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The Frova Intubating Introducer is indicated to facilitate endotracheal intubation in patients where visualization of the glottis is inadequate e.g., as in grade II and III Cormack-Lehane views. This indication applies for introduction of a single lumen endotracheal tube with an inner diameter of 6 mm or larger.

The Frova Intubating Introducer is also designed for transient oxygenation or jet ventilation in combination with 14 Fr compatible Rapi-Fit Adapters (15 mm and female Luer lock connector). The Rapi-Fit Adapters should only be used when oxygen requirements are high.

The Frova Intubating Introducer is a 14 French, 70 cm long radiopaque introducer with centimeter markings and a blunt, curved tip that can be passed into the trachea. The introducer has a through lumen design with two distal sideports to ensure adequate airflow. The Frova Intubating Introducer can be supplied with a stiffening stylet and two Rapi-Fit® Adapters for connection to an oxygen source.

The Frova Intubating Introducer is designed to facilitate airway intubation and allows for transient oxygenation and/or jet ventilation during the initial intubation.

The Rapi-Fit Adapter with a 15 mm connector is intended for use with a 14 Fr Frova Intubating Introducer for connection to an oxygen source to facilitate transient oxygenation during intubation.

The Rapi-Fit Adapter with a female Luer lock connector is intended for use with a 14 Fr Frova Intubating Introducer for connection to an oxygen source to facilitate transient oxygenation or jet ventilation during intubation.

The stiffening stylet is intended to add rigidity to the proximal and middle sections of the introducer, while the distal portion remains flexible.

The different configurations of the Frova Intubating Introducer are supplied sterile and are for single use only.

Based on the provided FDA 510(k) Clearance Letter for the Frova Intubating Introducer, it is explicitly stated that no performance testing was warranted in support of this 510(k) premarket notification. Therefore, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The reason provided is: "No changes to the design, manufacturing, sterilization, or principles of operation have been introduced with the subject device. Therefore, no performance testing was warranted in support of this 510(k) premarket notification." This indicates that the clearance relies on its substantial equivalence to a previously cleared predicate device (K161813), and the proposed changes are limited to labeling harmonization.

Consequently, I cannot fill out the requested information regarding acceptance criteria and performance studies from this document. If this were a new device or a device with significant changes, such information would be crucial for its clearance.

Here's a breakdown of why each section cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document explicitly states no performance testing was warranted.
2. Sample sizes used for the test set and the data provenance: Not applicable, as no performance testing was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance testing was conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no performance testing was conducted.
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 physical medical introducer, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical introducer, not an AI or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance testing was conducted.
8. The sample size for the training set: Not applicable, as no performance testing was conducted (and no training set would be relevant for a physical device in this context).
9. How the ground truth for the training set was established: Not applicable, as no performance testing was conducted.

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To facilitate endotracheal intubation in adult and pediatric patients where visualization of the glottis is inadequate.

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 subject device, the Frova Intubating Introducer is designed for establishing a pathway to introduce an endotracheal tube to a patient's airway. The intubation introducer is an 8 French, 35 cm long, single lumen catheter printed with incremental markings on the external surface. The introducer is made of radiopaque polyurethane and features a blunt and open distal tip with two sideports located on opposite sides of the distal tip. The introducer is compatible with an endotracheal tube with an inner diameter of 3.0 mm or larger.

The subject device intubation introducer is also preloaded with a stiffening stylet to provide extra stiffness to the introducer while it is being advanced into the patient's trachea. The stainless-steel stiffening stylet has an outer diameter of 0.051 inches and a length of 31 cm. A polyamide obturator hub is bonded to the stylet.

The subject device set also provides two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector) for ventilation when the oxygen requirement of a patient is high and the endotracheal tube is not in the trachea of the patient. The 15 mm Rapi-Fit adapter is intended for attachment to traditional ventilator sources that are low pressure sources, or so-called continuous positive airway pressure (CPAP) ventilators. The Luer Lock Rapi-Fit adapter is intended for attachment to a high-pressure jet ventilation oxygen source, and is compatible with a variable connector or the standard Luer fitting of an oxygen tube which is connected to an oxygen source.

Here's a breakdown of the acceptance criteria and the study information for the Frova Intubating Introducer, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Sets for Physical/Mechanical Tests (Catheter separation force, tensile strength, kink radius, radiopacity, stylet tensile): The document doesn't explicitly state the sample size for each of these tests. It generally refers to "test articles" or "specified catheter shaft section." Data provenance is not specified but is implied to be from laboratory testing.
• Test Set for Design validation for pediatric use (Manikin Study): The document states that "airway training manikins that resemble appropriate patient anatomy of different sub-groups were used." It does not specify the exact number of manikins used or the number of trials. The data provenance is implicitly from a laboratory or simulation setting.
• Test Set for Design validation for high pressure oxygenation (Breathing Simulator): The document mentions using the "ASL 5000 Breathing Simulator from IngMar Medical" to simulate breathing profiles for "infant (> 1 month to 2 years old), child (> 2 years to 12 years old), adolescent (> 12 years through 21 years old), and adult (> 21 years old) patient sub-groups." The sample size (e.g., number of simulations, repetitions) is not specified. Data provenance is from a laboratory / simulator setting.
• Test Set for Biocompatibility: The document states "Biocompatibility testing Per ISO 10993-1 and FDA guidance." The sample size for these specific tests (cytotoxicity, sensitization, etc.) is not detailed in this document.
• Test Set for Acute performance evaluation (Animal Study): The document mentions "animal study" but does not provide the specific animal model, number of animals, or design of the study. Data provenance is from an animal study.

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

The document does not mention the use of experts to establish ground truth for any of the described tests. The tests are primarily physical, mechanical, or simulation-based, or involve direct measurement against defined standards (e.g., ISO 5361, X-ray step wedge gauge).

4. Adjudication Method for the Test Set

Not applicable, as no expert-based ground truth establishment or subjective assessment requiring adjudication is described.

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

No, an MRMC comparative effectiveness study was not done or described in this document. The device is a medical introducer, not an AI or imaging diagnostic tool that would typically involve a multi-reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a physical medical introducer, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the various tests mentioned is based on:

• Engineering specifications and standards: For physical and mechanical tests (e.g., separation force, tensile strength, kink radius, radiopacity, stylet tensile), the ground truth is defined by specific numerical thresholds (e.g., >15 N) or compliance with international standards (ISO 5361).
• Simulated clinical performance: For pediatric use validation and high-pressure oxygenation studies, the ground truth is performance within expected physiological parameters or successful function in simulation models (manikins, breathing simulators).
• Biocompatibility standards: For biocompatibility, the ground truth is compliance with ISO 10993-1 and FDA guidance through specific toxicology tests.
• Animal study observations: For acute performance, the ground truth would be observed performance as intended in the animal model.

8. The Sample Size for the Training Set

Not applicable. The device is a medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. There is no training set mentioned for this device.

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The Frova Intubating Introducer is intended to facilitate endotracheal intubation in patients where the visualization of the glottis in inadequate. The 14 French catheter has been designed for placement of a single lumen endotracheal tube whose inner diameter is 6 mm or larger.

The Frova Intubating Introducer is a 14 French, 70 cm long radiopaque catheter introducer with centimeter markings and a blunt, curved tip that can be passed blindly into the trachea, when visualization of the glottis is inadequate and only visualization of the epiglottis can be confirmed by laryngoscopy. The catheter introducer has a tubular design with two distal sideports to ensure adequate airflow. It can be supplied with or without a stiffening stylet and/or two Rapi-Fit adapters for connection to a ventilator device. Pressure and flow specifications for the device when used for oxygenation are as follows: mean delivered minute volume is 8.6 L/min and mean measured average maximum airway pressure is 12.1 cm H2O (when input pressure is set to 50 psi, lung compliance is 100 mL/cm H2O, and resistance is 3 cm H2O/L/s). Incremental centimeter markings are placed on the shaft of the catheter introducer, with the first measurement marking designating 10 centimeters from the distal tip. The centimeter marks along the catheter shaft facilitate accurate depth placement of the catheter introducer into the airway.

The provided text describes the regulatory clearance of a medical device, the Frova Intubating Introducer, and includes details about its performance testing. However, it does not describe an AI/ML-driven device or diagnostic study.

Therefore, many of the requested elements for an AI/ML study (like sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details, or type of ground truth) are not applicable to this document.

The document details engineering and performance validation tests for a physical medical device.

Here's the information that can be extracted relevant to the acceptance criteria and device performance:

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

2. Characterized delivered minute volume during simulated high pressure oxygenation insufflation.
3. Successfully couples with Luer Lock Rapi-Fit adapter during simulated clinical use. | Characterization study performed, demonstrating the device's ability to insufflate oxygen, characterize delivered minute volume (mean 8.6 L/min, mean max airway pressure 12.1 cm H2O), and successful coupling with the Rapi-Fit adapter. |
   | Transportation - Part 1 (Visual Inspection) | Damages accepted on shipping boxes as long as product boxes are without holes/loose pieces or damages due to humidity. Small visible damages like pressure marks allowed on product boxes, as long as sterile barrier and Frova catheter are intact. | All acceptance criteria were met. |
   | Transportation - Part 2 (Sterile Barrier) | No breaches in sterile barrier, no visual tears or pinholes. | All acceptance criteria were met. |
   | Transportation - Part 3 (Device Integrity) | Catheter introducer has a curved tip after simulated shipping test. No kinks or damages. For C-CAE-14.0-70-FII, adapter attaches/locks to catheter introducer per IFU, not removable by pulling when locked, and removable from catheter introducer per IFU. | All acceptance criteria were met. |
   | Ink adherence and radiopacity | Each test article receives a rating of 2 or 3 on a 3-point scale for legibility of printed markings and radiopacity. | All acceptance criteria were met. (Performed as simulated use testing in domestic swine) |
   | Accelerated Age Testing | (Equivalent of three years real time aging) | |
   | Tensile strength (catheter introducer) | ≥ 15 N (accordance with EN/ISO 10555-1:2013) | Met |
   | Tensile strength (stiffening stylet) | ≥ 15 N (accordance with EN/ISO 10555-1:2013) | Met |
   | Tensile strength (catheter introducer/Rapi-Fit adapter connection) | ≥ 15 N (accordance with EN/ISO 10555-1:2013) | Met |
   | Kink radius (catheter introducer) | No kinking at 40 mm Radius of Curvature (according to Annex H of ISO 5361:2012) | Met |
   | Unscrewing torque (Luer Lock) | Female Luer connection remains attached to reference fitting (ISO 594-2, Section 5.5) | Met |
   | Resistance to overriding (Luer Lock) | Reference fitting does not override threads of conical fitting (ISO 594-2, Section 5.7) | Met |
   | Separation Force (Luer Lock) | Remains attached to the reference fitting (ISO 594-2, Section 5.4) | Met |
   | Compliance verification (15mm adapter) | Leading edge of 15 mm Rapi-Fit adapter lies between minimum and maximum diameter step gauges (ISO 5356-1:2015, Section 3.1.2) | Met |
   | Sterile barrier and dimensional verification | Sterile barrier intact (bubble leak/dye test). Product appears intact visually. Tip angle within tolerances. Length 70 cm ± 3mm. ID 3.124 mm ± 0.05 mm. OD 4.674 mm ± 0.05 mm. Print clear and visible within tolerances. Rapi-Fit adapters attach and lock per IFU. | All acceptance criteria were met. |
   | Ink adherence and radiopacity | Each test article receives a rating of 2 or 3 on a 3-point scale for legibility of printed markings and radiopacity. | All acceptance criteria were met. (Performed as simulated use testing in domestic swine) |
   | Biocompatibility | | |
   | Cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material mediated pyrogenicity | Passed results in accordance with ISO 10993-1:2009 and FDA guidance. | All biocompatibility tests showed passed results. |
   | Volatile organic compounds (VOCs) | No VOCs detected greater than quantification limits; no additional VOCs detected. | No VOCs detected greater than quantification limits; no additional VOCs detected. Risk assessment determined negligible likelihood of toxic effect. |
   | Particulate matter emission | Presents a clinically insignificant health risk to patients. | Results demonstrated clinically insignificant health risk. |

Regarding the AI/ML-specific questions:

2. Sample size used for the test set and the data provenance: Not applicable; this is not an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; this is not an AI/ML device.
4. Adjudication method: Not applicable; this is not an AI/ML device.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an AI/ML device.
7. The type of ground truth used: For physical characteristics, the ground truth is established by physical measurement against established specifications (e.g., tensile strength, dimensions, kink radius, Luer Lock standards, adapter fit, sterile barrier integrity). For biological safety, it's defined by the results of standardized biocompatibility tests. For simulated use, it involves performance ratings in a simulated environment or animal model (domestic swine).
8. The sample size for the training set: Not applicable; this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable; this is not an AI/ML device.

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