(201 days)
The Traveler™ Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
The Traveler™ Portal Vein Access Set contains a 10F wall-reinforced Introducer Sheath with radiopaque tip, a 10F Dilator, a 5F MPA catheter, a puncturing tool that comes in the following variations: 0.038" Stylet with a 5Fr Stylet Catheter (separated with a removable spacer clip), a 21ga Needle/5Fr Catheter or 16ga Needle/7Fr Catheter (both are separated with a removable spacer clip) and a bending tool. The 14ga stiffening cannula with cannula sheath and the 16ga needle have a curved end, with a directional handle that indicates the direction of the curve. The 10F Introducer Sheath hemostatic valve is designed to allow entry of a 13F (4.3mm/0.171") access sleeve but taper down to a 10F inner diameter. These components are used to create a pathway through the liver parenchyma through which an endoprosthetic can be delivered. The Portal Vein Access Set is used to gain access to the hepatic vein and guide a sharp puncture tool toward the parenchyma. The puncture tool is used to make a pathway from the hepatic vein to the portal vein, and then the pathway is dilated to provide access for the 10F Introducer Sheath. The shunt is inserted through the sheath and deployed through the pathway. Then, all of the Portal Vein Access Set components are removed. The Portal Vein Access Set is typically in use in procedures up to 4 hours.
The provided text is a 510(k) Summary for a medical device (Traveler Portal Vein Access Set), not a study report for an AI/CAD/imaging device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or details about MRMC studies, which are typically associated with AI or imaging diagnostics.
This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance testing and biocompatibility testing for a physical medical device (a catheter introducer).
Here's how the provided information relates to your request, and what is missing due to the nature of the device:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document states that a series of tests were conducted "to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not provide a table with specific quantitative acceptance criteria (e.g., "burst pressure must be > X psi") or the exact reported performance values from those tests. It broadly lists the types of tests performed.
- Reported Device Performance: The document only states that the device "were shown to meet the acceptance criteria." No specific numerical performance values for tests like "Tensile Strength," "Torque Strength Test," "Burst Pressure," etc., are reported in the provided text.
List of Tests Performed (from text, acting as performance areas):
| Acceptance Criteria Area | Reported Device Performance |
|---|---|
| Dimensional & Functional Fit | Met acceptance criteria (no specific values provided) |
| Surface Inspection | Met acceptance criteria (no specific values provided) |
| Component Compatibility | Met acceptance criteria (no specific values provided) |
| Tensile Strength | Met acceptance criteria (no specific values provided) |
| Torque Strength Test | Met acceptance criteria (no specific values provided) |
| Liquid Leakage | Met acceptance criteria (no specific values provided) |
| Air Leakage | Met acceptance criteria (no specific values provided) |
| Burst Pressure | Met acceptance criteria (no specific values provided) |
| Flow Rate | Met acceptance criteria (no specific values provided) |
| Corrosion Resistance | Met acceptance criteria (no specific values provided) |
| Simulative Use | Met acceptance criteria (no specific values provided) |
| Radiopacity | Met acceptance criteria (no specific values provided) |
| Echogenicity | Met acceptance criteria (no specific values provided) |
| Luer Connector Functional Testing | Met acceptance criteria (no specific values provided) |
| Resistance to Fracture Testing | Met acceptance criteria (no specific values provided) |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material Mediated Pyrogen, Hemocompatibility) | Met acceptance criteria (no specific values provided for each test) |
| Shipping Test | Met acceptance criteria (no specific values provided) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document refers to "a series of testing" but does not give the number of units/samples tested for each performance criterion.
- Data Provenance: The tests are non-clinical, likely performed in an engineering lab. The "data provenance" in terms of patient data (country of origin, retrospective/prospective) is not applicable or provided as this is a physical device, not an AI/imaging diagnostic.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a catheter introducer, not an AI diagnostic that requires expert interpretation for ground truth establishment. The "ground truth" for this device would be its physical conformance to specifications and its performance in defined engineering tests.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies involving interpretation (e.g., radiology reads). For a physical device, performance is typically measured against objective criteria without "adjudication" in this sense.
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. This is not an AI/CAD system. No MRMC study was done, nor would it be relevant for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For the physical properties and performance tests, the "ground truth" would be the engineering specifications, industry standards, and established test methodologies (e.g., ISO standards for biocompatibility). There is no "expert consensus" or "pathology" ground truth in this context.
8. The sample size for the training set:
- Not applicable. This device is not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
In summary, the provided document is a regulatory submission for a physical medical device (catheter introducer) aiming for 510(k) clearance based on substantial equivalence. It is not an evaluation report for an AI/CAD/imaging device. Therefore, most of the detailed information you requested regarding AI performance metrics, clinical study design, and ground truth establishment for AI models is not present and not relevant to this type of 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).