(124 days)
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:
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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.
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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).
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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.
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).