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510(k) Data Aggregation
(62 days)
The wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System is comprised of a balloon-expandable stent mounted on 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 wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System and an FDA clearance letter. It does not contain information about specific acceptance criteria or a study proving the device meets them in the format requested.
The document primarily focuses on establishing substantial equivalence to predicate devices based on:
- Intended Use: Palliation of malignant neoplasms in the biliary tree.
- Design and Principle of Operation.
- Biocompatibility: Stated that "all materials are biocompatible."
- Performance Characteristics: Stated that "physical properties are appropriate for the intended use."
- Non-clinical testing: "Non-clinical testing was conducted."
Without a detailed study report, I cannot complete the requested information. The document explicitly states: "Abbott Vascular Devices has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System is substantially equivalent to currently marketed predicate device." This indicates that the regulatory clearance was based on equivalence, not necessarily on a novel clinical study with explicit acceptance criteria for performance metrics.
Therefore, I cannot provide the requested table and detailed study information as it is not present in the provided text.
If this were a typical request, and if such a study were present, the information would be structured as follows (and I would fill it in if the data was available):
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| [Example: Primary Patency Rate] | [Example: > 70% at 6 months] | [Example: 78% (95% CI: 72-84%)] |
| [Example: Adverse Event Rate (specific type)] | [Example: 95%] | [Example: 98%] |
| (Detailed metrics regarding stent expansion, migration, fracture, etc., would be listed here if available) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): [Not provided in the document]
- Data Provenance: [Not provided in the document; typically includes country of origin, retrospective/prospective, multicenter/single-center]
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: [Not provided in the document]
- Qualifications of Experts: [Not provided in the document; example: Interventional Radiologists with 10+ years of experience in biliary interventions]
4. Adjudication method for the test set
- Adjudication Method: [Not provided in the document; example: 2+1 (2 reviewers agree, 3rd resolves disagreement) or consensus panel]
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
- MRMC Study: No, this device is a physical medical device (stent), not an AI/software device intended for diagnostic interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, this is a physical medical device (stent), not an AI/software device.
7. The type of ground truth used
- Type of Ground Truth: [Not explicitly detailed, but for a stent, ground truth typically relates to outcomes data like patency, re-intervention rates, complication rates, and possibly histological confirmation of malignancy for inclusion criteria.]
8. The sample size for the training set
- Sample Size (Training Set): [Not applicable or not provided. For a physical device based on substantial equivalence, there isn't typically a "training set" in the machine learning sense.]
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): [Not applicable for this type of device and submission.]
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