The LifeStent SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with expanded diameters of 6.0, 7.0, and 8.0 mm at stent lengths of 18, 26, 36, and 56 mm.

AI/ML Overview

The provided text describes a 510(k) submission for the "LifeStent SDS Biliary Endoprosthesis." This is a medical device submission seeking clearance to market, demonstrating substantial equivalence to existing devices. It is not a study that proves the device meets acceptance criteria in the way described by the request, particularly for AI/machine learning models.

The information provided focuses on comparative technological characteristics (materials, performance properties, biocompatibility, sterilization, packaging) and in vitro tests to establish substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria for device performance based on patient outcomes or expert evaluations.

Therefore, many of the requested fields cannot be directly answered from the provided document.

Here's a breakdown of what can be inferred or directly stated, and what cannot:

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

The document does not specify quantitative acceptance criteria with corresponding performance results. Instead, it states: "Orbus protocols ensure that the LifeStent SDS Biliary Endoprosthesis performs in a manner substantially equivalent to the predicate devices during in vitro tests such as deployment, expansion force, compression force, dimensions, corrosion susceptibility, visual appearance, balloon performance, expansion damage, and balloon tensile strength." This implies that the device met internal performance specifications designed to demonstrate equivalence, but the specific metrics and targets are not disclosed.

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

Not applicable. This was an in vitro (laboratory) testing comparison against predicate devices, not a clinical study involving a test set of patient data.

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. Ground truth for clinical data is not relevant to this in vitro device comparison.

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

Not applicable.

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 diagnostic device, nor was an MRMC study described.

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

Not applicable. This is not an algorithm.

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

For the in vitro tests, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices and the physical measurements/observations during testing of the LifeStent SDS Biliary Endoprosthesis. This is not clinical ground truth.

8. The sample size for the training set

Not applicable. No training set is mentioned as this device clearance is not based on a machine learning model.

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

Not applicable.

Summary of what can be extracted based on the nature of the submission:

Device Type: Biliary stent (LifeStent SDS Biliary Endoprosthesis) mounted on a balloon catheter.
Intended Use: Palliation of malignant neoplasms in the biliary tree.
Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
Performance Evaluation: Primarily in vitro testing.
Comparison Basis: Substantial equivalence to predicate devices based on:
- Identical intended use.
- Identical material properties.
- Similar performance properties (deployment, expansion force, compression force, dimensions, corrosion susceptibility, visual appearance, balloon performance, expansion damage, balloon tensile strength).
- Similar packaging and sterilization methods.
Key Finding: The device was deemed substantially equivalent to predicate devices, allowing it to be marketed.

Conclusion: The provided document is a 510(k) clearance letter and associated summary information. It describes regulatory clearance based on substantial equivalence demonstrated through in vitro testing, not a clinical study with detailed acceptance criteria and performance data as would be typically expected for AI/ML device validation or a human clinical trial. As such, the specific metrics for patient-centric acceptance criteria, sample sizes for medical data, and expert ground truth establishment are not present in this document.

Summary

{0}------------------------------------------------

K023308
page 1 of 2

510(k) Statement

1.	Submitter:	Orbus Medical Technologies, Inc5363 NW 35th AveFort Lauderdale, Florida 33309Phone: (954) 730-0711Fax: (954) 730-7601
2.	Contact:	Jim ClossickDirector of Quality Assurance and Regulatory Affairs
3.	Date Prepared:	October 2, 2002
4.	Device Trade Name:	LifeStent SDS Biliary Endoprosthesis
5.	Device Common Name:	Biliary stent
6.	Device Classification:	Biliary Catheter (78 FGE)
7.	Predicate Devices:	IntraStent DoubleStrut ParaMount XS Biliary EndoprosthesisPALMAZ CORINTHIAN Transhepatic Biliary Stent and DeliverySystemOTW MEGALINK SDS Biliary Stent SystemPALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018"Delivery System

8. Description:

9. Intended Use:

The LifeStent SDS Biliary Endoprosthesis is intended for the palliation of malignant neoplasms in the biliary tree.

10. Technological Characteristics:

Comparisons of the new and predicate devices were designed to show that the technical characteristics such as materials, performance properties, biocompatibility, method of sterilization, and packaging are identical or substantially equivalent.

11. Performance Data:

Orbus protocols ensure that the LifeStent SDS Biliary Endoprosthesis performs in a manner substantially equivalent to the predicate devices during in vitro tests such as deployment, expansion force, compression force, dimensions, corrosion susceptibility, visual appearance, balloon performance, expansion damage, and balloon tensile strength.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the text "K023308 page 2 of 2". The text is written in a simple, handwritten style. The words "page" and "of" are written in lowercase letters, while the numbers are written in standard numerical format. The text appears to be a page number or document identifier.

12. Conclusion

Since the LifeStent SDS Biliary Endoprosthesis, comprised of the Ø 6-10 mm LifeStent (K010107) and the Opti-Plast XT catheter (K941706), has the same intended use, identical material properties, similar performance properties, packaging, and sterilization methods, it may be considered substantially equivalent to the predicate devices cited in (7).

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 2:0850

APR 1 4 2003

Mr. Jim Clossick Director of Quality Assurance and Regulatory Affairs Orbus Medical Technologies 5363 NW 35" Avenue FT LAUDERDALE FL 33309

Re: K023308

Trade/Device Name: Orbus LifeStent SDS Biliary Endoprosthesis Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 18, 2003 Received: March 19, 2003

Dear Mr. Clossick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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.

{3}------------------------------------------------

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 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 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. 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), please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known): K023308

Device Name: Orbus LifeStent SDS Biliary Endoprosthesis

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

The Orbus LifeStent SDS Biliary Endoprosthesis is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

Daniel A. Legum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .

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.