The Abbott Vascular Devices Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is comprised of a delivery system and a self-expanding stent. The delivery system is an over the wire (OTW) system designed to deliver the self-expanding stent to the biliary tree.

AI/ML Overview

This document is a 510(k) summary for the Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System. It is a premarket notification for a medical device seeking clearance from the FDA.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to performance metrics like accuracy, sensitivity, or specificity.

Here's a breakdown of why and what information is available:

1. A table of acceptance criteria and the reported device performance:

Not Applicable. The document is a 510(k) premarket notification for a medical device (a stent and its delivery system), not an AI/algorithm-driven device. As such, it does not typically involve acceptance criteria related to performance metrics like those for AI. The "performance" assessment for a stent primarily revolves around non-clinical testing (material properties, mechanical integrity, deployment success, etc.) and clinical safety and effectiveness in its intended use.
The document states: "Substantial equivalence was confirmed through non-clinical testing." This refers to a comparison with a legally marketed predicate device (K050103) based on design characteristics, materials, and non-clinical performance (e.g., bench testing) to demonstrate that the new device is as safe and effective as the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not Applicable. This information is relevant for studies involving data analysis (like AI/ML performance). For a stent 510(k), non-clinical testing involves bench tests and potentially animal studies, not typically "test sets" of patient data in the AI sense. Clinical data, if submitted, would be described in terms of patient cohorts. However, this 510(k) specifically only mentions "non-clinical testing" for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not Applicable. No ground truth establishment by experts for a "test set" is mentioned, as this is not an AI/algorithm device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. No adjudication method is described, as there's no "test set" in the context of an AI/ML algorithm requiring expert adjudication of results.

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-assisted device. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted or reported.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical medical device (stent), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. As mentioned, this is not an AI/ML device requiring ground truth for data analysis. The "truth" for a stent's performance is typically assessed through its mechanical properties, biocompatibility, and clinical outcomes for safety and effectiveness in its intended use. The 510(k) relies on showing substantial equivalence to a predicate device, meaning its characteristics and expected performance are similar enough to the device already on the market.

8. The sample size for the training set:

Not Applicable. This information pertains to machine learning models, which are not relevant to this device.

9. How the ground truth for the training set was established:

Not Applicable. As above, this is not a machine learning device.

In summary: The provided document is a 510(k) summary for a physical medical device (a stent), not an AI/ML device. Therefore, the questions related to acceptance criteria, test sets, ground truth establishment, and AI performance metrics are not applicable to the information contained within this specific regulatory submission. The device received 510(k) clearance based on "non-clinical testing" demonstrating "substantial equivalence" to a predicate device.

Summary

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APPENDIX A. 510(k) SUMMARY

Sponsor/Submitter:	Abbott LaboratoriesAbbott Vascular Devices400 Saginaw DriveRedwood City, CA 94063
Contact Person:	Ann E. LeonardRegulatory Affairs CoordinatorPhone:(650) 474-3477Fax:(650) 474-3041
Date of Submission:	February 25, 2005MAR 1 4 2005
Device Trade Name:	Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System
Device Common Name:	Biliary Stent and Delivery System
Device Classification:	Class II
Regulation Number:	21 CFR 876.5010
Classification Name:	Biliary Catheter and Accessories
Product Code:	78 FGE
Predicate Device:	Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System(K050103)
Intended Use:	The Xceed Nitinol Self-Expanding Transhepatic Biliary StentSystem is intended for use in the palliation of malignant neoplasmsin the biliary tree.
Device Description:	The Abbott Vascular Devices Xceed Nitinol Self-ExpandingTranshepatic Biliary Stent System is comprised of a delivery systemand a self-expanding stent. The delivery system is an over the wire(OTW) system designed to deliver the self-expanding stent to thebiliary tree.
Summary of SubstantialEquivalence:	The Xceed Nitinol Self-Expanding Transhepatic Biliary StentSystem is substantially equivalent to the predicate device.Substantial equivalence was confirmed through non-clinical testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2005

Ann E. Leonard, Ph.D. Regulatory Affairs Coordinator Abbott Vascular Devices 400 Saginaw Drive REDWOOD CITY CA 94063

Re: K050501

KU50301
Trade/Device Name: Xceed™ Nitinol Self-Expanding Transhepatic Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: February 25, 2005 Reccived: February 28, 2005

Dear Dr. Leonard:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revewed your section 510(x) premained is substantially equivalent (for the indications for referenced above and nave actemined and as a so a set a sevices marketed in interstate commerce use stated in the encrosure/ to regally manythe Medical Device Amendments, or to devices that prior to May 26, 1770, the ondemont adts the provisions of the Federal Food, Drug, and Cosmetic nave been reclassified in accordants that e device, subject to the general controls provisions of the Act (Act). Tou may, mercerors, markew. The general controls provisions of the Act include Act and the infridations desorroed betwn - 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 I fie Office of De vice Evaranton has deterfied in the proposed labeling and that such use could cause will be used for an intended ass not resmaion 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 runnermore, the marculen for of estructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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Page 2 - Dr. Ann Leonard

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to additional controls. Existing major regulations affecting your device can be found may be subject to additions. Exismigations Existing major organism FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination doest not mean that Please be advised that IDA's Issualled of a sace annolies with other requirements of the Act of any FDA has made a determination that your der Federal agencies. You must comply with all
Federal statutes and regulations administered by other Federal (21 GED B. 4807) Federal statutes and regulations dammisted to: registration and listing (21 CFR Part 807); the Act s requirements, mending, but not mined to: 10 reguirements as set forth in the quality labeling (21 CFR Part 801), good manataling problicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product Systems (QD) regulation (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 The FDA Inding Of substantar equivalence or your device to proceed to the market. This results in a classification for your device and permise your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Please note that the above labeling immations 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 If you desire specific information association as appliance at (301) 594-4616. Also, please note (21 CFR Fart 6017), prease contact ins Officence to premarket notification'' (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division I ou may obtain other general ational, 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,

jQeGTn

Jonna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K050501

Device Name: Abbott Vascular Devices™ Xceed™ Nitinol Self-Expanding Transhepatic Biliary Stent System

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

The Abbott Vascular Devices™ Xceed™ Nitinol Self-Expanding Transhepatic Biliary Stent System I he Abbott vascular Doviees
is intended for use in the palliation of malignant neoplasms in the biliary tree.

Prescription Use (Pcr 21 CFR 801.109) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

) Nancy Hogdon
(Division Sign-Off)

Oivision of Reproductive, Abdom ind Radiological Devices 10(k) Number_ 05091

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.