The CXI TriForce is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral intervention. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

Device Description

The CXI™ TriForce Peripheral Crossing Set is an introducer set, supplied with a 5.0 French Flexor introducer sheath, a 4.0 French CXI Support Catheter and a peel-away sheath. The sets are compatible with the supplied 0.035" wire guide. The sets are supplied sterile and intended for one-time use.

AI/ML Overview

The provided text is a 510(k) summary for the CXI TriForce Peripheral Crossing Set. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device. However, it does not contain the level of detail requested for a comprehensive acceptance criteria and study description as would be found for a novel AI/ML-based medical device.

Specifically, the document focuses on the mechanical and material performance of a physical medical device (a catheter and introducer set), not the performance of an AI/ML algorithm. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this type of traditional medical device submission.

The document states that:

"Acute Performance - Testing performed verified that performance parameters were acceptable for clinical use. The predetermined acceptance criterion was met."
"Check-Flo valve liquid leakage testing -- Testing verified that the Check-Flo valve will not experience excessive leakage when utilized according to the device's intended use. The predetermined acceptance criteria were met."
"Flow Rate Testing - Flow rates through the device were measured at designated injection pressures using saline and contrast."
"Biocompatibility testing... The predetermined acceptance criteria were met."

Without specific numerical values for the acceptance criteria and performance (e.g., "leakage rate < X mL/hr" or "flow rate > Y mL/sec"), and the exact methodology and sample sizes for these tests, it is impossible to construct the tables and detailed study information requested for a robust AI/ML device evaluation.

Therefore, I will explain why this document does not contain the requested information and provide a general structure of what such a response would look like if the relevant information were available.

Explanation of Missing Information and Why:

The provided document (K170931) is a 510(k) summary for a physical medical device (CXI TriForce Peripheral Crossing Set), which is a catheter and introducer set. It is not an AI/ML-driven device. The regulatory submission for such a device focuses on:

Mechanical performance: How well the device functions physically (e.g., acute performance, leakage, flow rates).
Biocompatibility: Ensuring the materials are safe for contact with the human body.
Sterility: Ensuring the device is free from microorganisms.
Material compatibility: With other fluids or devices.

Consequently, the types of "acceptance criteria" and "study data" presented are related to these physical and material characteristics, and not to diagnostic accuracy, sensitivity, specificity, reader performance, or multi-reader multi-case studies, which are pertinent to AI/ML devices.

What a complete answer for an AI/ML device would look like (if the information were available):

Based on the provided document, the device is a physical medical device (catheter and introducer set), not an AI/ML-driven device. Therefore, the detailed criteria related to AI/ML algorithm performance, such as sensitivity, specificity, inter-reader variability, human reader improvement with AI assistance, and specific data provenances for AI model training/testing, are not applicable to this submission and are not present in the provided text.

The document generally states that "predetermined acceptance criteria were met" for various physical and material tests, but it does not provide the specific numerical acceptance criteria or the reported performance values.

Below is a template of how such an answer would be structured if the device were an AI/ML product and the necessary information was available.

Acceptance Criteria and Device Performance (Hypothetical for an AI/ML Device):

(1) A table of acceptance criteria and the reported device performance

Performance Metric	Acceptance Criterion (e.g., AI/Human Combined)	Reported Device Performance (e.g., AI/Human Combined)
Primary Endpoint	(e.g., Specificity ≥ 85%)	(e.g., 87.2%)
Secondary Endpoints
Sensitivity	(e.g., Sensitivity ≥ 90%)	(e.g., 91.5%)
Accuracy	(e.g., Accuracy ≥ 88%)	(e.g., 89.0%)
AUC	(e.g., AUC ≥ 0.90)	(e.g., 0.92)
Workflow Improvement (e.g., time to diagnosis)	(e.g., Reduction of 15% in read time)	(e.g., 18% reduction)
Agreement with Ground Truth	(e.g., Kappa coefficient ≥ 0.70)	(e.g., 0.75)

Study Details (Hypothetical for an AI/ML Device):

(2) Sample size used for the test set and the data provenance

Test Set Sample Size: [e.g., 500 cases (images/studies)]
Data Provenance: [e.g., Multi-center retrospective study from hospitals in the USA, UK, and Germany. Data collected between 2018-2022.]

(3) Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: [e.g., 3-5 independent experts]
Qualifications: [e.g., Board-certified Radiologists with >10 years of experience in [specific domain, e.g., chest radiography, mammography, etc.], specializing in [specific sub-specialty if applicable].]

(4) Adjudication method for the test set

Adjudication Method: [e.g., 2+1 (two experts review independently, and if they disagree, a third senior expert adjudicates). OR Majority vote (if >3 experts). OR Consensus meeting. OR None (if a single definitive ground truth like pathology was used).]

(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

MRMC Study Done: [e.g., Yes]
Effect Size: Human readers improved [e.g., sensitivity by X%, specificity by Y%, or overall accuracy by Z%] when assisted by the AI device compared to reading without AI assistance. [e.g., Mean AUC for readers increased from 0.85 to 0.91 when using AI, a statistically significant improvement (p < 0.001).]

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

Standalone Performance Test Done: [e.g., Yes]
Standalone Metrics: [e.g., Standalone Sensitivity: 92%, Standalone Specificity: 86%, Standalone AUC: 0.90.]

(7) The type of ground truth used

Ground Truth Type: [e.g., Expert consensus (as described above), Pathology reports (biopsy-confirmed disease status), Clinical outcomes data (e.g., 1-year follow-up for disease progression), or a combination thereof.]

(8) The sample size for the training set

Training Set Sample Size: [e.g., 10,000 cases (images/studies).]

(9) How the ground truth for the training set was established

Training Ground Truth Establishment: [e.g., Ground truth for the training set was primarily established by a single expert review for initial labeling, followed by automated quality checks and a subset validated by consensus of two experts. Or, leveraged existing clinical reports and verified by a smaller expert review panel.]

Conclusion regarding the provided document:

The provided K170931 document is a traditional 510(k) summary for a physical medical device. It successfully demonstrates the device's adherence to physical performance and safety criteria (acute performance, leakage, flow rates, biocompatibility) through testing. However, it does not contain the type of data or studies (e.g., diagnostic accuracy, reader studies, AI performance metrics) that would be relevant for an AI/ML-driven medical device, and thus cannot fulfill the specific requirements of the prompt related to such technologies.

Summary

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November 13, 2017

Cook Incorporated Ms. Sarah Reeves Regulatory Affairs Manager 750 Daniels Wav, P.O. Box 489 Bloomington, Indiana 47402

Re: K170931

Trade/Device Name: CXI TriForce Peripheral Crossing Set Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: October 24, 2017 Received: October 25, 2017

Dear Ms. Reeves:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170931

Device Name

CXI TriForce Peripheral Crossing Set

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background. The red background is shaped like a trapezoid.

510(k) SUMMARY

Submitted By:

Sarah Reeves, RAC Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (812) 335-3575 x175024 Fax: (812) 332-0281 Date Prepared: 31 October 2017

Device:

Trade Name: Common Name: Classification: Product Code (Regulation): CXI™ TriForce Peripheral Crossing Set Continuous flush catheter Class II DYB (21 CFR §870.1340)

Indications for Use:

The CXI™ TriForce is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral intervention. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

Predicate Device:

The device, subject of this submission, is substantially equivalent to the predicate device of identical name, the CXI™ TriForce Peripheral Crossing Set, cleared under 510(k) number K111263. Additionally, the Flexor Radial Hydrophilic Introducer Access Set (K152044) and the Flexor Check-Flo Introducer, Ansel Modification, Flexor Check-Flo Introducer, Balkin Up and Over Contralateral Design, Flexor Check-Flo Introducer, Raabe Modification and Flexor Check-Flo Performer Introducer (K142829) are considered reference devices for this submission.

COOK INCORPORATED 750 DANIELS WAY, P.O. BOX . LOOMINGTON, IN 47402-0489 812.339.2235 TOLLEREE: 800.45 WWW.COOKMEDICAL.CC

K170931 Page 1 of 3

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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The red background is shaped like a rectangle with a notch cut out of the lower left corner.

SO DANIELS WAY DO F

Comparison to Predicate Device:

It has been demonstrated that the CXI™ TriForce Peripheral Crossing Set is comparable to the predicate device. The CXI™ TriForce Peripheral Crossing Set is identical in terms of intended use, principles of operation, basic technological characteristics, and materials of construction, with the exception of the modification to labeling and check-flo valve, to the predicate device. The check-flo valve material and design has been modified to provide more consistent hemostasis. The labeling has been updated to provide the user more accurate information for clinical use. The testing performed supports a determination of substantial equivalence to the predicate device.

Device Description:

Test Data:

The following tests were performed to demonstrate that the CXI™ TriForce Peripheral Crossing Set met applicable design and performance requirements and support a determination of substantial equivalence.

. Acute Performance - Testing performed verified that performance parameters were acceptable for clinical use. The predetermined acceptance criterion was met.
. Check-Flo valve liquid leakage testing -- Testing verified that the Check-Flo valve will not experience excessive leakage when utilized according to the device's intended use. The predetermined acceptance criteria were met.
. Flow Rate Testing - Flow rates through the device were measured at designated injection pressures using saline and contrast.

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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, and the word "MEDICAL" is in a smaller, white, sans-serif font below the word "COOK".

The following tests were leveraged to support a determination of substantial equivalence.

. Biocompatibility testing – cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity and hemocompatibility, including partial thromboplastin time, SC5b-9 and C3a complement activation assay, testing have been completed. The predetermined acceptance criteria were met.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).