(19 days)
The Peel-Away Introducer Set is intended for the percutaneous introduction of balloon, electrode and closed or nontapered end catheters into central and peripheral vasculature, and for nonvascular use.
The Peel-Away Introducer Set is a single-use, sterile, disposable product that is used to provide initial percutaneous access. It is comprised of a co-axial introducer assembly (peel-away sheath and dilator). Set may contain a wire guide in a size fitted to the endhole of the dilator and may contain an access needle in a gage that allows the included wire guide to pass through its lumen. Additional set components (e.g., luer-slip syringe) are available.
The provided text describes a 510(k) premarket notification for a medical device called the "Peel-Away Introducer Set." This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics in the way an AI/ML device submission would.
Therefore, much of the requested information (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, sample size for training set, and how ground truth for training set was established) is not applicable to this type of device submission as it does not involve AI/ML or diagnostic performance evaluation against a defined ground truth.
However, I can extract the acceptance criteria and reported "performance" in the context of the engineering and biocompatibility tests conducted.
Here's the information that can be extracted or derived:
1. A table of acceptance criteria and the reported device performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Materials and methods must be nontoxic and meet acceptance criteria for intended use (in accordance with BS EN ISO 10993-1:2003). | Met the acceptance criteria for their intended use. |
| Introducer Assembly (Radiopacity) | Shaft gradient must fall along the gradient of an aluminum X-ray step wedge gauge (following ASTM F6540-12). | Test results met predetermined criteria. |
| Introducer Dilator (Tensile Testing) | 90% of test articles at 95% confidence must meet or exceed the requirements of BS EN ISO 11070: 2014. | Test results met predetermined criteria. |
| Introducer Sheath (Peel Force) | (Implied: Successful characterization of peel force across various sheath sizes, indicating consistent and appropriate peeling characteristics.) Specific numerical criteria not explicitly stated in this summary. | Characterization of peel force for various Peel-Away Introducer sheath sizes was successfully performed. |
| Wire Guide (Corrosion, Flex, Fracture, and Tensile Testing) | Shall not show signs of corrosion, defect, damage, or fracture that could affect functional performance. Must demonstrate minimal tensile strength for wire guides of a certain diameter as per standard. | Test articles did not show signs of corrosion, defect, damage, or fracture. Test results met predetermined criteria for tensile strength. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each of the engineering tests (e.g., number of introducer assemblies, dilators, or wire guides tested). The tests are performed on the device components themselves, not on patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are engineering and material tests, not clinical performance or diagnostic studies requiring expert review of a "ground truth" established from patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to clinical or diagnostic study adjudication of patient cases, which is not described here.
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. This device is an introducer set, not an AI/ML diagnostic device. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the engineering tests, the "ground truth" is defined by established international standards (e.g., BS EN ISO 10993-1:2003, ASTM F6540-12, BS EN ISO 11070: 2014) and predetermined internal criteria for physical properties and material safety.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 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).