(67 days)
The proposed 100mm Wallstent™ RX Biliary Endoprosthesis is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
The proposed Wallstent RX Biliary Endoprosthesis consists of a stent and a delivery catheter. The self-expanding metal stent is delivered endoscopically with the delivery catheter. The stent is a tubular mesh constructed from a biomedical super alloy wire with a tantalum core to allow for visibility under fluoroscopy. The stent is offered bare. The proposed delivery catheter consists of a coaxial tubing assembly that constrains the stent until it is released by retracting the exterior tube assembly. The interior tube of the coaxial system contains a central lumen to accommodate a 0.035" guidewire that exits near the tip of the delivery catheter. Radiopaque markers are located on the interior and exterior tubes to facilitate imaging during stent deployment. The device will be offered in 8mm & 10mm diameters and 100mm length.
The provided document, K030107, is a 510(k) summary for a medical device called the "100mm Wallstent™ RX Biliary Endoprosthesis." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information typically associated with acceptance criteria and a detailed study proving performance in the context of an AI-powered diagnostic device (as implied by many of your questions) is not present.
However, I can extract the relevant information from the document to address your points as much as possible within the context of a 510(k) for a stent.
Here's a breakdown based on your request, explaining why some fields are not applicable in this context:
1. Table of acceptance criteria and the reported device performance
For this 510(k), the acceptance criteria are not explicitly numerical performance metrics in the way one might expect for a diagnostic or AI device. Instead, the primary acceptance criterion is substantial equivalence to an existing predicate device. The performance data provided is related to bench testing, which supports this claim of equivalence.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Material Equivalence: Stent design and materials are identical to the predicate device. | "The stent design and materials are identical to the predicate Wallstent™ RX Biliary Endoprosthesis that is currently marketed by BSC for the same indication." |
| Intended Use Equivalence: The device has the same intended use as the predicate device. | "The proposed 100mm Wallstent™ RX Biliary Endoprosthesis is indicated for palliative treatment of biliary strictures produced by malignant neoplasms." (Same as predicate) |
| Technological Characteristics Equivalence: Performance through bench testing supports equivalence in critical technological characteristics. | "Bench testing was conducted to aid with the establishment of substantial equivalence of the proposed device to the predicate device." (No specific numerical results given in this summary) |
| Safety and Effectiveness: Demonstrate that the new device is as safe and effective as the predicate. | The FDA's letter of substantial equivalence confirms this finding, with specific labeling limitations added. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission relies on bench testing to demonstrate technological equivalence, not a "test set" of patient data for evaluating diagnostic performance.
- Data Provenance: Not applicable. Bench testing generally occurs in a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" to be established by experts in the context of this 510(k) submission for a stent. The evaluation is based on engineering specifications and bench testing.
4. Adjudication method for the test set
- Not applicable. There is no "test set" or adjudication process for diagnostic performance in this context.
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-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- Not applicable in the typical sense of diagnostic or AI ground truth (e.g., pathology, expert consensus). For a medical device like a stent, "ground truth" might more accurately refer to established engineering standards, material properties, and biological compatibility, which are assessed through bench testing and validated by comparison to the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth for it.
Summary of the Study (as described in the 510(k) documentation):
The "study" conducted for the 100mm Wallstent™ RX Biliary Endoprosthesis was bench testing. This testing was performed to establish substantial equivalence to the existing BSC Wallstent RX Biliary Endoprosthesis (K012752).
The key findings, as stated in the submission, are:
- The stent design and materials are identical to the predicate device.
- The intended use is the same: "palliative treatment of biliary strictures produced by malignant neoplasms."
- Bench testing supported the claim of substantial equivalence.
The FDA's decision to grant substantial equivalence (K030107) on March 21, 2003, indicates that based on the provided information, the device was deemed as safe and effective as the predicate, with specific labeling requirements related to a warning for vascular use and prominent display of its biliary indication.
§ 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.