(113 days)
The ProVu Endotracheal Tube with Video Stylet is intended for intubation procedures. The ProVu Endotracheal Tube with Video Stylet is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.
The ProVu Endotracheal Tube with Video Stylet is indicated for viewing during non-difficult and difficult intubation procedures and for verifying endotracheal tube placement.
The ProVu Video Stylet with Reinforced ET Tube is a sterile, single-use, video-enabled stylet and ETT intubation system with malleable and directional control intended to assist with oral and nasal intubations and designed for use in adults in a hospital environment.
The device comprises of two main components:
- The ProVu Reinforced Endotracheal tube
- The ProVu Video Stylet (with a removable malleable rod)
The provided FDA 510(k) clearance letter and summary for the ProVu Single Use Video Stylet with Reinforced ET Tube does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to its clinical performance or diagnostic accuracy.
The summary focuses on non-clinical data to demonstrate substantial equivalence to a predicate device. This typically means the device has similar technological characteristics and indications for use, and does not raise new questions of safety or effectiveness. The included sections detail biocompatibility, sterilization, electrical safety, bench performance, and usability, but none of these address how well the device performs its intended clinical function (e.g., successful intubation, accurate verification of tube placement) against specific performance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the given text.
Here's an analysis of why each requested point cannot be answered:
- A table of acceptance criteria and the reported device performance: Not provided. The summary lists standards the device complies with (e.g., ISO 5361, IEC 60601-1), which are design and safety standards, not clinical performance acceptance criteria.
- Sample size used for the test set and the data provenance: Not provided. No test set for clinical performance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No ground truth for clinical performance is mentioned.
- Adjudication method for the test set: Not provided. No clinical test set is mentioned.
- 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 device is not an AI-assisted diagnostic tool for "human readers" in the sense of image interpretation. It's a video stylet for direct visualization during intubation. The concept of "AI assistance" and "effect size of human readers" doesn't apply to the reported information.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device. It's a physical medical device that assists human operators in a procedure.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. No clinical ground truth is mentioned.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
Summary of what was reported in the 510(k) information:
- Non-clinical data provided:
- Biocompatibility testing: Evaluated per ISO 10993-1 and ISO 18562 (Cytotoxicity, Sensitization, Intracutaneous reactivity, Material Mediated Pyrogenicity, Subcutaneous Implantation, Chemical Characterisation, Toxicological Risk Assessment, Gas Pathway Testing).
- Sterilization and shelf-life testing: Validated according to ISO 11135:2014, EO/ECH residual test per ISO 10993-7:2008. Shelf-life of 0.5 year.
- Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1, IEC60601-2-18, and IEC 60601-1-2.
- Bench performance testing: Complies with ISO 5361, ISO 5356-1.
- Usability validation: Conducted according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices".
- Clinical Study: Explicitly stated as "Not applicable."
This is characteristic of a 510(k) submission where substantial equivalence is demonstrated through non-clinical performance and technological comparison, rather than requiring new clinical efficacy or effectiveness data.
§ 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).