(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.]
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.