(139 days)
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.
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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
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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.
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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.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).