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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 EMG tube is indicated for use where continuous monitoring of the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.

Medtronic Xomed, Inc.'s NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes are flexible, reinforced endotracheal tubes with inflatable cuffs. The NIM EMG ET Tubes are made from silicone elastomer. Each tube is fitted with electrodes on the main shaft, which are exposed only for a short distance, slightly superior to the cuff. The electrodes are designed to make contact with the laryngeal muscles around the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to an EMG monitoring device. Both the tube and cuff are manufactured from material that allows the tube to conform readily to the shape of the patient's trachea with minimal trauma to tissues.

The provided text describes a 510(k) premarket notification for the Medtronic Xomed, Inc. NIM Standard Reinforced EMG Endotracheal Tube and NIM CONTACT Reinforced EMG Endotracheal Tube. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a de novo device meets specific performance criteria through extensive clinical studies.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and a study proving a device meets them that one would find for a novel device or an AI/ML-based device seeking de novo authorization or PMA. Specifically, it lacks:

• A table of acceptance criteria and reported device performance: This document focuses on demonstrating equivalence to predicate devices, not on meeting predefined performance metrics for a novel technology.
• Sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or type of ground truth for a test set. These elements are typically found in studies designed to validate the performance of a diagnostic or therapeutic device against a gold standard, especially for AI/ML products.
• Sample size for the training set or how ground truth for the training set was established: This information is pertinent to machine learning models, which are not the subject of this 510(k) submission.

What the document does describe regarding "performance data" is limited to nonclinical testing for usability and labeling design validation to support substantial equivalence.

Here's an analysis of the "Performance Data" section based on the provided text:

1. Acceptance Criteria and Reported Device Performance:

The document does not present quantitative acceptance criteria for the device's technical or diagnostic performance in the way one would see for a novel medical device like an AI algorithm. Instead, the "acceptance" is tied to proving substantial equivalence to predicate devices. The performance data presented relates to usability and labeling effectiveness, which are indirectly linked to safety and effectiveness.

• Usability Goal: "The Anesthesiologist/Nurse Anesthetist shall be able to intubate the patient and maintain the airway without introducing any unrealized use errors or critical tasks."
• Critical Tasks: "Confirm the Critical tasks were completed without any unacceptable Use Error that may have resulted in unmitigated potential hazards."
• Risk Mitigations: "To show the risk mitigations were effective in regard to labeling and training."
• Labeling Design Validation User Need: "The product labeling was to be understandable and provide needed information for proper safe and effective use of the device."

Reported Performance:
"The results of these validations with the modified proposed labeling demonstrated that the usability goal was achieved, all critical tasks were completed without introducing any additional unmitigated hazards, the user need and risk control measures were met and the training mitigations proposed were effective."

2. Sample Sizes and Data Provenance:

The document mentions "Summative Usability Validation" and "Labeling Design Validation" but does not specify the sample size (e.g., number of users, number of simulated scenarios) used for these nonclinical tests.
The data provenance is implied to be from internal testing conducted by the manufacturer, Medtronic Xomed, Inc., as part of their 510(k) submission process. It is not retrospective or prospective clinical data in the typical sense. The country of origin of the data is not explicitly stated but is implied to be in the US, given the FDA submission.

3. Number of Experts and Qualifications:

The document refers to "Anesthesiologist/Nurse Anesthetist" as the target users for the usability testing. However, it does not specify the number of experts used in the usability or labeling validation studies, nor their specific qualifications (e.g., years of experience). These individuals would have served as the "test subjects" or "evaluators" for the usability study, not necessarily as "experts establishing ground truth" in a diagnostic context.

4. Adjudication Method:

The document does not mention any adjudication method. This is not relevant for the type of usability and labeling validation studies described. Adjudication is typically used in studies where multiple human readers or algorithms produce interpretations that need to be reconciled to establish a ground truth (e.g., for diagnostic accuracy studies).

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

No MRMC study was conducted or reported. The device is not an AI/ML diagnostic aid that assists human readers. It is an endotracheal tube with EMG monitoring capabilities. The "performance data" is purely for usability and labeling effectiveness, not comparative diagnostic accuracy for human readers with or without an AI.

6. Standalone Performance (Algorithm Only):

This section is not applicable. The device is a physical medical device (an endotracheal tube), not a software algorithm. Therefore, there is no "standalone performance" in the context of an algorithm's output.

7. Type of Ground Truth Used:

For the usability and labeling studies, the "ground truth" was essentially defined by the successful completion of critical tasks without unacceptable use errors and the understandability of the labeling, as determined by the study design and its evaluators. This is not "expert consensus," "pathology," or "outcomes data" in the clinical diagnostic sense. It's about demonstrating safe and effective interaction with the device.

8. Sample Size for the Training Set:

This is not applicable. The device is a physical product, not an AI/ML model that requires a training set.

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

This is not applicable for the same reason as above.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, with performance data limited to nonclinical usability and labeling validation. It does not provide the details typically found in studies for novel diagnostic or AI/ML devices that aim to prove specific performance metrics against a clinical ground truth.

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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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Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal chest X-rays acquired on a digital x-ray system.

Critical Care Suite with the Endotracheal Tube Position produces an on-screen image overlay that detects and localizes an endotracheal tube, locates the endotracheal tube tip, locates the carina, and automatically calculates the vertical distance between the endoracheal tube tip and carina. This information is also transmitted to the radiologist for review.

Intended users include licensed qualified healthcare professionals (HCPs) trained to independently place and/or assess endotracheal tube placement and radiologists.

Critical Care Suite with the Endotracheal Tube Positioning AI Algorithm should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to review of the X-ray image by a qualified healthcare professional. Critical Care Suite with the Positioning AI Algorithm is indicated for adult-sized patients.

Critical Care Suite with Endotracheal Tube Positioning Al Algorithm is an additional AI Algorithm incorporated into the Critical Care Suite software previously cleared under K183182. It introduces the Endotracheal Tube Positioning Al Algorithm which is a quantification tool that analyzes frontal chest x-ray images and based on the data in the image determines the location of the tip of an intubated patient's endotracheal tube, determines the location of the carina, and then calculates and displays the vertical distance between them. The distance provided is within the x-ray detector imaging plane and does not take into account the geometric magnification resultant from the geometry of the x-ray acquisition based on source to image distance (SID), patient size, or any impacts due to patient rotation or tube rotation. This information can aide clinical care teams and radiologists to determine the proper placement of the endotracheal tube in an intubated patient. All algorithms previously cleared under K183182 are still available with Critical Care Suite, including the Pneumothorax Detection Algorithm for triage and notification. The benefit of the proposed modification is not specific to the platform on which it is deployed. This benefit applies to all previously cleared computational platforms for Critical Care Suite, including PACS, On Premise, On Cloud and Digital Projection Radiographic Systems. The Optima XR240amx was chosen as the initial platform for deployment because endotracheal tube placement images are almost exclusively acquired on mobile X-ray systems due to the immobilization of the patients being intubated with an endotracheal tube.

Here's a breakdown of the acceptance criteria and the study details for the Critical Care Suite with Endotracheal Tube Positioning AI Algorithm, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "the results met the defined passing criteria." While specific numerical acceptance thresholds are not explicitly listed in the text, the reported high performance metrics imply that these values exceeded the internal acceptance criteria set by the manufacturer.

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

• Test Set Sample Size: The document states that the ground truth dataset contained a "sufficient number of images to adequately analyze all the primary and secondary endpoints." However, the exact sample size for the test set is not explicitly provided in the given text.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It only mentions the use of a "ground truth dataset."

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

The document does not explicitly state the number of experts used to establish the ground truth for the test set, nor does it provide their specific qualifications (e.g., radiologist with X years of experience).

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) used for establishing the ground truth of the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted or described in the provided document. The clinical tests focused on the standalone performance of the AI algorithm against a ground truth dataset, not on comparing human reader performance with and without AI assistance.

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

Yes, a standalone study was done. The "Summary of Clinical Tests" section explicitly describes the performance of the Endotracheal Tube Positioning AI Algorithm tested against a ground truth dataset, reporting metrics like AUC, sensitivity, specificity, and success rates for localization and measurement. This indicates a standalone evaluation of the algorithm's performance without direct human-in-the-loop comparison for these specific metrics.

7. The Type of Ground Truth Used

The type of ground truth used is expert consensus. The document refers to the algorithm's performance being "tested against a ground truth dataset" without specifying the exact method of ground truth establishment (e.g., pathology, outcomes data). However, for image analysis tasks like ETT positioning and carina localization, ground truth is typically established by multiple experts (e.g., radiologists) providing annotations or measurements, often followed by an adjudication process to reach a consensus.

8. The Sample Size for the Training Set

The document does not explicitly provide the sample size for the training set. It mentions the algorithms being "trained with clinical and/or artificial data" but no specific numbers.

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

The document states that the algorithms are "trained with clinical and/or artificial data." It does not explicitly detail how the ground truth for the training set was established. It refers to "nonadaptive machine learning algorithms trained with clinical and/or artificial data," but the process of creating the ground truth annotations for this training data is not described.

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The Tenax® Laser Resistant Endotracheal Tube is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns), KTP (532 nm) or Blue Laser (445mm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthetic gases or to overcome emergency obstruction of an airway.

The Tenax® Laser Resistant Endotracheal Tube is an endotracheal tube with two inflatable cuffs. It is indicated for use in surgical procedures where intubation is required in the presence of KTP, 445nm Blue Laser, or CO2 lasers. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations. There are no associated device accessories.

This document is a 510(k) premarket notification for a modification to a medical device, specifically the Tenax® Laser Resistant Endotracheal Tube. It primarily addresses the addition of 445 nm Blue Laser compatibility to the device's indications for use.

Based on the provided text, here's information related to acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide specific details about the sample size used for the test set of the laser resistance testing. It simply states "Laser resistance" as performance data.
The document does not specify data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This document is a regulatory submission for a medical device (endotracheal tube) and focuses on engineering/performance testing, not on clinical interpretation or AI model accuracy that would require expert-established ground truth. Therefore, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

This document is a regulatory submission for a medical device (endotracheal tube) and focuses on engineering/performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving expert reviews of diagnostic images/interpretations. This information is not applicable and not provided in the document.

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

No. This document does not describe a multi-reader multi-case comparative effectiveness study. This type of study is relevant for AI-driven diagnostic tools, not for a physical medical device like an endotracheal tube.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This document does not describe a standalone algorithm performance study. This type of study is relevant for AI-driven diagnostic tools, not for a physical medical device like an endotracheal tube.

7. Type of Ground Truth Used

The "ground truth" for this device's performance would be established through a combination of engineering specifications, material science testing, and laser interaction physics rather than expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices. The document mentions "verification and validation testing" which implies objective measurement against predefined technical requirements for laser resistance and other physical characteristics.

8. Sample Size for the Training Set

This document does not refer to a training set. The "Tenax® Laser Resistant Endotracheal Tube" is a physical medical device, not an AI/machine learning algorithm that requires training data.

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

Not applicable, as there is no training set for this physical medical device.

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The Tenax® Laser Resistant Endotracheal Tube is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns) or KTP (532 nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthetic gases or to overcome emergency obstruction of an airway.

The Tenax® Laser Resistant Endotracheal Tube is an endotracheal tube with two inflatable cuffs. It is indicated for use in surgical procedures where intubation is required in the presence of KTP or CO2 lasers.

The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations. There are no associated device accessories.

The provided text is a 510(k) premarket notification for a medical device and describes various tests performed to demonstrate substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific acceptance criteria in a clinical or AI performance context.

Therefore, much of the requested information (like sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness, standalone performance, and training set details) is not applicable or cannot be extracted from this document, as it pertains to specific types of clinical or AI performance studies which are not described here.

However, I can extract information related to the performance data provided to support the substantial equivalence claim.

Acceptance Criteria and Reported Device Performance

The document describes various performance tests conducted for the Tenax® Laser Resistant Endotracheal Tube to support its substantial equivalence. While specific numerical acceptance criteria are not explicitly detailed in this summary, the tests implicitly demonstrate that the device performs as intended and is safe and effective when compared to the predicate device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the provided test types):

Study Information (Based on available text):

1. Sample size used for the test set and the data provenance: Not explicitly stated for each test. The document mentions "The non-clinical test data support the safety of the device and the verification and validation testing data demonstrate that the Tenax® Laser Resistant Endotracheal Tube shall perform as intended in the specified use conditions." The nature of these tests (e.g., dimensional, mechanical, laser resistance) suggests laboratory-based testing on samples of the device. Data provenance (country of origin, retrospective/prospective) is not mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are non-clinical engineering and laboratory performance tests, not studies requiring expert interpretation of clinical data for ground truth.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. These are objective engineering and material performance tests.

4. 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 document describes a medical device (endotracheal tube), not an AI-powered diagnostic or assistive tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for an endotracheal tube, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the performance tests listed (e.g., dimensional, bend radius, cuff function, laser resistance), the "ground truth" would be established by validated engineering specifications, material standards, and physical measurements/observations during the tests. For biocompatibility, it's compliance with ISO 10993-1 standards and the results of the specific biological tests.

7. The sample size for the training set: Not applicable. There is no AI model or training set described in this document.

8. How the ground truth for the training set was established: Not applicable. No training set is described.

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The Venner Pneux ™ ETT (Endotracheal Tube) is intended to be used for patients undergoing tracheal intubation during routine anesthesia or over extended periods (not more than 30 days) and for the evacuation or drainage of secretion from the subglottic space.

The Venner PneuX ETT (Endotracheal Tube) is a disposable, sterile, single-patient, single-use device. It is a straight, flexible cuffed (low volume, low pressure) Nitinol wire-reinforced tracheal tube with a Murphy Eye. When a patient is intubated with a Venner PneuX ETT and inflated by standard techniques, it can be attached to the Venner PneuX TSM™M via the Venner PneuX™ Extension Tube, to monitor, maintain and regulate cuff pressure. The Venner Pneux TSM, a cuff pressure controller, was cleared for marketing via 510(k) application K110631 and the Venner PneuX Extension Tube is a class I, 510(k) exempt device.

The Venner PneuX ETT is available in four sizes (inner diameters: 6.0, 7.0, 8.0 and 9.0 mm) and is MRI compatible. Depth markings indicate the distal tip of the tube and a printed black line provides a means to orient the tube.

The device provides access to subglottic space by having three additional lumens running along the airway lumen. The three lumens are integrated into the tube wall ending just above the proximal end of the cuff for ease of suction. Connected to the suction tube and subglottic connector, it allows intermittent suctioning of secretions from the subglottic space, and irrigation.

A winged tube holder allows for securement with openings on each end for a head/neck strap to pass through. An integrated bite block with fixation block provides a protective covering and secures the position of the tube to preventunintended movement duringuse. A standard connector (15mm)for universal attachment to a ventilator or anesthesia equipment is present, as well as an inflation line to connect the cuff for inflation and deflation. A pilot balloon connects the cuff to provide an indication of the pressure within the cuff and the pilot valve opens to allow free flow of air to the cuff for inflation when a Luer lock syringe is engaged. When the syringe is removed, the valve closes to prevent leakage of air and ensures the cuff is inflated.

The provided text does not describe a study involving an AI/ML device, but rather a medical device, the Venner PneuX™ ETT (Endotracheal Tube). Therefore, the information requested in the prompt, such as acceptance criteria for AI algorithm performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable to the provided document.

The document focuses on demonstrating substantial equivalence of the Venner PneuX™ ETT to a predicate device (K093135) through performance testing, biocompatibility evaluation, and material/design comparisons.

Here's the relevant information about the device's acceptance criteria and study proving it meets them, based on the provided text:

Device: Venner PneuX™ ETT (Endotracheal Tube)

Acceptance Criteria and Reported Device Performance (based on this document, primarily focused on equivalence to predicate and relevant standards):

Regarding the non-applicable questions due to the nature of the device (not an AI/ML diagnostic system):

2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples of the medical device, not a data set for an AI algorithm. The document doesn't specify the number of units tested for each performance test, only that "samples" or "device" units were tested. Data provenance typically refers to the origin of data for AI/ML models (e.g., patient demographics, clinical sites), which is not relevant here.
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 an AI algorithm is not established for this type of conventional medical device. Performance is measured against engineering specifications and industry standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to expert consensus for labelling data for AI, which is not relevant here.
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 for AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. The "ground truth" for this device's performance is adherence to industry standards (e.g., ISO 5361, ISO 10993) and established engineering specifications.
8. The sample size for the training set: Not applicable. There is no AI training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a premarket notification for a conventional medical device, the Venner PneuX™ ETT, demonstrating its substantial equivalence to a predicate device by meeting various performance, material, and safety standards through physical testing, not through AI/ML model validation.

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The Salter Labs Trach-Vac endotracheal tubes are indicated for nasal or oral intubation of the trachea for anesthesia and airway management, including mechanical ventilation and suctioning of accumulated subglottic secretions in the trachea of adult patients.

The Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyurethane) and The Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyvinylchloride) are cuffed, sterile, single-use devices supplied with a standard 15mm conical connector. They are made primarily of polyvinylchloride with either a polyurethane (PU) or PVC cuff. In addition to the main lumen, the tube has a separate cuff inflation line and Evac lumen which has a dorsal opening above the cuff. A capped luer-style connection tube allows access to the separate lumen, enabling the health care professional to apply the suction to remove patient secretions. The tube incorporates a Magill curve, a hooded tip with two Murphy Eyes and a radiopaque line over the full length of the tube to assist in radiographic visualization.

The provided text describes a 510(k) premarket notification for a medical device, the Salter Labs Trach-Vac Endotracheal Tube. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this document.

However, I can extract information related to the device's technical specifications and how its performance was evaluated to demonstrate substantial equivalence for a non-AI/ML medical device.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the way an AI/ML study would define performance metrics and thresholds. Instead, it demonstrates performance by showing compliance with recognized standards and similarity to a predicate device. The "reported device performance" is essentially the device meeting these standards and exhibiting similar characteristics to the predicate.

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The Endotracheal Tube with Evacuation Lumen is intended for oral intubation and drainage of the subglottic space for airway management.

The Endotracheal Tube with Evacuation Lumen is sterile, single-use devices supplied with a standard 15mm connector. The Endotracheal Tube with Evacuation Lumen is a Magill curved construction with primary lumen for patient ventilation. Two (2) narrower lumens within the primary wall are used for cuff inflation and subglottic evacuation (vacuum). A low pressure, conformable cuff is inflated through the inflation tube with pilot balloon using a standard syringe (air only) through a non-return valve. For evacuation of subglottic secretions, a separate suction line, with a capped connector, connects to standard hospital vacuum receptacles. The tube incorporates a radiopaque line to assist in radiographic visualization. The Endotracheal Tube with Evacuation Lumen is PVC (polyvinylchloride) tube with a cylindrical-shaped cuff. The cuff is available with two materials PVC (polyvinylchloride) and PU(polyurethane). It is available in sizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 and 9.0mm and consists of tube, cuff, inflation tube, non-return valve, pilot balloon, 15mm connector, suction line.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Endotracheal Tube with Evacuation Lumen." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific clinical performance acceptance criteria in the way AI/ML devices might.

Therefore, the information typically requested in your prompt (e.g., acceptance criteria tables for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment methods) is not applicable to this document.

This FDA clearance is based on the device being substantially equivalent to a predicate device (K110269-Well Lead Endotracheal Tube with Evacuation Lumen), primarily by demonstrating that material modifications (changing PVC containing DEHP to DEHP-free PVC and PU) did not alter the intended use, fundamental scientific technology, or raise new safety and effectiveness issues.

Here's a breakdown of why your specific questions aren't addressed:

• Clinical Performance vs. Substantial Equivalence: This submission is about comparing a modified device to an existing one, not about establishing novel clinical performance metrics with an AI/ML algorithm.
• No AI/ML Component: The device is a physical medical device (an endotracheal tube), not an AI/ML software device. Therefore, there are no "algorithms," "training sets," "test sets," "expert readers," or "ground truth" to evaluate in the context of an AI's diagnostic or predictive performance.
• Focus on Bench Testing and Biocompatibility: The "study" mentioned for this device is non-clinical performance testing (bench testing) and biocompatibility testing to ensure the new materials and design maintain the same safety and performance characteristics as the predicate device.

However, I can extract information relevant to the device's validation and the comparison made for substantial equivalence:

Device Name: Endotracheal Tube with Evacuation Lumen

Predicate Device: K110269-Well Lead Endotracheal Tube with Evacuation Lumen

Reason for New Submission: The only modification made is to the materials of the cuff, main tube, inflation tube, suction line, and pilot balloon, changing from PVC containing DEHP to DEHP-free PVC and PU.

1. Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing):

The acceptance criteria here are implicitly that the modified device performs as well as the predicate device and meets established safety/performance standards for endotracheal tubes. The study involved a series of bench tests and biocompatibility tests.

• Suction Line O.D. & Length
• Tensile Force Test (Inflating tube and tracheal tube)
• Tensile Force Test (Suction tube and the connector of suction tube)
• Negative Pressure Resistance of Suction Line
  Conclusion: "Bench-top testing was conducted to assure conformance to... standards" and "The test results demonstrated that the device meets the performance requirements for its intended use." (Implies meeting or being equivalent to predicate device performance). |
  | Biocompatibility | Performed in accordance with ISO 10993-1.
  Specific tests:
• Cytotoxicity
• Sensitization
• Irritation/Intracutaneous reactivity
• Acute systemic toxicity
• Subchronic systemic toxicity
• Genotoxicity
• Material-mediate pyrogenicity
• Implantation
  Conclusion: "Biocompatibility testing provided in this submission demonstrate that the modified Endotracheal Tube with Evacuation Lumen is as safe and effective and performs as well as the predicate device." |
  | Sterilization | Validation of Ethylene Oxide sterilization.
  Conclusion: "Sterilization by ethylene oxide has been validated for Endotracheal Tube with Evacuation Lumen." |
  | Risk Analysis | Performed according to ISO 14971 - Medical Devices Application of risk management to medical devices, using "Failure Mode and Effect Analysis" technique.
  Conclusion: "No new issues of safety and effectiveness were identified during this process." |

The following information is not applicable to this 510(k) submission for a physical medical device. These questions are typically asked for AI/ML-driven diagnostic devices.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not data analysis for AI.
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): Not applicable. No "ground truth" in this AI/ML sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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