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The Disposable Double Lumen Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery.

The Disposable Double Lumen Endobronchial Tube is indicated for adults use only.

The Disposable Double Lumen Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung.

The Disposable Double Lumen Endobronchial Tube is consisted with double lumen tube with the body including 2 cuffs (Bronchial Cuff and Tracheal Cuff).

The tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, the bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. It is fitted with a stylet to enable shaping of the tube for navigation during intubation. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 8Fr or 10Fr with PVC and this device is packaged with two suction catheters.

The Disposable Double Lumen Endobronchial Tube comes in three models, each model include two types: Ordinary Left Type, Ordinary Right Type, Visible Left Type B, Visible Right Type B, Visible Left Type, Visible Right Type. Each type will be available in six sizes: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr and 41 Fr.

The device is composed of biologically safe materials. It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery. The Disposable Double Lumen Endobronchial Tube is indicated for adults use only. Environments of use: Hospital-OR and ICU.

The provided text is a 510(k) summary for a medical device (Disposable Double Lumen Endobronchial Tube) and focuses on non-clinical performance testing and biocompatibility. It does not describe a study involving an AI algorithm or human readers.

Therefore, many of the requested details about acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for training set, effect size of AI assistance) are not applicable to this document.

The document primarily describes non-clinical performance testing to demonstrate functional and material equivalence to a predicate device.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance (Non-Clinical)

The submission provides a table of non-clinical performance test items, their reference standards, acceptance criteria, and reported test results.

1. Table of Acceptance Criteria and Reported Device Performance:

Biocompatibility Testing:

The biocompatibility evaluation was conducted based on the device's classification as a surface device in contact with mucosal membrane for limited exposure (

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The SHERIDAN® Endobronchial Tube is intenced for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The SHERIDAN® Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

The Sheridan Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung.

I am sorry, but based on the provided text, I cannot provide the requested information. The text describes a 510(k) premarket notification for a medical device (Sheridan Endobronchial Tubes) and focuses on demonstrating substantial equivalence to a predicate device.

The document does not contain information about:

1. A table of acceptance criteria and reported device performance for a study. Instead, it lists general tests performed (e.g., 15mm machine end Connector separation strength, Cuff resting diameter, Cuff herniation, Cuff Burst Evaluation, Cuff Bond Strength, Side arm bonding strength) and their principles, but no specific acceptance criteria or quantitative performance results are provided.
2. Sample size used for a test set.
3. Data provenance (country of origin, retrospective/prospective).
4. Number of experts or their qualifications for establishing ground truth.
5. Adjudication method.
6. Multi-reader multi-case (MRMC) comparative effectiveness study.
7. Standalone (algorithm-only) performance. The device described is a physical medical device, not an AI algorithm.
8. Type of ground truth used.
9. Sample size for a training set. Once again, this is a physical device, and the concept of a "training set" for an AI algorithm does not apply.
10. How the ground truth for the training set was established.

The document primarily focuses on comparing the proposed device's features, intended use, technology, and materials to a predicate device to establish substantial equivalence under the FDA's 510(k) pathway. It mentions "Non-clinical Comparative Performance Testing" but only lists types of tests, not the results or acceptance criteria that would allow for the detailed answers requested.

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The Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

The Endobronchial Tube is made of Polyvinylchloride and is available in sizes 26fr to 41fr. They are designated as double lumen tube with 2 cuffs and separate 15mm connectors for isolating and ventilating one lung during surgical procedures. The tubes contain an x-ray opaque line that runs through the tube making them detectable by x-ray. Environments of use: Hospital-OR and ICU

The provided text describes the 510(k) submission for the "Endobronchial Tube" by Henan Tuoren Medical Device Co., Ltd. and its substantial equivalence to a predicate device (Well LEAD Endobronchial Tubes, K092886). The evaluation primarily relies on non-clinical testing (bench testing and biocompatibility assessments) to demonstrate that the proposed device meets established standards and performs comparably to the predicate.

Here's an analysis of the requested information based on the provided text:

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

The document provides a detailed table of performance testing for the Endobronchial Tube.

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

The document does not specify the exact sample size for the mechanical performance tests, biocompatibility tests, or endotoxin tests. It mentions "non-clinical testing was performed" and provides "Test result" for each criterion. The data provenance is not explicitly stated in terms of country of origin for the testing, but the manufacturer is Henan Tuoren Medical Device Co., Ltd, China. The testing described is clearly prospective for the device being submitted, as it was performed to demonstrate compliance with standards.

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 product is a medical device (Endobronchial Tube, Class II), not an AI or imaging diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or clinical diagnosis is not applicable here. The "ground truth" for this device's performance is established by adherence to engineering and biocompatibility standards and quantified through objective physical and chemical measurements.

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

Not applicable. This is not a study involving human interpretation or subjective adjudication. The tests involve objective measurements against predefined criteria in recognized standards (e.g., ISO).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI diagnostic device. No MRMC study was performed or required.

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

Not applicable. This is not an algorithm or AI device. The performance is assessed based on the physical properties and biological compatibility of the device itself.

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

The "ground truth" for this device's performance assessment is primarily defined by:

• Engineering Standards: Specific requirements and limits outlined in international standards like ISO 5361, ISO 594/1, ISO 8836, and ISO 5356-1.
• Biocompatibility Standards: Criteria for no toxicity, sensitization, or irritation as per ISO 10993 series.
• Safety Standards: Endotoxin limits as per USP.

These standards provide objective, measurable criteria which serve as the ground truth against which the device's performance is evaluated.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in the context of data for an algorithm.

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

Not applicable. As there is no training set, there is no ground truth established for it. The standards mentioned in point 7 serve as the universally accepted benchmarks for this type of device.

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Rusch Endobronchial Tubes are used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

Patient Population: Patients requiring one lung isolation

Environment of use: Hospitals - OR and ICU

The Rusch Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung. The Endobronchial tube is sold with or without accessories, contains a stylet and is available in Robertshaw, Carlens and White styles.

The provided text describes a 510(k) premarket notification for the "Rusch Endobronchial Tubes." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical acceptance criteria through a comparative effectiveness study or AI-related metrics.

Therefore, many of the requested categories in your prompt are not applicable to this document. This submission does not involve AI, machine learning, or complex diagnostic performance evaluation against an established ground truth in the way your prompt implies.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted to demonstrate substantial equivalence to predicate devices, focusing on physical and mechanical properties. It doesn't present "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic algorithm, nor does it provide specific numerical "reported device performance" against those criteria. Instead, it describes the principle of the test to ensure the device functions as intended and is safe.

| Test | Principle of Test | Acceptance Criteria (Implied) | Reported Device Performance |
|-------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Connector bonding strength | The security of the attachment of the connector to the Endobronchial tube is tested by applying an axial separation force to the connector | Must meet specified force without separation (per ISO 5356) | Meets requirements for safe and effective use. |
| Cuff resting diameter | The resting diameter of the cuff is measured when the cuff is inflated to a reference pressure which is intended to remove creases but minimize stretching of its walls | Must fall within acceptable diameter range (per ISO 5361) | Meets requirements for safe and effective use. |
| Tube collapse | The patency of the Endobronchial tube airway lumen is tested by passing a steel ball through the Endobronchial tube lumen with the cuff inflated within a transparent tube | Steel ball must pass without obstruction (per ISO 5361) | Meets requirements for safe and effective use. |
| Cuff herniation | The tendency of the cuff to herniate beyond the plane perpendicular to the long axis of the tube at the nearest edge of the bevel is tested by applying an axial force with the cuff inflated within a transparent tube. A cuff which protrudes excessively at its patient end may partially or completely occlude the orifice at the patient end | Cuff protrusion must be within acceptable limits to prevent occlusion (per ISO 5361) | Meets requirements for safe and effective use. |
| Cuff Burst Evaluation | The cuff restrained burst test is designed to ensure the cuff will not burst or rupture when inflated inside the trachea | Cuff must not burst or rupture under specified inflation pressure inside the trachea. | Meets requirements for safe and effective use. |
| Cuff Bond Strength | To evaluate the strength needed to separate the cuff from the tube | Cuff must remain bonded to the tube under specified force. | Meets requirements for safe and effective use. |
| Side arm bonding strength | To evaluate the retention force of the inflation line connection to the Endobronchial tube | Inflation line connection must be retained under specified force. | Meets requirements for safe and effective use. |

Note: The phrase "Meets requirements for safe and effective use" is an interpretation based on the "Substantial Equivalence Conclusion" stating that "Performance test results demonstrate that the proposed device meets its intended use." Specific numerical results for each test are not provided in this summary.

The following sections are NOT applicable to the provided document, as it pertains to a traditional medical device (endobronchial tube) and not an AI/ML powered device or diagnostic tool.

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  • Not applicable. Physical device testing typically involves a set number of manufactured units, not a "test set" of patient data.
• 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. "Ground truth" in the context of diagnostic interpretation by experts is not relevant here.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • Not applicable. No expert adjudication process is described for this type of device.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
  • Not applicable. This is explicitly for AI-assisted diagnostic studies, which this is not.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • Not applicable. There is no algorithm here.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
  • Not applicable. For mechanical testing, the "ground truth" is typically the physical measurement against a standard or specification.
• 8. The sample size for the training set
  • Not applicable. There is no "training set" for this type of device.
• 9. How the ground truth for the training set was established
  • Not applicable. There is no "training set" or corresponding ground truth.

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The Well Lead Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

The Well Lead Endobronchial Tube is made of Polyvinylchloride and is available in sizes 28fr to 41fr. They are designated as double lumen tube with 2 cuffs and separate 15mm connectors for isolating and ventilating one lung during surgical procedures. The tubes contain an x-ray opaque line that runs through the tube making them detectable by x-ray.

The document provided is a 510(k) summary for the Well LEAD Endobronchial Tubes. It highlights the substantial equivalence of the device to previously cleared devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria through clinical performance.

Based on the provided text, here's what can be extracted and what is not available:

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

The document states: "All testing that is required by the required standards has been performed. None clinical testing was performed and included standards such as ISO 5361, ISO 16628 and ISO 10993-1. The Well Lead Medical Instruments Endobronchial Tubes have been found to fall within the required limits of the testing."

This indicates that the acceptance criteria are defined by the required limits set forth in the referenced ISO standards. However, the specific quantitative acceptance criteria (e.g., maximum leak rate, specific material strength values) and the exact performance metrics achieved are not provided in the summary. The summary only gives a general statement that the device met these "required limits."

Therefore, a table with specific acceptance criteria and reported device performance cannot be fully constructed from the provided text.

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

The document explicitly states: "None clinical testing was performed."

• Sample size for test set: Not applicable, as no clinical testing was performed.
• Data provenance: Not applicable, as no clinical testing was performed.

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, as no clinical testing with ground truth establishment was performed. The evaluation relied on non-clinical performance and biocompatibility testing against established standards.

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

Not applicable, as no clinical testing requiring adjudication was performed.

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 an endobronchial tube, not an AI-assisted diagnostic device, and no MRMC study was mentioned or required.

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

Not applicable. This is a medical device, not an algorithm, and the evaluation was based on non-clinical performance.

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

Not applicable, as no clinical studies requiring ground truth were performed. The "ground truth" for non-clinical testing would be the defined acceptable ranges and properties within the referenced ISO standards.

8. The sample size for the training set:

Not applicable, as no machine learning or AI component is described.

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

Not applicable, as no machine learning or AI component is described.

Summary of what can be inferred about acceptance criteria and "study" from the provided text:

The "study" that proves the device meets acceptance criteria consists of non-clinical performance testing and biocompatibility testing against recognized international standards.

• Acceptance Criteria Source: ISO 5361 (Anesthetic and respiratory equipment - Tracheal tubes and connectors), ISO 16628 (Tracheal tubes and other connection devices - Cuffs - Test methods for resistance to pressure and deflation), and ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).
• Device Performance: The Well Lead Medical Instruments Endobronchial Tubes were found to "fall within the required limits of the testing." This is a qualitative statement indicating compliance.
• Type of Study: Non-clinical (bench testing) and biocompatibility testing.
• Clinical Data: Explicitly stated as "None clinical testing was performed."
• Basis for Equivalence: Substantial equivalence was claimed based on equivalent intended use, manufacturing materials, operating principles, and physical operational specifications compared to predicate devices (K771219 - Mallinckrodt Bronch-Cath and K051522 - Fuji Double Lumen Bron Tube).

In essence, for this specific device, the FDA cleared it based on demonstrating adherence to established non-clinical performance standards and substantial equivalence to existing devices, without requiring human clinical trials or AI-related performance studies.

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