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The ETView VivaSight-SL (TVT) is intended for intubation procedures. The ETView VivaSight-SL (TVTM) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral intubations.

The VivaSight-SL (TVT) System is indicated for viewing during non-difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing and for general inspection of the airway.

The ETView VivaSight-SL (TVT™) is a single use, cuffed device that functions as a standard endotracheal tube (ETT) and additionally has an embedded video imaging device embedded in a dedicated lumen. The system provides a video image of the patient's trachea, which is displayed on the monitor, for as long as the VivaSight-SL (TVT™) is inside the patient's trachea.

The provided text describes a medical device, the ETView VivaSight-SL (TVT) system, and its substantial equivalence to a predicate device, but it does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or the detailed aspects of such a study as requested in your prompt.

The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria in the way you've outlined.

Based on the provided text, I can extract the following limited information:

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

The document mentions compliance with several standards but does not provide a table of specific acceptance criteria for performance metrics or reported device performance in quantitative terms. Instead, it states that "Performance testing demonstrated that the ETView VivaSight-SL (TVT™) is substantially equivalent to the cleared predicate device."

2. Sample sized used for the test set and the data provenance:

Not specified. The document refers to "performance testing" and "bench tests" but does not give sample sizes or details on data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as a study with expert-established ground truth is not described.

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. The device is a video-enabled endotracheal tube, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. The device is a physical medical instrument with an embedded video imaging device.

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

Not applicable. The performance testing mentioned primarily relates to compliance with engineering and safety standards (ISO, IEC).

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device requiring a training set.

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

Not applicable.

Summary of available information related to performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ETView VivaSight-SL K121028) by comparing "Technological Characteristics" and stating compliance with recognized performance and safety standards.

• Performance Standards Mentioned:

  • ISO 5361 Anesthetic and respiratory equipment -- Tracheal tubes and connectors
  • ISO 11135 Sterilization of health care products Ethylene oxide
  • ISO 14971-1 Risk management for medical devices
  • ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing
  • IEC 60601-1 Medical Electrical Equipment, General Requirements for Safety
  • IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety, Collateral Standard: Electromagnetic Compatibility
  • IEC 60601-2-18 Medical Electrical Equipment Part 2-18: Particular requirements for the safety of endoscopic equipment

• Performance Testing Done:

  • "ETView performed a set of performance test according to ISO5361 requirements." These tests "demonstrated that the ETView VivaSight-SL (TVT™) is substantially equivalent to the cleared predicate device."
  • "The addition of the new adapter for connection to Ambu aView Monitor was tested through electrical safety and EMC testing" to ensure it "does not raise different questions of safety or effectiveness."
  • "Bench tests were conducted in order to demonstrate the compatibility of the proposed adapter and Ambu aView monitor with the ETView VivaSight-SL (TVT™)." These tests included: Video signal test, time restriction test, electronics test, image quality, IP rating, and mechanical test.

• Biocompatibility:

  • "Materials of the ETView VivaSight-SL (TVT™) system that are in contact with the human body, are identical to the predicate (K121028) and were tested and found to be biocompatible in accordance with ISO 10993-1."

The document concludes that the device is substantially equivalent to its predicate without raising different questions of safety and/or effectiveness based on this testing. Specific quantitative acceptance criteria or detailed study results are not provided in this 510(k) summary.

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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 ETView VivaSight-SL (TVT) is intended for intubation procedures. The ETView VivaSight-SL (TVT™) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.

The VivaSight-SL (TVT™) System is indicated for viewing during non-difficult and difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing during suctioning and for general inspection of the airway. VivaSight-SL (TVT™) System is compatible for use with standard Laryngeal Mask Airway (LMA).

The ETView VivaSight-SL (TVT™) is a single use, cuffed device that functions as a standard endotracheal tube (ETT) and additionally has an embedded video imaging device embedded in a dedicated lumen. The system provides a video image of the patient's trachea, which is displayed on the monitor, for as long as the VivaSight-SL (TVTM) is inside the patient's trachea.

This document K152438, a 510(k) premarket notification for the ETView VivaSight-SL System (TVT™), describes the device's substantial equivalence to predicate devices rather than providing a standalone study with detailed acceptance criteria and performance metrics. Therefore, a complete table of acceptance criteria and reported device performance, and several other requested details cannot be extracted. However, based on the provided text, the following information can be inferred or explicitly stated:

Table of Acceptance Criteria and Reported Device Performance

Here's the additional information, based on the provided text:

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

• The document states, "Performance tests were conducted on ETView VivaSight-SL (TVT™)'s predicate (K121028) and provided in that submission. The two devices are identical; therefore the tests are applicable to both devices."
• For the specific performance test demonstrating LMA compatibility: The document only mentions "inspections" as part of the test. It does not explicitly state a numerical sample size (e.g., number of devices, number of trials, or number of patients/simulations).
• Data Provenance: The document does not specify the country of origin for the test data for either the predicate device (K121028) or the LMA compatibility test. It also does not explicitly state if the tests were retrospective or prospective, though device performance testing is typically prospective.

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

• This information is not provided in the document. The performance tests described (LMA compatibility, physical/functional, electrical, etc.) are primarily engineering and bench testing, not clinical studies requiring expert ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

• This information is not provided as the tests described are engineering/bench tests and not clinical studies involving human assessment that would require an adjudication method.

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, an MRMC comparative effectiveness study was not done. The device (ETView VivaSight-SL System) is an endotracheal tube with an embedded video imaging device, not an AI or diagnostic imaging interpretation system. Its function is to provide direct visualization during intubation and for airway inspection/verification, not to assist human readers in interpreting medical images.

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

• No, this is not applicable. The device is a physical medical instrument (an endotracheal tube with a camera), not an algorithm. Its "performance" is inherently tied to its physical and functional characteristics and its use by a clinician ("human-in-the-loop").

7. The Type of Ground Truth Used:

• For the LMA compatibility test and other physical/functional tests, the "ground truth" was based on engineering specifications, direct observation/inspection during testing, and compliance with recognized standards (e.g., ISO, IEC). It was not based on expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic device.

8. The Sample Size for the Training Set:

• Not applicable/Not provided. This device is a hardware product and does not involve a "training set" in the context of machine learning or AI models. Its design and performance are based on engineering principles and testing against established standards.

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

• Not applicable. As explained in point 8, there is no "training set" for this type of medical device. Its performance is demonstrated through testing against predefined engineering and biocompatibility standards.

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The ETView VivaSight-DLTM System 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-DLTM 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.

The provided text is a 510(k) summary for the VivaSight-DL™ System, a medical device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. The "Performance Testing" section outlines various tests conducted to demonstrate safety and effectiveness.

Here’s an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or specific performance values against those criteria for each test. Instead, it states that "Performance tests were performed in order to demonstrate that the new tube dimension of the VivaSight-DLTM is as safe and effective as the market-cleared ETView DLVT™ system."

It concludes that "The results of the performance tests clearly demonstrate that the ETView VivaSight-DLTM device is as safe and effective as its predicate without raising any new safety and/or effectiveness concerns." This implies that the device met all unstated acceptance criteria for each test by demonstrating equivalence to the predicate.

The tests conducted are listed as:

• Determination of Cuff Resting Diameter
• Cuff Leak Resistance Integrity
• Cuff Symmetry
• Resistance to tube collapse
• Determination of effective inside diameter
• Determination of the bronchial segment
• Resistance to cuff herniation
• Air flow resistance
• Thermal safety
• Tracheal seal

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

The document does not specify the sample size used for the performance tests. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for these tests. All tests appear to be laboratory or bench tests, not involving direct patient data.

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

Since the performance tests are physical/mechanical tests of the device's characteristics (e.g., cuff diameter, leak resistance), there is no mention of "experts" in the context of establishing ground truth in the way one would for clinical diagnostic studies. The ground truth for these tests would inherently be the measured physical properties of the device components.

4. Adjudication Method for the Test Set

Not applicable. The performance tests are objective measurements of physical properties, not subjective assessments requiring adjudication by experts.

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

No, an MRMC comparative effectiveness study was not done. The testing focused on the physical characteristics and performance of the device itself, not on human reader interpretation or the impact of the device on human reader performance.

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

This device is not an algorithm or AI system. It is a physical medical device (an endobronchial tube with an embedded camera). Therefore, the concept of "standalone algorithm performance" is not applicable. The device's "standalone" performance is assessed through the physical performance tests mentioned.

7. The Type of Ground Truth Used

The ground truth for the performance tests was based on objective physical measurements of the device's properties (e.g., diameters, resistance, symmetry) against established standards and equivalence to a predicate device.

8. The Sample Size for the Training Set

This device is a physical medical device, not an AI or machine learning system that requires a "training set." Therefore, this question is not applicable.

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

Not applicable, as there is no training set for this type of device.

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The ETView Tracheoscopic Ventilation Tube (TVTM) is intended for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVTM) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.

The TVT" System is indicated for viewing during non-difficult and difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing during suctioning and for general inspection of the airway.

The ETView Tracheoscopic Ventilation Tube (TVT™) is a single use, cuffed device that functions as a standard endotracheal tube (ETT) and additionally has an embedded video imaging device embedded in a dedicated lumen. The system provides a video image of the patient's trachea, which is displayed on the monitor, for as long as the TVTTM is inside the patient's trachea.

The provided text does not contain information about acceptance criteria or specific studies detailing device performance against those criteria. It focuses on regulatory approval (510(k) submission) for the ETView Tracheoscopic Ventilation Tube System (TVT™).

Here's an analysis of what is available:

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

This information is not present in the provided text. The document states that the device was "tested and complies with" several ISO and ANSI/AAMI standards, and that "Performance testing demonstrated that the ETView Tracheoscopic Ventilation Tube (TVT™) is as safe and effective as the cleared predicate device." However, it does not specify the acceptance criteria for these tests or the quantitative results of the performance.

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

This information is not present in the provided text. The document refers to "Performance Testing" in general terms but does not detail the methodology, sample sizes, or data provenance.

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 information is not present in the provided text. The document does not describe any specific studies relying on expert ground truth for a test set.

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

This information is not present in the provided text.

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 information is not present in the provided text. The device described is an endotracheal tube with an embedded video imaging device, not an AI-powered diagnostic tool for which an MRMC study would typically be conducted.

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

This information is not present in the provided text. The device provides a video image to a human user, implying human-in-the-loop performance, rather than standalone algorithmic performance.

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

This information is not present in the provided text.

8. The sample size for the training set:

This information is not present in the provided text. If any training was done for an embedded system, it is not described.

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

This information is not present in the provided text.

Summary of what is discussed in the provided text regarding device performance and compliance:

The ETView Tracheoscopic Ventilation Tube (TVT™) was found to be "substantially equivalent" to its predicate device (ETView Tracheoscopic Ventilation Tube K082420 and Coopdech Endobronchial Blocker tube K093888).

The device "was tested and complies with the following standards":

• ISO 5361:1999 Anesthetic and respiratory equipment -- Tracheal tubes and connectors
• ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide
• ISO 14971-1:2007 Risk management for medical devices
• ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing

The document states that "Performance testing demonstrated that the ETView Tracheoscopic Ventilation Tube (TVT™) is as safe and effective as the cleared predicate device" and that "the minor addition to the indication for use is safe and effective." Additionally, materials in contact with the human body were "tested and found to be biocompatible in accordance with ISO 10993-1." However, the specific details of these performance tests, including acceptance criteria, sample sizes, and quantitative results, are not provided in this summary.

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

The ETView Viva EB is designed to administer one-lung ventilation, by using a conventional endotracheal tube and a fiber optic bronchoscope. The device consists of a bronchial blocker tube, advanced through an endotracheal tube, and a joint connector, connecting the bronchial blocker tube to the endotracheal catheter. A cuff, incorporated at the distal tip of the tube, is inflated to block the targeted bronchus.

The provided document is a 510(k) summary for the ETView Viva EB, an endobronchial blocker. This type of regulatory submission primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way a clinical trial for a novel drug or a high-risk device might.

Therefore, the information available in the document does not include the detailed breakdown of acceptance criteria and a study proving those criteria were met in the typical sense for an AI/algorithm-based device. Instead, it focuses on demonstrating that the device is as safe and effective as previously cleared devices through performance testing against established standards and a comparison of features.

Here's an analysis based on the provided text, addressing your points where possible, and noting limitations:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in a quantitative table format for a clinical outcome. Instead, it states that the device was tested and complies with several ISO/ANSI standards. These standards inherently contain performance criteria that must be met. The "Performance Testing" section lists the types of tests conducted, implying that the device met the requirements outlined in those tests and standards.

Since specific quantitative acceptance criteria and their corresponding reported performance values are not provided in the text for clinical outcomes, I will list the types of performance tests conducted, implying they met the underlying standard requirements.

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 describes performance testing which refers to engineering and bench testing relevant to the physical properties and functionality of the device (e.g., cuff strength, dimensions, inflation). It does not describe a clinical study in humans or animals with a "test set" sample size for evaluating clinical efficacy or safety in a patient population. Therefore, this information is not available in the provided text. The "data provenance" similarly refers to the bench testing environment, not 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 N/A. The testing described is physical performance testing, not involving expert interpretation or "ground truth" establishment in a clinical context.

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

This N/A for the same reasons as above.

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 N/A. The device is an endobronchial blocker, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not applicable.

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

This N/A. The device is a physical medical device, not an algorithm.

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

For the physical performance tests, the "ground truth" would be established by the engineering specifications and established standards (e.g., ISO 5361). The device's performance is compared against these predetermined specifications to ensure compliance.

8. The sample size for the training set

This N/A. The device is a physical medical device, and the testing described is not related to machine learning or AI.

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

This N/A. (See point 8)

Summary of what the document does provide regarding meeting criteria:

The primary method for "proving" the device meets acceptance criteria, in the context of this 510(k) submission, is through:

• Compliance with recognized international standards: ISO 5361:1999, ANSI/AAMI/ISO 11135-1:2007, ISO 14971-1:2007, and ISO 10993-1:2003(E). These standards define performance and safety requirements.
• Performance Testing: A series of specific engineering tests (listed under "Performance Testing" in section {2}) were conducted to demonstrate that the device functions as intended and meets the requirements stipulated by the standards, and is comparable to predicate devices.
• Substantial Equivalence: The overarching study and argument is that the Viva EB is "as safe and effective as the cleared predicate devices" and that its "minor differences...do not raise any new questions of safety or efficacy." This is the core of a 510(k) submission.

In essence, for this type of device and regulatory pathway, the "acceptance criteria" are the requirements outlined in the referenced standards and the implicit performance demonstrated by predicate devices, and the "study" is the battery of engineering/bench tests confirming the device's physical properties and functionality meet these criteria.

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The ETView Double Lumen Video Tracheoscope (DLVT™) 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 DLVT™ System is indicated for verifying tube placement and repositioning.

The ETView Double Lumen Video Tracheoscope (DLVT™) System functions as a standard 37 French size 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 DLVT™ 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. The device is indicated for non-MRI environment only.

The provided text describes the ETView Double Lumen Video Tracheoscope (DLVT™) System and its performance testing for 510(k) clearance, but it does not include acceptance criteria in a table format, nor does it detail a study that explicitly 'proves' the device meets acceptance criteria in the way a clinical trial might for AI/ML devices. Instead, the document outlines a series of performance tests to demonstrate substantial equivalence to predicate devices.

However, based on the provided text, I can infer the general approach and key information relevant to your request, adapting the structure to fit the available data.

Here's a breakdown of the requested information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table with corresponding device performance metrics for features like sensitivity, specificity, or accuracy, which are typical for AI/ML devices. Instead, the acceptance criteria are demonstrated through compliance with established medical device standards and functional testing for properties like flow, diameter, and material integrity. The "reported device performance" is essentially that the device "complies with the following standards" and "demonstrated that the Double Lumen Video Tracheoscope (DLVT™) is as safe and effective as the cleared predicate devices."

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

The document mentions a "Cadaver Test" as part of performance testing. However, it does not specify the sample size (i.e., number of cadavers) used for this test. It also does not explicitly state the country of origin for the cadaver data or whether it was retrospective or prospective. Given it's a cadaver test, it would be considered a prospective test for the device's functional performance in a cadaveric model.

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

The document does not specify the number of experts or their qualifications used to evaluate the Cadaver Test results. Given the nature of a 510(k) for a medical device (as opposed to an AI/ML diagnostic tool), such details are often less extensively documented in the summary unless it involves subjective interpretation of images that are integral to a diagnostic claim.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the Cadaver Test or any other performance testing.

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 document describes a traditional medical device (a video tracheoscope) and not an AI/ML-driven diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed/reported.

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

This device is not an algorithm, so standalone algorithm performance is not applicable. The DLVT™ System is a physical medical device that provides direct video visualization for a clinician.

7. The Type of Ground Truth Used

For the functional performance tests, particularly the "Cadaver Test" regarding verifying tube placement and repositioning, the "ground truth" would be established by direct observation and professional judgment of the clinicians/researchers performing the test. For the other tests (e.g., cuff integrity, airflow), the ground truth is based on objective measurements against engineering and physical standards. There is no mention of pathology, outcome data, or expert consensus in the context of a diagnostic ground truth.

8. The Sample Size for the Training Set

This device is a physical medical instrument, not an AI/ML algorithm that requires a training set. Therefore, a training set sample size is not applicable.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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The ETView Tracheoscopic Ventilation Tube (TVT) is intended for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVT) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The TVT System is indicated for viewing during non-difficult and difficult intubation procedures, for verifying tube placement and repositioning, for viewing during suctioning and for general inspection of the airway.

The ETView Tracheoscopic Ventilation Tube (TVT) System is a visualized endotracheal tube The ETV10 Pacelleosooped Pulmonx VETT System (K973191), except that the ETView System same as tiny CMOS video camera and light source and the Pulmonx device uses fiberoptic components.

The provided document is a 510(k) summary for the ETView Tracheoscopic Ventilation Tube (TVT) System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves acceptance criteria for a new AI/software device. As such, information regarding acceptance criteria and performance studies in the context of AI/software device evaluation (e.g., sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not present in this document.

However, I can extract information about the performance testing conducted for this device, which might be considered the "acceptance criteria" based on the substantial equivalence pathway.

Here's a summary based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The study described is a series of bench tests and a comparison to a predicate device (Pulmonx Visualized Endotracheal Tube - VETT). The core of the "proof" is the demonstration of substantial equivalence, meaning the TVT is at least as safe and effective as the legally marketed predicate.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text. The testing was bench testing, not clinical studies with patients.
• Data Provenance: Not applicable in the context of clinical data. The tests would have been performed in a laboratory setting by the manufacturer (ETView Ltd. in Israel).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is bench testing comparing physical and functional characteristics, not evaluation of AI/software performance with human expert ground truth.

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

• Not applicable as this is bench testing.

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, an MRMC comparative effectiveness study was not done. This device is a physical endotracheal tube with an integrated camera, not an AI/software diagnostic tool for image interpretation.

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

• Not applicable. The "imaging performance" listed refers to the camera's ability to produce an image, not an algorithm's performance.

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

• For the bench tests, the "ground truth" would be the established engineering and medical device standards (e.g., ISO 5361, ANSI/AAMI/ISO 11135) and the performance characteristics of the predicate device.

8. The sample size for the training set:

• Not applicable as this is not an AI/machine learning device requiring a training set in that sense.

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

• Not applicable.

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