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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-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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