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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 TVT™ is a single use, cuffed, endotracheal tube with an embedded video imaging device, and light source at its tip and integrated cable with connector to transfer the video signal to the display. The video image is displayed for as long as the Endotracheal tube (ETT) is inside the patient's trachea. The video image can be displayed on ETView's display or on most other TV/VCR displays.

The ETView Tracheoscopic Ventilation Tube (TVT™) system consists of:

• Endotracheal tube (ETT) with: .
  • Embedded Video camera o
  • Embedded Light source ం
  • Integrated cable with connector o
• Monitor .

The provided text describes a 510k submission for the ETView Tracheoscopic Ventilation Tube (TVT™) and focuses on establishing substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, comprehensive study results demonstrating device performance against those criteria, or details regarding the methodologies for establishing ground truth, sample sizes for test and training sets, or expert involvement as typically found in a clinical study report for AI/CADe devices.

The submission primarily focuses on:

• Device Description and Intended Use: The TVT™ is a single-use, cuffed endotracheal tube with an embedded video imaging device and light source for intubation procedures, verifying tube placement, repositioning, suctioning, and general airway inspection.
• Technological Modifications: The new device features a "new generation of camera" and a standard NTSC signal output.
• Substantial Equivalence Claim: The manufacturer claims substantial equivalence to its predicate (K052233) based on the same intended use, technology (embedded camera and light source), and material.
• Performance Validation (Bench Tests): "Series of bench tests were performed to ensure that the device performs as intended. Tests were done according to ISO 5361:1999 Anaesthetic and respiratory equipment - Tracheal tubes and according to ISO 10933-1:2003 (for surface device-mucosal membrane-prolonged duration). All testing results demonstrated satisfactory performance."
• Biocompatibility Testing: Materials were tested and found biocompatible in accordance with ISO 10993-1.

Therefore, it is not possible to fill out the requested table and answer the detailed questions regarding acceptance criteria and a study proving their fulfillment.

The document is a submission for a medical device (endotracheal tube) with an imaging component, not an AI/CADe system for which criteria like sensitivity, specificity, or AUC against a ground truth would be defined. The "performance validation" mentioned refers to bench testing against international standards for tracheal tubes and biocompatibility, not clinical efficacy or diagnostic accuracy studies.

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