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.

AI/ML Overview

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.

Summary

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K030107
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510(K) SUMMARY

1. Submitter:

Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

Contact: Jennifer Johnson Senior Regulatory Specialist Date Prepared: January 10, 2003

2. Device:

Trade Name: 100mm Wallstent™ RX Biliary Endoprosthesis Common Name: Biliary Stent Classification Name: Biliary Catheter & Accessories

3. Predicate Device:

BSC Wallstent RX Biliary Endoprosthesis - K012752

4. Device Description:

5. Intended Use:

The proposed 100mm Wallstent™ RX Biliary Endoprosthesis is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

6. Technological Characteristics:

The stent design and materials are identical to the predicate Wallstent™ RX Biliary Endoprosthesis that is currently marketed by BSC for the same indication.

7. Performance Data:

Bench testing was conducted to aid with the establishment of substantial equivalence of the proposed device to the predicate device.

Premarket Notification, 100mm Wallstent™ RX Biliary Endoprosthesis January 10, 2003 Proprietary and Confidential Information of Boston Scientific Corporation

MAR 2 1 2003

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K030107

Page 2 of 2

8. Conclusion:

BSC has demonstrated that the 100mm Wallstent™ RX Biliary Endoprosthesis is substantially equivalent to BSC's currently marketed Wallstent™ RX Biliary Endoprosthesis.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, conveying the department's mission of promoting health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2003

Ms. Jennifer Johnson Senior Regulatory Specialist Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760

Re: K030107

Trade/Device Name: Wallstent™ RX Biliary Endoprosthesis – 100 mm length Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: February 14, 2003 Received: February 19, 2003

Dear Ms. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found

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Page 2 – Ms. Jennifer Johnson

in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Daniel C. Schultz, M.D.

"Daniel G. Schultz, M.I Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K030107

Device Name: Wallstent™ RX Biliary Endoprosthesis -- 100 mm Length

FDA's Statement of the Indications For Use for device:

The Wallstent™ RX Biliary Endoprosthesis is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use_

David G. Hanson

Regulation Number and Section

§ 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.