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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 aeris Balloon Dilation Catheter is intended for use in adult and pediations to dilate strictures of the airway.

The aeris Balloon Dilation Catheter is comprised of a sinqle lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A luer lock at the proximal end is used for placement of the stylet and injecting sterile water into the balloon. Two radiopaque markers, located on the catheter, inside the balloon, can be used to confirm balloon placement under Fluoroscopy.

The aeris Balloon Dilation Catheter includes inflation balloons of diameters 5, 7, 8, 9, 10, 12, 14, and 16 mm with complementing characteristics as shown in Table 1.

The provided text describes the acceptance criteria and the results of various bench tests for the aeris Balloon Dilation Catheter as part of a 510(k) submission for substantial equivalence. It does not include information about a study involving human readers, AI, or specific details on studies for ground truth establishment for a test set. This is a technical device submission, not an AI/algorithm-based diagnostic device.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides multiple tables summarizing the bench testing results for different sizes of the aeris Balloon Dilation Catheter and a comparison with predicate devices. For conciseness, a combined table of the types of tests and their general acceptance criteria and performance will be presented, referencing the detailed tables for specific values.

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