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The devices are indicated for airway management in patients, during surgical procedures involving the head, neck, or mouth, to provide a clear surgical field by directing the circuit and connectors away from the operative area and reduce the risk of kink.

The subject device of this premarket 510(k) notification is referred to as Shiley™ Oral/Nasal RAE Tracheal Tube, Murphy Eye. The Shiley™ Oral/Nasal RAE Tracheal Tube, Murphy Eye has a translucent polyvinyl chloride (PVC) tube shaft with a radiopaque filament along its length. The subject device is offered as cuffless or cuffed in various sizes, for either oral or nasal use. All tubes are single use, sterilized by ethylene oxide, and supplied with a standard 15mm connector. The subject device and its packaging are not made with rubber latex or DEHP.

Five families of the subject devices share the same indications for use and intended use but differ in specific design features such as size, cuff presence, cuff shape, and number of murphy eyes.

a) Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye
b) Shiley™ Nasal RAE Tracheal Tube Cuffless Murphy Eye
c) Shiley™ Oral RAE Tracheal Tube Cuffed Murphy Eye
d) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff Murphy Eye
e) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff Murphy Eye

N/A

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These devices are intended for oral or nasal intubation and are indicated for use in airway management, including those procedures requiring flexing of the neck or movement of the patient (e.g., to a lateral or prone position).

The subject devices are sterile, single-use tracheal tubes that incorporate a pre-formed Magill curve and have a continuous stainless-steel spiral wire incorporated into the wall to reduce the risk of collapse or kinking during patient positioning. All tracheal tubes feature standard depth marks, glottic depth marks and 15mm connector. The cuffed devices are provided with two different low-pressure cuff types, featuring a thin compliant wall that, when inflated, adapts and conforms to the irregular borders of the tracheal wall. The cuffed devices have an inflation system consisting of an inflation line, pilot balloon and self-sealing inflation valve, allowing for inflation and deflation of the cuff.

Five families of the subject devices share the same indications for use and intended use but differ in specific design features such as size, cuff presence, cuff shape, presence of murphy eye and stylet.

N/A

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The Aero Jet Ventilation Catheter is indicated to be used as a device for ventilating the patient by the administration of oxygen and air, a technique referred to as jet ventilation.

The Aero Jet Ventilation Catheter is a sterile, single-use, prescription medical device that consists of a three lumen PTFE extrusion, a PEBAX centering feature at the distal end, three (3) MABS female luer connectors, silicone extrusion to connect the connectors to the main shaft, and four (4) polyolefin color coded marker bands for identification of connectors and depth marking. A removable stainless-steel stylet is included to support the device during insertion. It has a nominal insertion length of 23 cm and nominal OD of 3.85 mm. It is inserted orally and placed subglottic. It provides jet ventilation and allows for monitoring of pressure and EtCO2.

This document is a 510(k) clearance letter for a medical device called the "Aero Jet Ventilation Catheter." 510(k) clearances are for demonstrating substantial equivalence to a predicate device, not for proving new claims of safety and effectiveness through clinical trials with strict acceptance criteria based on new performance metrics.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the way described in the prompt (e.g., related to AI/algorithm performance, MRMC studies, specific effect sizes, ground truth establishment, or sample sizes for test/training sets in the context of diagnostic/AI performance).

The "performance testing summary" in the document refers to standard engineering and biocompatibility tests to show the device functions as intended and is safe, similar to the predicate device. It is not a study to establish performance against specific clinical or diagnostic metrics with human readers or AI in the way implied by the prompt's detailed questions.

Based on the provided text, I cannot complete the table or answer the questions as they pertain to a study proving device performance against acceptance criteria in a clinical/diagnostic context (like an AI study). The 510(k) process for this device relies on demonstrating equivalence to an existing device, primarily through engineering and bench testing, not through comparative clinical studies as you've outlined for diagnostic/AI devices.

Here's what I can extract from the document regarding "acceptance criteria" in the context of a 510(k) submission for this type of medical device:

The acceptance criteria for a 510(k) submission for a device like the Aero Jet Ventilation Catheter are implicitly tied to demonstrating substantial equivalence to a predicate device. This typically involves showing:

• Same Indications for Use: The new device is intended for the same uses as the predicate.
• Same Technological Characteristics: The new device has similar design, materials, and operating principles.
• Differences Do Not Raise New Questions of Safety/Effectiveness: If there are differences, testing must show they do not negatively impact safety or effectiveness.

The "studies" performed are primarily non-clinical functional and performance testing alongside biocompatibility testing. These tests are designed to show that the device performs its intended mechanical functions reliably and safely, and interacts biocompatibly with the body, similar to the predicate.

Therefore, the table and answers below reflect the type of "acceptance criteria" and "proof" found in this specific 510(k) document, which differs significantly from criteria for AI/diagnostic performance studies.

Acceptance Criteria & Device Performance (Based on K243579)

Since this is a 510(k) for a physical medical catheter, the "acceptance criteria" are not focused on diagnostic accuracy or AI performance, but rather on physical and functional characteristics to demonstrate substantial equivalence to a predicate device. The "performance" is implicitly tied to meeting these engineering and biocompatibility standards.

Table of Acceptance Criteria and the Reported Device Performance

Since the request focuses on information typically found in studies for AI/diagnostic devices, and this 510(k) is for a physical catheter, most of the specific numbered questions are not applicable (N/A) to the provided document.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Sample Size: Not explicitly stated for each bench test. For engineering/bench tests, "sample size" refers to the number of devices or components tested. These are laboratory tests, not clinical data sets.
* Data Provenance: N/A (These are laboratory bench tests of manufactured devices, not clinical data from patients/regions). The tests are performed on samples of the manufactured device.
* Retrospective/Prospective: N/A (Refers to clinical data collection, not bench testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
* N/A. This applies to clinical interpretation or AI ground truth. For a physical device, "ground truth" is established by engineering specifications, validated test methods (e.g., ISO standards), and physical measurements. Expertise would lie with engineers, material scientists, and quality control professionals who design and conduct the tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* N/A. This applies to human reader disagreements in clinical studies. Bench testing results are typically objectively measured against pre-defined engineering tolerances and test protocols.

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
* N/A. No MRMC study was done, as this is a physical medical device, not an AI or diagnostic imaging device. The document explicitly states: "No animal or clinical studies were conducted for this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* N/A. No algorithm or AI component is listed for this physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* N/A. As a physical device, "ground truth" for the performance tests (e.g., tensile strength, flow rate, dimensions, laser resistance) is based on:
* Engineering Specifications: Designed values and tolerances.
* International Standards (e.g., ISO): Predetermined test methods and acceptable limits (e.g., for biocompatibility, connector integrity, laser resistance).
* Physical Measurements: Direct measurements of device properties.

8. The sample size for the training set
* N/A. This refers to training data for an algorithm. This device does not use a "training set."

9. How the ground truth for the training set was established
* N/A. This refers to ground truth for training an algorithm. Not applicable to this physical device.

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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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The ProVu Endotracheal Tube with Video Stylet is intended for intubation procedures. The ProVu Endotracheal Tube with Video Stylet is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.

The ProVu Endotracheal Tube with Video Stylet is indicated for viewing during non-difficult and difficult intubation procedures and for verifying endotracheal tube placement.

The ProVu Video Stylet with Reinforced ET Tube is a sterile, single-use, video-enabled stylet and ETT intubation system with malleable and directional control intended to assist with oral and nasal intubations and designed for use in adults in a hospital environment.

The device comprises of two main components:

• The ProVu Reinforced Endotracheal tube
• The ProVu Video Stylet (with a removable malleable rod)

The provided FDA 510(k) clearance letter and summary for the ProVu Single Use Video Stylet with Reinforced ET Tube does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to its clinical performance or diagnostic accuracy.

The summary focuses on non-clinical data to demonstrate substantial equivalence to a predicate device. This typically means the device has similar technological characteristics and indications for use, and does not raise new questions of safety or effectiveness. The included sections detail biocompatibility, sterilization, electrical safety, bench performance, and usability, but none of these address how well the device performs its intended clinical function (e.g., successful intubation, accurate verification of tube placement) against specific performance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the given text.

Here's an analysis of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided. The summary lists standards the device complies with (e.g., ISO 5361, IEC 60601-1), which are design and safety standards, not clinical performance acceptance criteria.
2. Sample size used for the test set and the data provenance: Not provided. No test set for clinical performance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No ground truth for clinical performance is mentioned.
4. Adjudication method for the test set: Not provided. No clinical test set is mentioned.
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 not an AI-assisted diagnostic tool for "human readers" in the sense of image interpretation. It's a video stylet for direct visualization during intubation. The concept of "AI assistance" and "effect size of human readers" doesn't apply to the reported information.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device. It's a physical medical device that assists human operators in a procedure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. No clinical ground truth is mentioned.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

Summary of what was reported in the 510(k) information:

• Non-clinical data provided:
  • Biocompatibility testing: Evaluated per ISO 10993-1 and ISO 18562 (Cytotoxicity, Sensitization, Intracutaneous reactivity, Material Mediated Pyrogenicity, Subcutaneous Implantation, Chemical Characterisation, Toxicological Risk Assessment, Gas Pathway Testing).
  • Sterilization and shelf-life testing: Validated according to ISO 11135:2014, EO/ECH residual test per ISO 10993-7:2008. Shelf-life of 0.5 year.
  • Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1, IEC60601-2-18, and IEC 60601-1-2.
  • Bench performance testing: Complies with ISO 5361, ISO 5356-1.
  • Usability validation: Conducted according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices".
• Clinical Study: Explicitly stated as "Not applicable."

This is characteristic of a 510(k) submission where substantial equivalence is demonstrated through non-clinical performance and technological comparison, rather than requiring new clinical efficacy or effectiveness data.

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The LMA® Fastrach™ ETT Single Use is indicated for tracheal intubation through the LMA® Fastrach™.

The Stabiliser Rod is indicated for use during removal of the LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the LMA® Fastrach ™ ETT Single Use in place.

The LMA® Fastrach™ ETT Single Use has been developed specifically for use with the LMA® Fastrach™. It is a straight, cuffed, wire-reinforced tube with a Murphy Eye and a standard 15mm connector.

The LMA® Fastrach™ ETT Single Use has a pilot balloon with a luer check valve and a unique, soft, moulded tip for atraumatic passage through the vocal cords. As a reference during intubation, the LMA® Fastrach™ ETT Single Use has depth markers to indicate the distance to the distal tip of the LMA™ airway. The LMA® Fastrach™ ETT Single Use is radiopaque along its full length and its tip is made out of a radio opaque material to enhance its visibility in x-rays.

Accessory device: The Stabiliser Rod Single Use is an accessory and it is indicated for use during removal of the reusable LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the Endotracheal Tube (ETT) in place.

The provided 510(k) clearance letter and summary for the LMA Fastrach ETT SU is for a medical device (a tracheal tube), not a diagnostic AI/ML algorithm. Therefore, the information typically required for describing the acceptance criteria and study proving an AI/ML device meets those criteria (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not present in this document.

The document focuses on demonstrating substantial equivalence to a predicate device, as is standard for 510(k) submissions of traditional medical devices. This is achieved primarily through:

• Comparison of features: Highlighting similarities in classification, product code, regulation number, size range, cuffed design, radiopacity, sterilization method, and eye (Murphy).
• Performance data (bench testing): Verifying that the new device performs similarly to the predicate in terms of physical characteristics and durability.

Here's an analysis of the provided text in the context of your request for AI/ML device study details:

Acceptance Criteria and Device Performance (Based on provided text for a non-AI/ML device):

The "acceptance criteria" for this traditional medical device are primarily about demonstrating that it is substantially equivalent to a legally marketed predicate device and that it meets established engineering performance standards for tracheal tubes. The "device performance" is shown through bench testing.

Addressing your specific points for an AI/ML device study (based on the absence of this information in the document):

1. A table of acceptance criteria and the reported device performance: As seen above, for a mechanical device, these are primarily about physical and material properties and substantial equivalence, not performance metrics like sensitivity/specificity for an AI/ML diagnostic.
2. Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing of a physical medical device. No "test set" of patient data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical tube's performance is established by engineering and material science standards, not expert medical opinion on a data set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudicators are mentioned as this is not a diagnostic device relying on interpretation.
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 a stand-alone physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a traditional mechanical device, "ground truth" is established by engineering standards, material specifications, and physical measurements (e.g., tensile strength, dimensional accuracy, sterilization efficacy).
8. The sample size for the training set: Not applicable. This device is not developed using machine learning; therefore, there is no "training set."
9. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.

Conclusion from the provided document:

The provided FDA 510(k) clearance letter and summary pertain to a traditional medical device (a tracheal tube), not a software as a medical device (SaMD) or an AI/ML-driven diagnostic tool. Therefore, the document does not contain the information relevant to AI/ML device performance studies, such as data provenance, expert adjudication, or MRMC studies. The "acceptance criteria" and "proof" in this context are based on a demonstration of substantial equivalence to a predicate device and successful completion of standard bench testing for physical and material properties.

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Reinforced Tube: Rusch Reinforced Endotracheal Tubes are designed for nasal intubation and are indicated for airway management. The correct designation (oral, nasal or oral/nasal) is printed on the tube and unit package. Reinforced Endotracheal Tubes may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. The Reinforced Endotrached to be used on all patients requiring ventilation, pediatric and adult.

Safety Clear and Safety Clear Pediatric Tubes: Rusch Endotracheal Tubes, Cuffed and Uncuffed, with or without Murphy Eye are for oral or nasal intubation. They are indicated for airway management. The Rusch Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult.

An endotracheal tube is a device that is inserted into the trachea via the nose or the mouth to establish a patent airway to allow ventilation. The proposed Teleflex Medical Rusch Endotracheal Tubes are sterile, single use devices that are made non made with DEHP. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the Safety Clear tracheal tube, while the Reinforced tube contains an embedded stainless-steel spiral that allows for X-ray visualization. Each tracheal tube is supplied with an appropriately sized 15mm connector.

The provided document is a 510(k) Premarket Notification from Teleflex Incorporated to the FDA regarding their Rusch Endotracheal Tubes. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Crucially, this document does NOT describe a study that involves AI or machine learning, human readers, or image-based diagnostics. The "device" in question is an endotracheal tube, a physical medical device, not a software or AI-driven diagnostic tool.

Therefore, many of the requested criteria related to AI/ML model performance, such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.

The "acceptance criteria" and "device performance" in this context refer to the physical and biological characteristics of the endotracheal tube, verified through standard bench testing and biocompatibility assessments, rather than diagnostic accuracy or reader improvement.

Here's an attempt to fill in the relevant information based on the provided text, while clearly stating when information is Not Applicable (N/A) due to the nature of the device:

Acceptance Criteria and Device Performance Study for Rusch Endotracheal Tubes

This submission focuses on establishing substantial equivalence for physical medical devices (endotracheal tubes), not software or AI-driven diagnostic tools. Therefore, many standard AI/ML study components are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the successful completion of the described bench testing and biocompatibility assessments, demonstrating that the device performs as intended and is safe for its indicated use. The "reported device performance" is the successful fulfillment of these tests, confirming substantial equivalence to the predicate devices.

| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance (as implied by acceptance) |
|------------------------------|----------------------------------------------------------------+|--------------------------------------------------------|
| Physical Performance | Visual inspection | Acceptable |
| | Dimensional testing | Within specifications |
| | Bonding strength (main tube to side arm, inflation tube, connector) | Acceptable |
| | Tube curvature | Acceptable |
| | Cuff restrained burst | Acceptable |
| | Bevel angle | Acceptable |
| | Cuff inflation | Acceptable |
| | Kink resistance | Acceptable |
| | Cuff herniation | Acceptable |
| | Cuff diameter | Acceptable |
| | Tube collapse | Acceptable |
| | Tracheal seal testing | Acceptable |
| Biocompatibility | Cytotoxicity (ISO 10993) | Pass |
| | Sensitization (ISO 10993) | Pass |
| | Irritation (ISO 10993) | Pass |
| | Acute Systemic Toxicity (ISO 10993) | Pass |
| | Material Mediated Pyrogenicity (ISO 10993) | Pass |
| | Implantation (ISO 10993) | Pass |
| | Subacute Systemic Toxicity (ISO 10993) | Pass |
| | Genotoxicity (ISO 10993) | Pass |
| | Chemical Characterization (Exhaustive & Simulated Use) | Pass (Toxicological Risk Assessment Related to Extractables and Leachables) |
| | Particulates and VOC | Pass (Toxicological Risks Related to Inhalation of VOCs and Particulates) |

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of tubes) used for each bench test or biocompatibility test. It indicates that "testing performed verifies that the performance of the subject device is substantially equivalent." For biocompatibility, it states "Materials have been tested per ISO 10993-1" and lists the tests performed, implying standard sample sizes as per the ISO standard.
• Data Provenance: The data provenance is from internal testing conducted by Teleflex Medical, Inc. (the manufacturer). The type of data is physical testing and chemical/biological analysis of device materials. It is implicitly "prospective" in the sense that the testing was performed on newly manufactured devices for the purpose of this submission. Country of origin not specified, but likely where Teleflex manufactures or tests its products, or where the testing labs are located.

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

• Not Applicable (N/A): For a physical device like an endotracheal tube, "ground truth" is established through standardized engineering specifications, material science, and regulatory standards (e.g., ISO standards). It does not involve expert readers reviewing output in the same way an AI diagnostic tool would. The experts involved would be engineers, material scientists, and toxicologists conducting the testing and interpreting the results against established physical and biological acceptance criteria.

4. Adjudication Method for the Test Set

• Not Applicable (N/A): As there is no human interpretation or subjective assessment of "ground truth" images or data points (as in an AI diagnostic study), there is no adjudication method in the context of multiple expert readers. Compliance is determined by objective measurements against predefined engineering and biological limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: This is a physical medical device; an MRMC study is not relevant.

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

• Not Applicable (N/A): This submission is for a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Results: The "ground truth" for this medical device is based on established engineering specifications for physical characteristics (e.g., dimensions, bond strength, kink resistance, cuff performance) and adherence to recognized international standards for biocompatibility (ISO 10993 series). The device's performance is measured against these objective criteria rather than expert consensus on a diagnostic outcome.

8. The Sample Size for the Training Set

• Not Applicable (N/A): This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

• Not Applicable (N/A): As there is no training set, this question is not applicable.

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Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP is intended for oral or nasal intubation of the trachea.
The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP is intended for use in oral or nasal intubation of the trachea for anesthesia and is indicated for airway management.

The subject device is an oral/nasal endotracheal tube intermediate cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) high pressure, low volume cuff with two different cuff shapes. An inflation system consisting of an inflation line, pilot balloon, and inflation valve allows inflation and deflation of the cuff. The subject device is manufactured from materials without latex or DEHP.

This document is a 510(k) Summary for the Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP, and it details the device's substantial equivalence to predicate devices, supported by performance data.

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

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact sample sizes for each bench test conducted. It states that "terminally sterilized samples" were tested. For biocompatibility, it mentions "testing was performed on final finished subject device" for sizes 8.5mm to 10.0mm, and testing from the predicate device was leveraged for sizes 3.0mm to 8.0mm.
• Data Provenance: The document does not provide details on data provenance such as country of origin or whether the studies were retrospective or prospective. It describes laboratory bench testing and biocompatibility testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable as the document describes bench testing and biocompatibility assessments, which do not typically involve human experts establishing a "ground truth" in the way clinical studies or diagnostic AI studies do. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified international standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As stated above, this pertains to objective bench and biocompatibility testing following established international standards, not clinical adjudication by experts.

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. A MRMC comparative effectiveness study was not performed. This document describes the clearance of a physical medical device (an endotracheal tube), not an AI-powered diagnostic tool.

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

Not applicable. This device is an endotracheal tube; it does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance data in this submission consists of the acceptance criteria defined by international consensus standards (ISO 5361, ISO 5356, ISO 18190, ISO 10993-1) and specific test protocols for mechanical properties, biocompatibility, and sterilization, along with human factors standards (EN 62366-1).

8. The sample size for the training set

Not applicable. This document describes the clearance of a physical medical device (an endotracheal tube), not a machine learning model that requires a training set.

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

Not applicable. See point 8.

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The Shiley™ pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non DEHP is intended for use in facilitating oral or nasal intubation of the trachea.

The subject device is pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) low pressure taper-shaped cuff (TaperGuard™) to provide air and fluid seal. An inflation system consisting of an inflation line, pilot balloon, and inflation valve allows inflation and deflation of the cuff. The subject device is manufactured from materials without latex or DEHP.

The provided document describes the Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP, and its substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, a direct response to your request, which focuses on acceptance criteria and studies for AI/ML devices, cannot be fully generated from the provided text.

The document does not contain information on:

• Sample sizes for test sets (training or test data)
• Data provenance (country of origin, retrospective/prospective)
• Number of experts, their qualifications, or adjudication methods for ground truth
• Multi-reader multi-case comparative effectiveness studies
• Standalone algorithm performance
• How ground truth was established for "training sets" (as this is not an ML device)

However, I can extract the acceptance criteria and the performance results for the physical device based on the information provided in the "PERFORMANCE DATA" section.

Acceptance Criteria and Reported Device Performance

Study Information (Based on available document sections):

This document describes a medical device clearance for an endotracheal tube, not an AI/ML powered device. Therefore, the specific questions related to AI/ML device studies (such as sample sizes for AI training/test sets, data provenance for AI, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to the provided content.

The studies conducted were bench-top performance testing, biocompatibility testing, and a human factors/usability study to demonstrate substantial equivalence to predicate devices and compliance with relevant ISO standards.

• Type of Ground Truth Used: For the physical device, the "ground truth" is defined by compliance with established engineering and medical device standards (e.g., ISO 5361:2016, ISO 10993-1:2009, IEC 62366-1:2015) and comparison to the performance of predicate devices. There is no "ground truth" of the kind used for AI/ML validation (e.g., expert consensus on medical images or pathology results).
• Sample Size for Training Set & Ground Truth for Training Set: These concepts are not applicable as this is not an AI/ML device. The "training" for this device would be its design and manufacturing process, optimized to meet design specifications and regulatory standards.

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WEI nasal jet tube is indication for airway management, inserted through nasal cavity. During and after insertion, the Jet Tube can supply jet ventilation intermittently. When the Jet tube is not in use, the main tube serves as the main oxygen supply channel, and oxygen is supplied through main tube. The PetCO2 Monitor tube can connect to CO2 monitoring machine to monitor CO2 status.

Wei Nasal Jet Tube is a sterile, single-use nasopharyngeal airway management, monitor PetCO2 and mechanical ventilation. Wei Nasal Jet Tube inserted into a patient's pharynx through the nose, it provides active, pulsatile and powerful supraglottic jet oxygenation and ventilation (SJOV) via a jet channel built into the wall of its distal end. It can be used to monitor PetCO2 via another channel built into the wall and open to the middle lumen of the tube. Wei Nasal Jet Tube can also augment oxygen supplies for patients with respiratory suppression or apnea during difficult airway managements.

The provided text pertains to a 510(k) Premarket Notification for the "Wei Nasal Jet Tube" and describes non-clinical performance testing. It does not describe a study that proves the device meets acceptance criteria for an AI/ML powered medical device. Therefore, I cannot extract the information required to answer your query regarding AI/ML device acceptance criteria and study details.

The document focuses on:

• Substantial Equivalence (SE) determination: Comparing the proposed device to a predicate device (Boussignac/Vygon Endotracheal Tube).
• Non-clinical performance testing: This includes physical dimension tests (length, diameter, curvature, bevel angle, kink resistance), connector strength tests, and biocompatibility tests, sterilization validation, and shelf-life studies.
• No clinical study: The document explicitly states, "No clinical study is included in this submission." ([Page 11])

The provided text does not contain any information about:

• An AI/ML powered medical device.
• Acceptance criteria for an AI/ML device (e.g., sensitivity, specificity, accuracy).
• A test set, training set, or ground truth establishment for an AI/ML model.
• Expert involvement (number, qualifications, adjudication methods) for ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided input.

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