(28 days)
The Intri24 Introducer Sheath is indicated to provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
The Intri24 Introducer Sheath is a single-use over-the-wire system intended for use in vessels > 9 mm and is a conduit for the insertion of diagnostic or endovascular devices into the peripheral vasculature. The Intri24 Introducer Sheath consists of a Sheath and Dilator. The Sheath is comprised of a single lumen catheter with a hydrophilic coating, a proximal hemostasis valve, and stopcock with flush port. A radiopaque marker is positioned near the distal tip of the sheath to aid with fluoroscopic visualization. The Dilator is 0.035" guidewire compatible and attaches to the hemostasis valve on the Sheath. The Dilator has a tapered edge to aid in the dilation of the target vessel for insertion and positioning of the Sheath.
The provided text describes a medical device, the Intri24 Introducer Sheath, and its regulatory clearance. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The tests described are primarily related to mechanical performance, biocompatibility, and sterilization of a physical medical device, not the performance of an AI algorithm or model.
Therefore, I cannot provide the information requested in your prompt based on the given text.
Specifically:
- Table of acceptance criteria and reported device performance: This information is not present for AI/ML performance. The document lists non-clinical performance tests for the physical introducer sheath (e.g., visual inspection, dimensional inspection, tensile testing, fluid leak tests), but these are not related to an AI/ML device's performance.
- Sample size for test set and data provenance: Not applicable, as there's no AI/ML test set discussed.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
The document discusses "design verification testing" and lists various mechanical and functional tests for the introducer sheath, but these are for a traditional hardware device, not an AI/ML-powered one.
§ 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).