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The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.

The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is a Class II device according to 21 CFR §870.1340; product code DYB (Catheter Introducer). The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is composed of an introducer sheath and dilator. The subject device also includes additional procedural components such as a wire guide and a 21 gage needle with a 4 inch length. Some subject device configurations also include a luer locking syringe.

Here's a breakdown of the acceptance criteria and study information for the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each test conducted on the device. It generally refers to "test articles" or "devices."

• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. The testing was conducted internally by Cook Incorporated.

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

This information is not provided in the document. The tests seem to be primarily engineering and performance-based against established standards, rather than requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The testing described is objective performance testing against predefined criteria, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical instrument (catheter introducer) and not a diagnostic imaging or AI-driven decision support system, so such a study would not be relevant. The study focuses on the device's physical and functional performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a "standalone algorithm performance" study was not done. This device is a physical medical instrument, meaning there is no algorithm or AI component involved.

7. The Type of Ground Truth Used

The ground truth used for performance validation was based on established industry standards and approved study protocols. For instance:

• Biocompatibility: BS EN ISO 10993-1:2009
• Tensile Testing: BS EN ISO 11070:2014, Annex C
• Valve Leakage Testing: ISO 11070 Annex E
• Rollback and Kink Resistance: ISO 11070:2014, Annex A
• Age Testing: BS EN ISO 11070:2014
• Acute Performance: "animal model" (implying physiological outcomes measured against a standard or control)

8. The Sample Size for the Training Set

This information is not applicable as there is no mention of a "training set" for an algorithm or AI model in this device submission. The device is a physical product, not a software or AI application.

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

This information is not applicable for the same reason as point 8.

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Performer introducers and guiding sheaths are intended to introduce therapeutic devices into the vasculature.

The Performer® Introducer is manufactured using radiopaque tubing with a radiopaque band at the tip. The proximal end consists of a stopcock, connecting tube and the Y-Connector, which connects the sheath to the connecting tube and stopcock; the Y-Connector contains a hemostatic valve. The subject device is available with outside diameters ranging from 5.5 - 7 French and a length of 6 centimeters. The dilator is compatible with wire guides 0.035 inches in diameter. The supplied dilator is designed to extend beyond the tip of the sheath when the dilator is fully inserted through the hemostatic valve of the Y-Connector. The Performer® Introducer is a sterile device intended for single use only.

The provided text describes the 510(k) summary for the Cook Incorporated Performer® Introducer (K173068). It focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing against established standards rather than clinical studies involving human readers or extensive ground truth adjudication.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each test. The testing described is primarily laboratory-based physical and material testing, not human clinical trials or analysis of patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of this 510(k) summary. The "test set" refers to the manufactured device units subjected to the various physical performance tests.

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

This information is not applicable. The device is a physical medical instrument (catheter introducer), and its performance acceptance criteria are based on engineering standards (e.g., ISO, BS EN ISO) and functional requirements, not on interpretations or diagnoses by medical experts. "Ground truth" for these tests is defined by the objective measurements and adherence to the physical and material properties specified in the standards.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like "2+1" typically refer to reconciling disagreements among multiple human readers in diagnostic studies. Here, the "test set" involves objective physical and material tests with predefined acceptance criteria. The results are either "met" or "not met" based on measurements against those standards.

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 such study was done. This 510(k) summary is for a physical medical device (catheter introducer), not an AI-powered diagnostic or assistive tool.

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

No such study was done. This device is not an algorithm.

7. The type of ground truth used

The "ground truth" for the Performer® Introducer's performance is based on objective engineering and material test standards (e.g., ISO 10993-1:2009 for biocompatibility, BS EN ISO 11070-1:2014 for leakage and tensile testing, BS EN ISO 11070 for rollback and kink testing) and predetermined functional requirements (e.g., preventing flow, proper dimensions, visibility under fluoroscopy). It is not pathology, expert consensus, or outcomes data in the typical sense of a diagnostic device.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is manufactured following a design and tested against established performance standards.

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

This information is not applicable as there is no "training set."

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Performer™ Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature.

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The provided text is a 510(k) premarket notification letter from the FDA to Cook Incorporated for the Performer Introducer device. It confirms the device's substantial equivalence to legally marketed predicate devices.

However, this document does NOT contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment relevant to the device's functional performance or an AI/software component.

The document is purely a regulatory approval letter for a physical medical device (catheter introducer) and does not describe a study involving algorithms, AI, or performance metrics in the way your request specifies. The "Indications for Use" section simply states the device's intended purpose ("introduce therapeutic or diagnostic devices into the vasculature") and confirms it's for Prescription Use.

Therefore, I cannot fulfill your request based on the provided text. To answer your detailed questions, I would need a different type of document, such as a clinical study report, a performance evaluation report, or a 510(k) submission summary that includes detailed performance data for an AI or software device.

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Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic devices into the vasculature, excluding coronary and neuro vasculature.

The Flexor® Tuohy-Borst Side-Arm Introducer Ansel Modification, Flexor® Check-Flo® Introducer Ansel Modification, Flexor® Check-Flo® Introducers Ansel Modification with High-Flex Dilator and Hydrophilic Coating, Flexor® Check-Flo® Introducer Balkin Up and Over® Contralateral Design, Flexor® Up and Over® Balkin Contralateral Introducer, Flexor® Check-Flo® Introducer Raabe Modification and Flexor® Check-Flo® Performer Introducer are composed of an introducer sheath and a dilator(s). These devices are intended to be used as introducer sheaths, providing means of introducing therapeutic or diagnostic devices into the vasculature.

This document is a 510(k) Premarket Notification from the FDA regarding several Cook Inc. medical devices, specifically various configurations of their "Flexor" Introducers and Guiding Sheaths. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and performance testing.

The document does NOT describe the acceptance criteria or a study related to a device that uses AI or sophisticated algorithms or image processing where ground truth, number of experts, reader studies, or training/test sets would be relevant.

Instead, the listed "Test Data" refers to standard medical device performance testing for physical and biological characteristics, such as:

• Biocompatibility testing
• Coating integrity testing
• Dilator and introducer sheath tensile testing
• Dilator and introducer sheath liquid leakage
• Dilator and introducer sheath mechanical abrasion
• Dimensional verification
• Introducer sheath lubricity
• Thromboresistance testing
• Torque strength
• Acute Performance Testing

These tests confirm the physical and material properties of the catheter introducers meet predetermined acceptance criteria, which are typically defined by engineering specifications and relevant ISO standards (e.g., ISO 10993-1:2009 for biocompatibility, BS EN ISO 11070:1999 for introducer sheaths).

Therefore, it is not possible to extract the requested information (AI/algorithm-related acceptance criteria, test set, ground truth, expert opinions, MRMC studies, etc.) from this document. The document concerns a traditional Class II medical device, not one involving AI or diagnostic imaging interpretation.

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