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The Cook Airway Exchange Catheter is intended for endotracheal tube exchange in adult and pediatric patients.

The 8 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 3 mm or larger.

When used for high-pressure oxygenation with a Luer Lock connector, the 8 French catheter is recommended for patients older than 1 month of age.

The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger.

When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age.

The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger.

When used for high-pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age.

The 19 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 7 mm or larger.

When used for high-pressure oxygenation with a Luer Lock connector, the 19 French catheter is recommended for patients older than 12 years of age.

The Cook Airway Exchange Catheter - Extra-Firm with Soft Tip is intended for endotracheal tube exchange in adult and pediatric patients.

The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger.

When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age.

The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger.

When used for high-pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age.

The Arndt Airway Exchange Catheter Set is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients.

The product may be used for emergency, urgent, and elective airway management.

The 14 French catheter is recommended for placement of an endotracheal tube or a supraglottic airway device with an inner diameter of 5 mm or larger.

When used for high-pressure oxygenation with a Luer lock connector, the 14 French catheter is recommended for patients older than 12 years of age.

The Aintree Intubation Catheter is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients.

The 19 French catheter is recommended for use with a supraglottic airway device and placement of a single-lumen endotracheal tube with an inner diameter of 7 mm or larger.

When used for high-pressure oxygenation with a Luer lock connector, the 19 French catheter is recommended for patients older than 12 years of age.

The Respiratory Management Sets are a family of airway management products, designed for establishing, re-establishing, or maintaining an airway. The catheters may be manufactured from polyurethane or polyethylene. They are single lumen catheters and are designed with a blunt or tapered distal tip. Incremental markings on the catheter shafts facilitate the accurate placement of the catheters into the airway. The subject device catheters have sideports at the distal end and the subject devices are provided with two Rapi-Fit adapters for ventilation when oxygen requirement is high and the supraglottic airway device or endotracheal tube is not in the trachea of the patients.

The Aintree Intubation Catheter is comprised of an intubation catheter, two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector), and a double swivel connector. The intubation catheter is made of polyurethane and is 19 Fr in diameter and 56 cm long. The distal end of the intubation catheter is open and designed with a straight and tapered tip, with two sideports aligned opposite to each other.

The Arndt Airway Exchange Catheter Set is comprised of an exchange catheter, a wire guide, two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector), and a double swivel connector. The catheter is made of polyurethane and is 14 Fr in diameter and 70 cm long. The distal end of the exchange catheter is open and designed with a straight and tapered tip, with six sideports spiraled along the distal tip.

The Cook Airway Exchange Catheter is comprised of an exchange catheter and two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector). The 8, 11, and 14 Fr catheters are made of polyurethane, while the 19 Fr catheter is made of polyethylene. The 8 Fr catheter is 45 cm long, while the 11, 14, and 19 Fr catheters are 83 cm long. The distal ends of the exchange catheters are open and designed with a straight and tapered tip. The 8 Fr, 14 Fr, and 19 Fr catheters have two sideports aligned opposite to each other, while the 11 Fr catheter has six sideports spiraled along the distal end.

The Cook Airway Exchange Catheter – Extra-Firm with Soft Tip are comprised of an exchange catheter and two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector). The exchange catheter is made of polyurethane intermittent extrusion tubing, with a stiff shaft and a softer distal 7 cm of the catheter is made of a softer and more flexible polyurethane). The catheter is available in diameters of 11 or 14 Fr, and a length or 100 cm. The distal ends of the exchange catheters are open and designed with a straight and blunt tip. The 11 Fr catheter has six sideports spiraled along the distal end, while the 14 Fr catheter has two sideports aligned opposite to each other.

This document is a 510(k) premarket notification for several airway management devices from Cook Incorporated. It outlines the devices, their intended use, comparison to a predicate device, and performance testing conducted.

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several performance tests and states that "The acceptance criterion was met" for each. Specific quantitative acceptance criteria or detailed performance results are generally summarized as "met," rather than providing precise numerical values.

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

The document does not specify the sample sizes used for each test. The data provenance is internal testing conducted by Cook Incorporated as part of their 510(k) submission. No information is provided regarding country of origin or whether the data is retrospective or prospective.

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

This document describes performance testing for medical devices (catheters, wire guides, adapters). For these types of physical/mechanical tests, "ground truth" is typically established by engineering specifications, accepted industry standards (e.g., ISO, BS EN ISO), and established testing methodologies, rather than expert clinical consensus or pathology. Therefore, there is no mention of human experts establishing ground truth for the technical performance tests described.

4. Adjudication Method for the Test Set

Not applicable. As described above, the acceptance is based on meeting predefined technical specifications and standards, not on human adjudication of subjective data.

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

Not applicable. This submission is for physical medical devices (catheters and their accessories), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or reported.

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

Not applicable. This is for physical medical devices, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests described is based on engineering specifications and established international standards (e.g., BS EN ISO 10555-1, ISO 5361:2012, BS EN ISO 11070, ISO 594-2, ISO 5356:2015, ISO 10993-1). For biocompatibility, it's based on adherence to ISO standards and FDA guidance.

8. The Sample Size for the Training Set

Not applicable. This is for physical medical devices, which do not have a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set mentioned or relevant for these devices.

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The Trachlight is designed to facilitate the placement of endotracheal tubes of various sizes and lengths for both orotracheal and nasotracheal intubations.

The Trachlight includes a wand with an incandescent light bulb at its tip that is placed inside the endotracheal tube prior to intubation, with the light bulb positioned at the end of the endotracheal tube. Light from the light bulb helps provide a guide for the clinician during the intubation process, and light emanating from the light bulb can be seen through the patient's tissue when the end of the endotracheal tube is properly positioned in the patient's trachea. The Trachlight consists of a reusable handle that contains the batteries and electronic circuits to apply power to the light bulb; a sterile, flexible wand that contains the light bulb at the tip; and a stylet that slides into the wand and acts as a stiffening member when needed.

This document is a 510(k) premarket notification for the Laerdal Medical Corporation's Trachlight Stylet & Trachlight Wand. It is dated January 31, 1996, and responds to a request for additional information from the FDA.

Based on the provided text, there is no direct mention of specific clinical acceptance criteria or a study designed to prove the device meets such criteria in terms of clinical performance (e.g., successful intubation rates, time to intubation, complication rates). The document focuses on regulatory classification, substantial equivalence to predicate devices, and safety aspects related to material biocompatibility and temperature limits.

It primarily addresses two points:

1. Summary Section of Submission: This covers the classification name, common name, proprietary name, establishment registration, device classification (Class II), performance standards (none specifically applicable per Section 514 of the Act), labeling, and substantial equivalence to other marketed devices. It describes the Trachlight's function as a lighted stylet to facilitate endotracheal tube placement.
2. Mucosal Contact Standard: This section details that materials that could contact the patient are qualified biocompatible (USP class V or higher) and that the tip temperature does not exceed UL Standard 544 requirements of 50°C.

Therefore, many of the requested details about acceptance criteria and study design are not present in this document because it is focused on regulatory submission information rather than a clinical performance study.

Here's an attempt to answer the questions based only on the provided text:

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

2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set or study with a sample size for evaluating clinical performance. The safety criteria (biocompatibility, temperature) are likely based on laboratory testing and material specifications, not a patient-based test set in the context of clinical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical performance test set or ground truth establishment by experts is described in this regulatory submission.

4. Adjudication method for the test set
Not applicable, as no clinical performance test set is described.

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
Not applicable. This device is a lighted stylet, not an AI-assisted diagnostic tool or a device that involves "human readers."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety criteria:

• Biocompatibility: Ground truth is established by chemical and biological testing results against USP Class V standards.
• Temperature: Ground truth is established by direct temperature measurements against the UL Standard 544.
  For clinical performance, no specific ground truth or study is described, as the device's efficacy is asserted through substantial equivalence to existing devices.

8. The sample size for the training set
Not applicable. This document does not describe the development or validation of an algorithm requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

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