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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-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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