(196 days)
THE VALVED TEARAWAY INTRODUCERS ARE INTENDED TO OBTAIN CENTRAL VENOUS ACCESS TO FACILITATE CATHETER INSERTION INTO THE CENTRAL VENOUS SYSTEM.
The Medcomp Valved Tearaway Introducer is a two-part single use device used to obtain vascular access and facilitate intravascular catheter insertion. The Medcomp Valved Tearaway Introducer consists of a peel-able introducer sheath which contains a "duckbill" seal to substantially minimize air/blood from entering or escaping when the dilator is removed. The dilator is comprised of a cylindrical tube with a locking hub; the sheath is also a cylindrical tube with a hub and valve. When the dilator is fully seated it snaps into the hub of the introducer sheath to prevent independent movement of either piece when in use. The dilator extends beyond the sheath to provide a zero tolerance clearance between sheath and dilator. The sheath and dilator when used in conjunction with an introducer needle and guidewire provide a means to obtain a percutaneous opening to the vascular system to facilitate the insertion of a catheter. After removing the dilator a catheter can then be placed through the sheath. Breaking the sheath's hub and peeling the sheath away from the catheter then allows the sheath to be removed. The dilator is composed of a High Density Polyethylene with Barium Sulfate for visibility under fluoroscopy by the attending physician during insertion. The sheath is composed of PTFE to provide a smooth, consistent peel.
The provided document, K090394, describes a 510(k) premarket notification for a medical device and therefore does not contain information on clinical studies or acceptance criteria for AI/ML performance. As such, I cannot populate most of the requested fields from the given text.
The document discusses the "Valved Tearaway Introducer" and establishes its substantial equivalence to predicate devices based on in vitro performance data and biocompatibility testing. It specifically states that "Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device."
Therefore,
- No acceptance criteria related to AI/ML performance are mentioned.
- No specific study proving device meets acceptance criteria is described.
Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for AI/ML. The general acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device in terms of intended use, design, material type, performance, and method of sterilization.
- Reported Device Performance: "In Vitro performance data for the Medcomp Valved Tearaway Introducer, including peel force, demonstrates that this device is substantially equivalent to the legally marketed devices." No specific quantitative metrics (e.g., specific peel force values) are provided in the summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document refers to "in-vitro testing" but does not specify sample sizes or data provenance. No test set for AI/ML evaluation is mentioned.
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)
- Not applicable. No ground truth establishment for a test set (clinical or otherwise) is described as no clinical studies or AI/ML evaluations were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as there was no clinical test set to adjudicate for AI/ML.
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. No MRMC study was done, as this device is a physical medical instrument, not an AI/ML algorithm for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical introducer, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device's regulatory approval was substantial equivalence to predicate devices based on in-vitro testing and biocompatibility, not clinical outcomes or expert consensus for AI/ML performance.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth for it is mentioned.
In summary, the provided text describes a 510(k) application for a physical medical device (Valved Tearaway Introducer) and explicitly states that clinical studies were not required. Therefore, the questions relating to AI/ML acceptance criteria, study methodologies, sample sizes, ground truth, and expert involvement are not applicable to this document.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).