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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.

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.

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 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

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

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The CXIM TriForce Peripheral Crossing Set 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.

The CXI™ TriForce is designed to facilitate wire guide exchange, infusion, and wire guide support. Each set contains the following sterile components:

• Outer 5.0 French Flexor® introducer .
• Inner 4.0 French CXI™ Support Catheter .
• Peel-Away® sheath .
  The outer Flexor® introducer is manufactured with a stainless steel coil reinforced nylon construction which provides both flexibility and support to the sheath during use. The outer Flexor introducer is used to support the inner CXI™ Support Catheter during a procedure. The outer Flexor introducers are available in length measurements of 55 or 90 centimeters and can be manufactured with an angled or a straight tip. The inner CXI™ Support Catheter is manufactured with 4.0 French braided flexible kink resistant shaft materials with hydrophilic coating. The flexible shaft material is a laminated material consisting of a nylon layer, stainless steel braiding and an inner polyimide, polyurethane layer, and an innermost polytetrafluoroethylene layer. The inner CXI™ Support Catheters allow acceptance of a 0.035 inch diameter (0.89 millimeters) wire guide. The inner CXI™ Support Catheter will support a wire guide while performing percutaneous peripheral intervention. The CXI™ Support Catheters are available in length measurements of 65 or 100 centimeters and can be manufactured with an angled or a straight tip.
  The tetrafluoroethylene Peel-Away® sheath is included in the set for assistance when inserting the inner CXI™ Support Catheter into the outer Flexor® introducer.

This document describes the acceptance criteria and study proving the device meets those criteria for the CXI™ TriForce Peripheral Crossing Set.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the exact sample sizes for each test conducted on the CXI™ TriForce Peripheral Crossing Set. The studies are described as "applicable testing to assure reliable design and performance" and "appropriate engineering tests." The data provenance is not specified, but the tests were performed by Cook Incorporated, a US-based company. These are likely prospective engineering and laboratory tests, not clinical studies on human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable. The tests performed are engineering and laboratory tests (e.g., tensile strength, burst pressure) on the device itself, not clinical studies requiring expert interpretation of patient data or establishment of ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for the direct physical and chemical property testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. The studies conducted are focused on the device's physical and biological performance against established standards, not on human reader performance, with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device itself was subjected to various engineering and biocompatibility tests to ensure it met predetermined acceptance criteria. These tests were "algorithm only" in the context of device performance, as they measured the intrinsic characteristics of the product.

7. Type of Ground Truth Used

The "ground truth" for these tests consisted of predetermined physical and chemical specifications and standards as outlined in international and national standards (BS EN ISO 11070, ISO 10555-1, ISO 10993-1). The device's performance was measured against these established parameters. For example, the ground truth for tensile strength testing would be a specified maximum force the device must withstand without failure.

8. Sample Size for the Training Set

This information is not applicable. The listed studies are not AI/machine learning studies and therefore do not involve "training sets" in that context. The device performance was evaluated through direct testing against predetermined criteria.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there was no "training set." The performance criteria were established based on recognized engineering standards and regulatory requirements.

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