(65 days)
The Twin-Pass OTW Catheter is to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
The Vascular Solutions Twin-Pass OTW Catheter is a sterile single use device designed for use in the arterial vasculature. The catheter provides support for 0.014"/0.36mm guidewires during interventional procedures, and the dual lumen design allows for the delivery of a second guidewire, contrast, or medication into distal vasculature while leaving the initial guidewire in place.
The provided 510(k) summary is for a medical device (Twin-Pass™ OTW Dual Access Catheter) and does not describe an AI/ML powered device or a study involving such a device. Therefore, most of the requested information regarding AI/ML device performance, ground truth, expert adjudication, training/test sets, and MRMC studies is not applicable.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for each test. Instead, it lists the non-clinical tests conducted and states that "The results of this testing confirmed the suitability of the Twin-Pass OTW Catheter for its intended use."
The non-clinical tests performed are:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Tortuosity | Confirmed suitability for intended use |
| Catheter Kink Resistance | Confirmed suitability for intended use |
| Radiopaque Markerband | Confirmed suitability for intended use |
| Hub-to-proximal-shaft Bond Strength | Confirmed suitability for intended use |
| Proximal-to-distal-shaft Bond Strength | Confirmed suitability for intended use |
| Fluid Leak Under Pressure | Confirmed suitability for intended use |
| Air Leak During Aspiration | Confirmed suitability for intended use |
| Flow Rate (Infuse and Distal Lumen) | Confirmed suitability for intended use |
| Infuse Lumen Flow Rate | Confirmed suitability for intended use |
| Guidewire Interface | Confirmed suitability for intended use |
| Guide Catheter Interface | Confirmed suitability for intended use |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document mentions "testing conducted," but does not specify sample sizes for these tests, nor the provenance of any data (as it's non-clinical bench testing).
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. This is not an AI/ML device, and no human "experts" were used to establish ground truth for clinical performance; the testing was non-clinical bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device, and no human adjudication was involved in the 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
Not applicable. No clinical testing was conducted, and this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" would be established by engineering specifications, physical measurements, and industry standards for catheter performance (e.g., flow rate measurements, kink resistance thresholds). The document simply states that the tests "confirmed the suitability."
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment process.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).