2016, USP <161>, and USP <85>).	< 2.15 EU/device.
Functional Testing	Visual Inspection	No extraneous matter, process and surface defects, or defects that may cause trauma to vessels (per ISO 11070).	No extraneous matter, surface defects or visible droplets of coating were present on the CrossTorq 14 Guidewires.
	Dimensional Verification	All guidewires met dimensional specifications (per engineering drawings).	All guidewires met dimensional specifications.
	Flexing Test	No defects or damage/flaking of coating after flexing (per ISO 11070).	No defects or damage / flaking of the coating were observed after flexing.
	Tensile Strength	All guidewires met minimum clinically relevant force breakage requirements (per ISO 11070).	All guidewires met minimum clinically relevant force breakage requirements when tested according to ISO 11070.
	Tip Shape, Retention	All tips were shapeable and retained shaped angle after simulated use.	All tips met shaping and shape retention requirements after simulated use.
	Torqueability	Acceptable torque responses, comparable to predicate device.	All guidewires demonstrated acceptable torque responses. The torque response of the subject device was comparable to that of the predicate device.
	Torque Strength	Acceptable torque strength, comparable to predicate device.	All guidewires demonstrated acceptable torque strength. The torque strength of the subject device was comparable to that of the predicate device.
	Tip Flexibility	Forces required to deflect softer CrossTorq 14 tips comparable to Kinetix; stiffer tips comparable to Boston Scientific Hornet 14.	The forces required to deflect the guidewire tips of the softer CrossTorq 14 tip profiles were comparable to the forces required to deflect the Kinetix, while the forces required to deflect the tips of the stiffer CrossTorq 14 tip profiles were comparable to the forces required for the Boston Scientific Hornet 14 guidewire tips.
	Fracture	No signs of fracture, loosening, or failure after wrapping around mandrel (per ISO 11070).	No guidewires showed signs of fracture, loosening, or failure after wrapping them 8 times around a mandrel.
	Coating Lubricity and Durability	All guidewires met specified frictional force requirements after simulated use.	All guidewires met specified frictional force requirements.
	Coating Integrity	Acceptable coating coverage after simulated use.	All samples showed acceptable coating coverage after simulated use.
	Particulates	All guidewires met specified number/size recovered particulate requirements after simulated use.	All guidewires met specified number/size recovered particulate requirements.
	Simulated Use Model Testing and Product Compatibility	Acceptably performed in evaluations of: Torqueability in tortuous vasculature, Lubricity, Microcatheter and Balloon Catheter Support & Tracking, Compatibility with Introducer, Compatibility with Torque Device, and Compatibility with Microcatheter and Balloon Catheter.	Guidewires and predicate devices were found to perform acceptably in evaluations of: Torqueability in tortuous vasculature, Lubricity, Microcatheter and Balloon Catheter Support & Tracking, Compatibility with Introducer, Compatibility with Torque Device, and Compatibility with Microcatheter and Balloon Catheter.
	Column Buckling	Forces required to buckle softer CrossTorq 14 tips comparable to Kinetix; stiffer tips comparable to Boston Scientific Hornet 14.	The forces required to buckle the guidewire tips of the softer CrossTorq 14 tip profiles were comparable to the forces required to deflect the Kinetix, while the forces required to buckle the tips of the stiffer CrossTorq 14 tip profiles were comparable to the forces required for the Boston Scientific Hornet 14 guidewire tips.
	MRI Compatibility	Device must be labeled "MRI Unsafe" as it contains metallic materials and should not be exposed to MRI procedures.	No testing performed. CrossTorq 14 Guidewires are labeled "MRI Unsafe."
	Shelf Life	All device performance acceptance criteria met after exposure to accelerated aging conditions simulating real-time storage for 13 months.	After exposure to accelerated aging conditions simulating real-time storage under ambient conditions for 13 months, all device performance acceptance criteria were met, justifying labeling the devices with a 1-year shelf life.

2. Sample sized 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 explicitly state the numerical sample size (n-value) for each specific test, nor does it detail multiple test sets. The functional and biocompatibility tests generally refer to "Guidewires" or "All guidewires" or "All samples" in the results, implying that a sufficient number were tested to satisfy the testing standards (e.g., ISO 11070). For "Radiopacity," it mentions "Guidewires evaluated by physicians in human cadaver" without specifying the number of guidewires or cadavers.
Data Provenance: The document states that "Results for following tests, performed on the reference Aristotle 14 Guidewires and reference Aristotle 18 Guidewires, were included in Scientia Vascular LLC's premarket notifications K173235 and K183608..." This indicates some data was leveraged from previous submissions for reference devices. For the CrossTorq 14 Guidewire, the tests performed appear to be prospective (i.e., new tests done for this submission), although the location where they were performed is not specified. There is no information about country of origin.

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)

The only mention of "experts" is for the "Radiopacity" test, stating "Guidewires evaluated by physicians in human cadaver." No specific number or qualifications of these physicians are provided.
For other functional tests (e.g., simulated use, torqueability), the methods describe objective measurements or observations ("acceptable torque responses," "no defects or damage"), implying expert judgment primarily in setting the testing parameters and interpreting compliance with established standards, but not necessarily in adjudicating a "ground truth" for classification purposes.

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

No formal adjudication method (like 2+1 or 3+1 consensus) is described. The tests are primarily objective measurements or evaluations against defined standards (ISO 11070, ASTM standards). The "Radiopacity" test mentions physician evaluation, but the decision process is not detailed as an adjudication.

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 device (a guidewire) is a physical medical device, not an AI-assisted diagnostic tool or software. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

This question is not applicable. The CrossTorq 14 Guidewire is a physical interventional medical device, not an algorithm or AI system.

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

For this type of device and submission (510(k) for a guidewire), "ground truth" is established through adherence to recognized performance standards (e.g., ISO 11070), engineering specifications, and comparative non-clinical testing against predicate devices. It relies on objective physical measurements and empirical demonstrations of performance characteristics like tensile strength, torqueability, flexibility, and biocompatibility, rather than clinical outcomes or diagnostic classifications requiring expert consensus.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML model that requires a "training set." The development of the guidewire involves design, materials selection, and manufacturing processes, supported by engineering principles and testing.

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

This question is not applicable, as there is no "training set" for this physical device.

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