(92 days)
The Vitaid ET Tubes are designed for oral / nasal intubation and are indicated for airway management. The Vitaid ET tubes have an ultra thin inflatable cuff.
The Vitaid endotracheal tubes are available in sizes 3.0 mm in increments of 0.5 mm. They are available cuffed, uncuffed and with Murphy eye. Some are pre-formed, they are made with a ultra thin urethane cuff, referred to as the MicroCuff.
The provided document is a 510(k) summary for a medical device (Vitaid ET Tubes), which focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria and results in the manner typically seen for novel AI/software devices. This document does not describe a study involving an algorithm's performance, human readers, or ground truth establishment.
Therefore, the requested information elements related to algorithmic performance studies (e.g., test set sample size, number of experts, adjudication, MRMC studies, standalone performance, training set) cannot be extracted from this document.
The document states that there are "no significant differences" between the proposed device and the identified predicates. The substantial equivalence is based on attributes like indications for use, environments of use, patient population, contraindications, technology, material (with a noted difference in cuff material), sizes, and sterility.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific acceptance criteria in terms of quantitative performance metrics for the device, nor does it report performance against such criteria. Instead, it relies on the concept of substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if the device is found to be substantially equivalent to devices already on the market.
| Attribute/Criterion | Vitaid ET Tubes Description/Performance | Predicate Devices Description | Commentary on Equivalence |
|---|---|---|---|
| Indications for Use | Designed for oral/nasal intubation, indicated for airway management. Has an ultra-thin inflatable cuff. | Same | Substantially Equivalent |
| Environments of Use | Institutional (Hospital, Sub-acute), Pre-hospital (emergency services) | Same | Substantially Equivalent |
| Patient Population | Patients requiring intubation | Same | Substantially Equivalent |
| Contraindications | Use in procedures involving laser beams or electrosurgical active electrodes in the immediate area due to combustion risk. | Same | Substantially Equivalent |
| Technology | Endotracheal Tube | Endotracheal Tube | Substantially Equivalent |
| Material | Tube - PVC, Cuff - Polyurethane | Tube - PVC, Cuff - PVC | Difference noted (cuff material), but deemed not significant for equivalence. |
| Sizes | 3.0 mm to 10.0 mm | Yes | Substantially Equivalent |
| Configuration | Cuffed and uncuffed, pre-formed with and without Murphy eye | Yes | Substantially Equivalent |
| Sterility | Supplied Sterile | Yes | Substantially Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a submission for a physical medical device (endotracheal tube) based on substantial equivalence to existing predicate devices, not a study involving a test set of data for an algorithm or software. No data provenance is mentioned as it's not a data-driven study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No "ground truth" was established in the context of an algorithmic performance study. The evaluation is based on comparison of physical device attributes and intended use.
4. Adjudication Method for the Test Set
Not applicable. There was no test set or human adjudication process as part of an algorithmic performance study.
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. This is not an AI/software device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used
Not applicable. The concept of "ground truth" as typically applied in AI/software performance studies is not relevant here. The "truth" for this submission is based on engineering specifications, material properties, and intended use comparison to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an algorithm or AI.
9. How the ground truth for the training set was established
Not applicable.
§ 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).