(207 days)
The NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is indicated for oral/tracheal intubation for anesthesia, airway management and removal of accumulated subglottic secretions. It is indicated for singlepatient, single-use only.
The NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with preloaded stylet is a disposable, sterile, single-patient, single use device. The NeVap ASSET is packaged individually and supplied sterile with a standard 15mm connector and preloaded stylet. The NeVap ASSET is a Magill curved construction with primary lumen for patient ventilation. Two (2) narrower lumens within the primary wall are used for cuff inflation and subglottic evacuation (vacuum). A low pressure, conformable cuff is inflated through the inflation line with pilot balloon using a standard 10cc syringe (air only) through a one-way check valve. For evacuation of subglottic secretions, a separate (yellow) suction line, with male fitting, connects to standard hospital vacuum receptacles. Once properly intubated, subglottic secretions are evacuated through the suction appendage just superior to the cuff. To facilitate proper positioning, the suction appendage and lumen line marker are radiopaque.
The provided text refers to a medical device, the NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet, and its demonstration of substantial equivalence to a predicate device. However, it does not contain the detailed results of a study that would include acceptance criteria and specific device performance metrics in the format requested, such as sensitivity, specificity, or AUC for an AI-powered device.
The document primarily focuses on bench testing, biocompatibility testing, sterilization validation, and a human factors/usability study to demonstrate that the device performs as intended and is substantially equivalent to its predicate.
Therefore, many of the requested categories for an AI device study (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this particular document.
Here's a summary of the information that can be extracted or inferred from the provided text, recognizing the limitations of the input:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the NeVap ASSET met all predetermined acceptance criteria as specified by applicable standards, FDA guidance, and test protocols. However, it does not provide a table with these specific criteria or the quantitative "reported device performance" against them. It only lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Performance Bench Testing (ISO 5361:2016, ISO 5356-1:2015) | Conformance to standards demonstrated, performance verified as substantially equivalent to predicate device for intended use. |
| Biocompatibility Testing (ISO 10993-1:2009 & FDA guidance) | Cytotoxicity, Implantation, Sensitization, Irritation/Intracutaneous reactivity, Material Mediated Pyrogenicity, Chemical Characterization (Extractable & Leachable), Toxicological Risk Assessment all passed, demonstrating safety. |
| Sterilization (Ethylene Oxide) | Validation conducted. |
| Human Factors/Usability (IEC 62366-1:2015) | Found to be in conformance with the standard. |
| Risk Analysis (ISO 14971) | Possible hazards systematically identified and evaluated, mitigated to acceptable risk levels. |
| Suction-T Component Tests: | Met performance requirements for intended use. Specific tests included: Suction Patency Test, Fluid Recovery Rates determination, Suction-T Pull Test (Shear and Tensile Force), Isolated Suction-T Material Pull Test. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided for an AI output. The studies described are for a physical medical device. Bench tests involve samples of the device itself, but not a "test set" of data in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. This information is relevant for studies involving human interpretation or clinical evaluation, particularly for AI ground truth. For this physical device, "ground truth" would be established by physical measurements and adherence to engineering standards.
4. Adjudication method for the test set:
- Not applicable / Not provided. This is specific to studies involving expert review and often used in AI performance evaluation.
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 study was NOT done. The document explicitly states: "Clinical Testing was not conducted. Clinical evidence was not necessary to show substantial equivalence." This type of study would be relevant for an AI-assisted diagnostic tool, not for this physical endotracheal tube.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an algorithm, so a "standalone" AI performance study is irrelevant.
7. The type of ground truth used:
- For the physical device, "ground truth" is established through physical measurements against engineering standards and specifications, biocompatibility test results, and validation of manufacturing processes.
8. The sample size for the training set:
- Not applicable / Not provided. The device is not an AI algorithm.
9. How the ground truth for the training set was established:
- Not applicable. The device is not an AI algorithm.
§ 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).