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The ETView Tracheoscopic Ventilation Tube (TVTM) is intended for intubation procedures. The ETView Tracheoscopic Ventilation Tube (TVTM) 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 endotracheal tube and endobronchial blocker placement and repositioning, for viewing during suctioning and for general inspection of the airway.

The ETView Tracheoscopic Ventilation Tube (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 TVTTM is inside the patient's trachea.

The provided text does not contain information about acceptance criteria or specific studies detailing device performance against those criteria. It focuses on regulatory approval (510(k) submission) for the ETView Tracheoscopic Ventilation Tube System (TVT™).

Here's an analysis of what is available:

1. A table of acceptance criteria and the reported device performance:

This information is not present in the provided text. The document states that the device was "tested and complies with" several ISO and ANSI/AAMI standards, and that "Performance testing demonstrated that the ETView Tracheoscopic Ventilation Tube (TVT™) is as safe and effective as the cleared predicate device." However, it does not specify the acceptance criteria for these tests or the quantitative results of the performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not present in the provided text. The document refers to "Performance Testing" in general terms but does not detail the methodology, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not present in the provided text. The document does not describe any specific studies relying on expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not present in the provided text.

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:

This information is not present in the provided text. The device described is an endotracheal tube with an embedded video imaging device, not an AI-powered diagnostic tool for which an MRMC study would typically be conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not present in the provided text. The device provides a video image to a human user, implying human-in-the-loop performance, rather than standalone algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not present in the provided text.

8. The sample size for the training set:

This information is not present in the provided text. If any training was done for an embedded system, it is not described.

9. How the ground truth for the training set was established:

This information is not present in the provided text.

Summary of what is discussed in the provided text regarding device performance and compliance:

The ETView Tracheoscopic Ventilation Tube (TVT™) was found to be "substantially equivalent" to its predicate device (ETView Tracheoscopic Ventilation Tube K082420 and Coopdech Endobronchial Blocker tube K093888).

The device "was tested and complies with the following standards":

• ISO 5361:1999 Anesthetic and respiratory equipment -- Tracheal tubes and connectors
• ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide
• ISO 14971-1:2007 Risk management for medical devices
• ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing

The document states that "Performance testing demonstrated that the ETView Tracheoscopic Ventilation Tube (TVT™) is as safe and effective as the cleared predicate device" and that "the minor addition to the indication for use is safe and effective." Additionally, materials in contact with the human body were "tested and found to be biocompatible in accordance with ISO 10993-1." However, the specific details of these performance tests, including acceptance criteria, sample sizes, and quantitative results, are not provided in this summary.

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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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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 Tracheoscopic Ventilation Tube (TVT) System is a visualized endotracheal tube The ETV10 Pacelleosooped Pulmonx VETT System (K973191), except that the ETView System same as tiny CMOS video camera and light source and the Pulmonx device uses fiberoptic components.

The provided document is a 510(k) summary for the ETView Tracheoscopic Ventilation Tube (TVT) System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves acceptance criteria for a new AI/software device. As such, information regarding acceptance criteria and performance studies in the context of AI/software device evaluation (e.g., sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not present in this document.

However, I can extract information about the performance testing conducted for this device, which might be considered the "acceptance criteria" based on the substantial equivalence pathway.

Here's a summary based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The study described is a series of bench tests and a comparison to a predicate device (Pulmonx Visualized Endotracheal Tube - VETT). The core of the "proof" is the demonstration of substantial equivalence, meaning the TVT is at least as safe and effective as the legally marketed predicate.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text. The testing was bench testing, not clinical studies with patients.
• Data Provenance: Not applicable in the context of clinical data. The tests would have been performed in a laboratory setting by the manufacturer (ETView Ltd. in Israel).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is bench testing comparing physical and functional characteristics, not evaluation of AI/software performance with human expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as this is bench testing.

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. This device is a physical endotracheal tube with an integrated camera, not an AI/software diagnostic tool for image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. The "imaging performance" listed refers to the camera's ability to produce an image, not an algorithm's performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the bench tests, the "ground truth" would be the established engineering and medical device standards (e.g., ISO 5361, ANSI/AAMI/ISO 11135) and the performance characteristics of the predicate device.

8. The sample size for the training set:

• Not applicable as this is not an AI/machine learning device requiring a training set in that sense.

9. How the ground truth for the training set was established:

• Not applicable.

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