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510(k) Data Aggregation
(72 days)
The Xpand™ Balloon-Expandable Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The Xpand™ Balloon-Expandable Transhepatic Biliary Stent System is comprised of a balloon-expandable stent mounted on the balloon of an over the wire (OTW) delivery system designed to deliver the stent to the biliary tree.
The provided text is a 510(k) summary for the Xpand™ Balloon-Expandable Transhepatic Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way one would see for a novel AI/software device.
Therefore, the requested information elements related to AI/software performance studies (such as specific performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies) are not present in this document.
However, I can extract the available information regarding the device and its demonstrated equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" or provide "reported device performance" in numerical metrics for the Xpand™ Stent System. Instead, the submission focuses on establishing substantial equivalence to a predicate device (wavemaX™ Transhepatic Biliary Stent, K033909) based on qualitative and certain non-clinical tests.
The criteria for substantial equivalence, which can be interpreted as the "acceptance criteria" in this context, are:
| Acceptance Criteria (based on Substantial Equivalence Claim) | Reported Device "Performance" (demonstration of equivalence) |
|---|---|
| Same intended use as predicate device | The Xpand™ Stent System has the same intended use: palliation of malignant neoplasms in the biliary tree. |
| Materials are biocompatible | Results of scientific testing ensured all materials are biocompatible. |
| No new adverse effects introduced | Scientific testing ensured no new adverse effects were introduced. |
| Physical properties appropriate for intended use | Scientific testing ensured physical properties are appropriate for the intended use. |
| Design and principle of operation are similar | Information on design and principle of operation was submitted to establish equivalence. |
| Performance characteristics are similar | Performance characteristics were submitted to establish equivalence (likely referring to non-clinical tests). |
2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device (stent) submission, not an AI/software device that would typically have a "test set" in the context of diagnostic performance evaluation. The data provenance would be related to the non-clinical testing performed on the device itself. The document mentions "non-clinical testing was conducted" but does not specify the sample size or further details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This information is typically relevant for diagnostic AI/software devices. The "ground truth" for a stent would be established through clinical outcomes, device integrity testing, and biocompatibility testing, not through expert consensus on a test set of images.
4. Adjudication method for the test set
Not applicable for a medical device's non-clinical 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. This is a medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used
For this type of device, the "ground truth" for demonstrating safety and effectiveness for substantial equivalence would generally derive from:
- Biocompatibility testing: Compliance with ISO standards for materials.
- Mechanical/Physical testing: Bench testing to evaluate stent expansion, radial strength, flexibility, fatigue resistance, and crimp integrity, compared to the predicate device.
- Sterilization validation: Ensuring the device can be sterilized effectively.
- Clinical experience/performance of the predicate device: The basis for establishing the safety and effectiveness of the equivalent device.
The document states: "Results of scientific testing have ensured that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use. Non-clinical testing was conducted." This implies that the ground truth was established through laboratory-based scientific testing and comparisons to established standards and the known performance of the predicate device.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI/software device.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI/software device.
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