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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 Disposable Endobronchial Blocker Tube is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5Fr Endobronchial Blocked for infants populations; The 7Fr Endobronchial Blocker Tube is indicated for children populations; The 9Fr Endobronchial Blocker Tube is indicated for adults use only.

Patient Population: Patients requiring one lung isolation. Environment of Use: Hospitals-OR and ICU.

The Disposable Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. It is composed of blocker catheter, cuff, three-way connector, tube connector, one-way valve (with a pilot balloon) and multifunctional adaptor.

The blocker catheter has a flexible angled tip which can be easily placed into desired bronchus. It also contains a polyurethane cuff at its distal tip to create an effective seal within the inner bronchial wall and minimize potential trauma to the bronchus. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. This pilot balloon assembly facilitates inflation of the distal balloon and maintains inflation until it is released. The distance markings on the blocker catheter indicate how far the blocker has been advanced.

The multi-functional adaptor can be used by connecting a blocker tube to various endotracheal tubes and anesthetic circuits.

The Disposable Endobronchial Blocker Tube is available in three models: 5Fr, 7Fr and 9Fr. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only.

The provided text describes a 510(k) premarket notification for a Disposable Endobronchial Blocker Tube. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information typically requested in your prompt regarding artificial intelligence (AI) device performance, ground truth establishment, expert adjudication, multi-reader multi-case studies, and standalone algorithm performance is not applicable to this medical device submission.

The "study" described in the document is a series of non-clinical, functional and biocompatibility tests intended to show that the new device performs similarly and safely compared to the predicate device, not necessarily to prove a specific clinical efficacy or diagnostic accuracy.

Here's the breakdown of the information that is available based on your request, with an explanation for the parts that are not applicable:

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

The document states: "Testing datas and results are included in this submission, and demonstrated that the Disposable Endobronchial Blocker Tube meets all the pre-determined testing and acceptance criteria." However, the specific acceptance criteria and the detailed reported Device performance values are not explicitly listed in the provided text. The document lists the types of tests performed:

2. Sample sized 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 sample sizes used for the non-clinical tests (e.g., how many blocker tubes were tested for dimensions, cuff seal, etc.), nor does it mention data provenance as it's not a clinical study involving 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)

This is not applicable. The "ground truth" equivalent for a physical device like this is its compliance with engineering specifications and biocompatibility standards, not clinical diagnostic accuracy assessed by human experts.

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

This is not applicable. Adjudication methods are typically relevant for clinical studies or AI performance evaluations where human expert consensus is needed.

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

This is not applicable. The device is a physical medical instrument, not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI effect sizes are irrelevant to this submission. The submission explicitly states: "Clinical and animal testing were not performed for Disposable Endobronchial Blocker Tube as part of the premarket Notification requirements for this 510(k) submission and the subject of this premarket submission, Disposable Endobronchial Blocker Tube, did not require clinical and animal studies to support substantial equivalence."

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

This is not applicable, as it is not an AI algorithm.

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

The "ground truth" for this medical device's performance is adherence to established engineering specifications, performance standards (like ISO 5361:2016 for anesthetic and respiratory equipment), and biocompatibility guidelines (ISO 10993 series).

8. The sample size for the training set

This is not applicable. There is no AI model or "training set" for this physical device.

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

This is not applicable.

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The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD), in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console is capital equipment that is reusable and displays the patient information.

The Chartis Precision Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a standard video or fiber bronchoscope during a diagnostic bronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, the distal tip of the Chartis Precision Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Precision Catheter causes the airway to become sealed and isolated. Air can then flow out of the isolated lung compartment into the environment only through the central lumen of the Chartis Precision Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Precision Catheter lumen during spontaneous respiration or air flow during mechanical ventilation. The Chartis Precision Catheter is designed for use in conjunction with the Chartis Console. The Chartis Console is a previously cleared device (under K180011) and the subject 510(k) is solely for the Chartis Precision Catheter.

Here's a breakdown of the acceptance criteria and the study information for the Chartis Precision Catheter based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various non-clinical tests performed to demonstrate the safety and efficacy of the Chartis Precision Catheter. However, it does not explicitly list quantitative acceptance criteria or specific reported performance values in a single table as typically expected for device performance metrics like sensitivity, specificity, or accuracy.

Instead, the document states that "The Chartis Precision Catheter completed the following functional testing after being subjected to sterilization, conditioning and distribution" and that "The Chartis Precision Catheter successfully completed repeated functional testing..." and "Packaging validation testing..." and "Sterilization validation testing..." These statements imply that the device met predetermined, internally established acceptance criteria for each test. The "reported device performance" is essentially that the device passed these tests.

Below is a table summarizing the types of tests performed, which indirectly represent the areas where acceptance criteria were applied:

• Tensile testing of all fittings and joints of catheter, obturator, and connector set: Implies components can withstand specified tensile forces without failure.
• Airway resistance testing: Implies the catheter functions to allow measurement of airflow and pressure for resistance calculation as intended.
• Bronchoscope deflection angle testing: Implies the catheter does not impede bronchoscope movement beyond acceptable limits.
• Obturator removal force testing: Implies the obturator can be removed with an acceptable force.
• Torque transmission and kink testing: Implies the catheter can transmit torque effectively and resists kinking.
• Leak testing: Implies the system maintains integrity and prevents leaks during operation.
• Catheter insertion and withdrawal force testing: Implies the catheter can be inserted and withdrawn smoothly with acceptable force.
• Dimensional and visual inspection verifications: Implies the catheter meets specified dimensions and visual quality standards.
• Simulated use testing: Implies the device performs as intended in a simulated clinical environment. |
  | Shelf-life Testing | - Repeated functional testing: Implies the device maintains functional performance after accelerated aging.
• Pouch seal tensile strength testing: Implies the packaging maintains integrity over the specified shelf-life. |
  | Packaging Validation Testing | - Visual inspection, bubble leak testing, pouch seal tensile strength testing: Implies packaging integrity and sterile barrier are maintained after sterilization, conditioning, and distribution. |
  | Biocompatibility Testing | - Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity: Implies no unacceptable biological response to device components.
• Gas Pathway Testing (Particulate Matter, Volatile Organic Components, Toxicological Risk Assessment): Implies gas pathway is safe and free from harmful contaminants. |
  | Sterilization Validation | - Electron beam irradiation process at a sterility assurance level (SAL) of 10^-6: Implies the device achieves the required sterility level after sterilization. |

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

The document does not specify sample sizes for the individual non-clinical tests (e.g., how many catheters were used for tensile testing, or how many packages for shelf-life). It indicates that the tests conform to design controls (21 CFR §820.30) and relevant ASTM and ISO standards, which would dictate appropriate sample sizes for each test.

The data provenance is non-clinical bench and lab testing conducted by the manufacturer, Pulmonx Corporation, in Redwood City, California. It does not involve patient data (retrospective or prospective) in the way a clinical study would.

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

This question is not applicable to the provided information. The tests described are non-clinical, mechanical, and material-based. They do not involve expert interpretation or subjective evaluation that would require establishing "ground truth" by experts in a clinical sense. The ground truth for these tests is based on objective measurements against established engineering specifications and industry standards.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple experts evaluate ambiguous cases to reach a consensus. The tests performed here are objective performance tests with pass/fail criteria based on measured values.

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

This question is not applicable. The Chartis Precision Catheter is a medical device for measuring pressure and flow to quantify collateral ventilation, not an AI-powered diagnostic tool that assists human readers in interpreting images or data. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

This question is not applicable. The Chartis Precision Catheter is a physical medical device. While it works in conjunction with the Chartis Console (which processes data), the submission does not describe an "algorithm only" or "AI" component in the context of its performance evaluation. The device's performance is intrinsically linked to its physical interaction and measurements.

7. The Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" is based on established engineering specifications, industry standards (ASTM, ISO), and predefined performance metrics. For example:

• Functional Testing: Ground truth is defined by specified force limits, pressure ranges, dimensional tolerances, and successful operation during simulated use.
• Shelf-life Testing: Ground truth is the maintenance of functional performance and sterile barrier integrity over the specified shelf-life.
• Biocompatibility Testing: Ground truth is the absence of adverse biological reactions as per ISO 10993.
• Sterilization Validation: Ground truth is achieving a Sterility Assurance Level (SAL) of 10^-6.

8. The Sample Size for the Training Set

This question is not applicable. This device does not use machine learning or AI models that require a "training set" of data. The evaluation is based on traditional engineering and medical device testing principles.

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

This question is not applicable, as there is no training set for this device.

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

The Simple One Lung Ventilation for Everyone (sOLVe) Tube is a single use dual lumen endobronchial tube (DLT) intended for lung isolation and for lung ventilation by healthcare professionals (HCP) in hospitals. The sOLVe Tube can function as both a left-sided and a rightsided DLT. The distal tip of the tube will fit in either the left or right mainstem bronchus. The sOLVe Tube is packaged and provided to the HCP as a kit. The kit includes the following components: 1. sOLVe Tube with pre-installed pliable aluminum 10Fr intubation stylet 2. Dual Bronchoscopy Swivel adapter with integrated safety clamp 3. Haider TubeGuard endotracheal tube holder/bite block with strap 4. Soft suction catheters 5. Two syringes (3 mL and 10 mL)

The provided text is a 510(k) summary for the sOLVe Tube™, a medical device intended for lung isolation and ventilation. The document describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical testing. However, it does not contain specific acceptance criteria, reported device performance metrics against those criteria, details about sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, or results from MRMC or standalone studies.

Therefore, I cannot fully answer your request with the information provided. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench and animal testing, rather than reporting quantitative performance metrics against pre-defined acceptance criteria.

Based on the available information, here is what can be extracted and what is missing:

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

• Information Provided: The document lists several performance tests conducted (e.g., Determination of Cuff Diameter, Resistance to Cuff Tube Collapse, Cuff Compliance Leak Test, Bronchoscope Insertion Test, Ease of Insertion in animal model, Performance of tracheal/bronchial balloon, Success of lung isolation and one lung ventilation).
• Missing: Specific quantitative acceptance criteria for each of these tests are not provided. The document only states that "The results of these tests support the substantial equivalence of the sOLVe Tube to the predicate device," implying that the device met some internal or industry-standard criteria, but these criteria and the exact results are not detailed.

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

• Information Provided: The document mentions "Cadaver Trial to test the Universal Design" and "Performance Testing (Animal)."
• Missing: The specific sample sizes for these tests (e.g., number of cadavers, number of animals) are not provided. Data provenance (country of origin, retrospective/prospective) is also not provided.

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)

• Missing: This information is not provided as the studies appear to be primarily non-clinical (bench and animal testing). There is no mention of human experts establishing "ground truth" in the context of diagnostic performance.

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

• Missing: This information is not provided as it relates to expert review of data, which is not described for the non-clinical tests.

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

• Missing: This is inapplicable. The described device is an endobronchial tube, not an AI software/diagnostic tool that would involve human "readers" or an "AI assistance" component.

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

• Missing: This is inapplicable. The described device is an endobronchial tube, not an algorithm.

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

• Information Provided: For bench tests, the "ground truth" would be the direct measurement against the test standard (e.g., ISO specifications). For animal trials, it would be direct observation of "Ease of Insertion," "Performance of the Tracheal and Bronchial Balloon," and "Success of Lung Isolation and One Lung Ventilation."
• Missing: Specific details on how success was quantified or measured consistently are not provided.

8. The sample size for the training set

• Missing: Not applicable. The device is a physical medical device, not a machine learning model that requires a training set.

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

• Missing: Not applicable for the same reason as above.

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Intubation with Ambu VivaSight 2 DLT is indicated for pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation of one lung from the other, e.g. for thoracic surgery.

Ambu VivaSight 2 DLT is a sterile, single-use, double-lumen endobronchial tube intended to be used for isolation of the left or right lung of a patient for one lung ventilation.

The VivaSight 2 DLT system is intended to be used for verifying tube placement and repositioning.

Intubation with VivaSight 2 DLT 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.

Ambu VivaSight 2 DLT is a sterile, single-use, left-sided, double-lumen endobronchial tube with an embedded video camera and light source at the distal end of the tracheal lumen and integrated video cable with video connector.

The embedded video camera is used for visualization during the intubation procedure and to verify the tube placement. The picture is shown on an Ambu displaying unit, which Ambu VivaSight 2 DLT is connected to via Ambu VivaSight 2 Adapter Cable. Ambu VivaSight 2 Adapter Cable is a non-sterile, single patient use accessory to Ambu VivaSight 2 DLT. Ambu VivaSight 2 DLT is connected to and powered by an Ambu displaying unit via Ambu VivaSight 2 Adapter Cable; the whole system is referred to as the VivaSight 2 DLT system.

Ambu VivaSight 2 DLT is indicated for left or right lung isolation and use as a temporary artificial airway in adults requiring mechanical one-lung ventilation and is fitted with a stylet to enable shaping of the tube for navigation during intubation.

A colorless tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, a blue bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation.

A flush line with flush exits next to the camera lens ensures possibility for cleaning of the camera lens.

Ambu VivaSight 2 DLT can be connected to ventilation equipment via a Y-connector, which is included with the product. The Y-connector is sterile, single-use. The Y-connector caps enable lung deflation and use of accessories such as bronchoscopes and suction catheters in Ambu VivaSight 2 DLT. Furthermore, valves on the Y-connector enables opening and closing of the ventilation flow to each of the tracheal and bronchial lumens. The Y-connector airway tubes are colour coded to indicate tracheal and bronchial connection.
Ambu VivaSight 2 DLT will be available in four sizes: 35 Fr, 37 Fr, 39 Fr, and 41 Fr.

The provided text is a 510(k) summary for the Ambu VivaSight 2 DLT. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study with human-in-the-loop or standalone AI performance.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document because the submission relies primarily on bench testing and compliance with recognized consensus standards to show substantial equivalence.

The document explicitly states: "The following data have been submitted in the premarket notification to support safety and effectiveness of the device: Testing - Bench Declaration of conformity to the following applicable recognized consensus standards..."

It then lists various bench tests and standards with "Result: All tests passed." and concludes: "Performance testing has demonstrated that the device is as safe and effective as the predicate device."

The acceptance criteria and study detailed in your request (focused on AI performance, human reader improvement, and specified ground truth methodologies) are not applicable to the information provided in this 510(k) summary for the Ambu VivaSight 2 DLT.

This device is a medical instrument (double-lumen endobronchial tube with an embedded camera), not an AI-driven diagnostic or assistive technology in the context of the detailed questions. The "visualization during the intubation procedure" refers to a live video feed for direct human observation, not an image analysis AI that would require the kind of performance studies you've outlined.

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

ANKOR Endobronchial tube is consisted with double lumen tube with the body including 3 cuff (Bronchus Cuff, Trachea Cuff and ANKOR Cuff) / 2 cuff (Bronchus Cuff and Trachea Cuff), the stylet and elbow connector in order to separate connector for isolating and ventilating one lung during surgical procedures. The different point, between ABC Model and HBC Model, is whether ANKOR Cuff is consisted. ANKOR Cuff, which is a part of the ABC Model only, takes to check correct insertion of the catheter. When user is lack of the experience or is not confidence with operation, ABC Model is intended to use. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 10Fr or 12Fr with PVC (Listing Number: D422226) and this device is packaged with these suction catheter (Listing Number: D422226). The device is made of silicone as a main material and is available in 33Fr to 39Fr depending on the patients who is requiring one-lung isolation under OR and ICU including Non-MR Environment only.

The provided text describes the 510(k) summary for the ANKOR Endobronchial Tube, which is a medical device for tracheal/bronchial differential ventilation. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific acceptance criteria for AI performance. As such, the document does not contain information related to AI or a study that proves a device meets acceptance criteria for an AI-powered system.

Therefore, I cannot provide the requested information about acceptance criteria and study data for an AI-powered device based on the provided text. The document focuses on performance testing of the physical medical device and its biocompatibility, sterilization, and material properties, rather than AI performance.

Specifically, the document explicitly states in Section 8:

"Clinical and animal testing were not performed for ANKOR Endobronchial Tube as part of the premarket notification requirements for this 510(k) submission and the subject of this premarket submission, ANKOR Endobronchial Tube, did not require clinical and animal studies to support substantial equivalence."

This reinforces that the approval is for a traditional medical device, not an AI-enabled one, and thus the specific metrics and study designs requested for AI performance are not relevant to this submission.

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The ETView VivaSight-DL is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia. The VivaSight-DL System is indicated for verifying tube placement and repositioning.

The ETView VivaSight-DLTM System functions as a standard endobronchial tube that additionally has an embedded video imaging device in its tracheal lumen. The system provides a video image of the patient's bronchus, which is displayed on the monitor, for as long as the VivaSight-DL™ is inside the patient's bronchus. Visualization of the bronchus is used to verify placement and repositioning of the endobronchial tube during the intubation procedure or throughout surgery.

This FDA 510(k) summary for the VivaSight-DL System focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information regarding AI device acceptance criteria, study design, and performance cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific performance criterion (e.g., accuracy, sensitivity, specificity) for the device's diagnostic or assistive capabilities (like verifying tube placement) are provided in a quantitative manner. The document asserts that the device "met its specifications" and performed "substantially equivalent" to the predicate, but it does not detail those specifications or present performance data against them.

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

Not applicable. This document describes performance testing primarily through bench tests and engineering evaluations, not a clinical test set with patient data.

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

Not applicable. No clinical ground truth establishment is described for a test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

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

No. An MRMC study is not mentioned. The document primarily focuses on demonstrating substantial equivalence through technical comparisons and bench testing.

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

No standalone performance of an AI algorithm is described. The device, a video-enabled endotracheal tube, provides visual information to a human user for verification of tube placement.

7. Type of Ground Truth Used

The ground truth for the device's function (providing a video image for placement verification) implicitly relies on established medical practice for observing and confirming tube placement. However, for the performance testing described in the document, the "ground truth" was likely derived from engineering specifications, successful completion of bench tests (e.g., video signal clarity, mechanical integrity), and compliance with standards.

8. Sample Size for the Training Set

Not applicable. This device is not described as an AI/ML device that requires a training set.

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

Not applicable.

Summary of Relevant Information from the Document:

While the document doesn't provide the requested AI-specific details, it does state the following regarding device performance and testing:

• Acceptance Criteria (Implied / Indirectly stated):

  • Compliance with various international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 10993-1, ISO 14971, ISO 5361, ISO 16628, ISO 11135).
  • Functional equivalence to the predicate device (K123853).
  • Satisfactory results from bench tests to demonstrate compatibility of the new adapter with the Ambu aView monitor (including Video signal test, time restriction test, electronics test, image quality, IP rating, and mechanical test).
  • Biocompatibility in accordance with ISO 10993-1.

• Study Proving Acceptance Criteria:

  • Type of Study: Performance testing, primarily non-clinical laboratory performance testing and bench tests.
  • Details:
    • Non-clinical, laboratory performance testing performed according to ISO 5361 and ISO 16628.
    • Electrical safety and EMC testing for the new cable adapter.
    • Bench tests for compatibility with the Ambu aView monitor, including:
      • Video signal test
      • Time restriction test
      • Electronics test
      • Image quality
      • IP rating
      • Mechanical test
    • Biocompatibility testing (for materials in contact with the human body, found to be identical to the predicate and compliant with ISO 10993-1).

• Device Performance (as reported): The performance testing "demonstrated that the ETView VivaSight-DLTM is substantially equivalent to the cleared predicate device." The new cable adapter and its integration were also demonstrated to be substantially equivalent.

This 510(k) submission focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a novel AI algorithm's performance. The "acceptance criteria" are therefore framed around meeting established standards and demonstrating technical and functional similarity to the predicate, with bench testing as the primary method of proof.

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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 5.0 Fr Arndt Endobronchial Blocker Set is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5.0 Fr Arndt Endobronchial Blocker is indicated for pediatric populations, in children 1 year and older.

The 9.0 Fr Arndt Endobronchial Blocker Set is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 9.0 Fr Arndt Endobronchial Blocker is indicated for adult use only.

The 5.0 Fr Arndt Endobronchial Blocker Set and the 9.0 Fr Arndt Endobronchial Blocker Set are comprised of a blocker catheter with a silicone balloon near the distal end. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. A nylon guide loop at the distal end of the blocker catheter is wrapped around the tip of the bronchoscope and tightened, in order for the bronchoscope to assist in the precise placement of the blocker catheter. An Arndt Multiport Airway Adapter, a proximal straight connector, a suction adapter, and a syringe are also provided with each set.

This document describes the premarket notification for the 5.0 Fr Arndt Endobronchial Blocker Set and the 9.0 Fr Arndt Endobronchial Blocker Set. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study where the device proves it meets acceptance criteria through clinical performance metrics like sensitivity, specificity, etc.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics such as accuracy, sensitivity, specificity, and related study designs (e.g., sample sizes for test/training sets, expert consensus, MRMC studies), cannot be extracted directly from this document. This is a 510(k) submission, which primarily relies on technological characteristics and comparison to legally marketed predicate devices to establish substantial equivalence. Clinical performance studies with human readers or standalone algorithm performance are typically not required for this type of submission unless new questions of safety or effectiveness are raised.

The document does, however, detail various engineering and performance tests conducted to ensure reliable design and functionality of the device itself, rather than its clinical performance in diagnosing or assisting human experts.

Here's an attempt to address your points based on the available information, noting the limitations:

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

The document provides a list of engineering and performance tests with their general acceptance criteria and outcomes. The performance is reported as meeting "established acceptance criteria." Quantitative results are not provided beyond "greater than or equal to" or "do not exhibit signs of leakage or burst."

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

This document describes device engineering and performance testing (e.g., tensile strength, balloon inflation) on the device itself, not a clinical study involving patients or human data for clinical performance evaluation. Therefore, "test set" in the context of clinical data or patient data is not applicable here. The "test articles" in the engineering tests refer to physical units of the device. The sample sizes for these engineering tests are not specified in the provided text. Data provenance (country of origin, retrospective/prospective) is also not applicable as it's not a clinical study using 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. This is not a study requiring expert interpretation or ground truth establishment of clinical findings. The "ground truth" for the engineering tests would be established by validated test methods and physical property standards.

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

Not applicable. This is not a study requiring adjudication of clinical findings.

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 a study involving human readers or AI assistance.

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

Not applicable. This is a medical device (a physical blocker set), not an algorithm or AI system.

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

For the engineering tests described, the "ground truth" would be the established physical and material properties, and the performance expectations defined by the device's design requirements. These are validated through standard engineering and materials testing methodologies.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI study that requires a training set.

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

Not applicable.

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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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