The Esophageal TTS Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a flexible, expandable tubular device made of Nitinol wire and are either fully silicone covered or partially silicone covered (the body is covered but both heads remains uncovered). This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.

AI/ML Overview

The provided text describes the regulatory clearance for the Esophageal TTS Stent but does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML or diagnostic performance metrics.

The document is a 510(k) summary for a medical device (an esophageal stent), which focuses on demonstrating substantial equivalence to a predicate device based on engineering and mechanical performance tests, rather than clinical efficacy studies with human subjects that would typically involve acceptance criteria for diagnostic accuracy, sensitivity, or specificity.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device evaluation (e.g., AI/ML-driven diagnostic tools).

Information Based on the Provided Text:

Here's what can be inferred or directly stated from the document, acknowledging that most of the requested fields are not applicable to this type of device clearance:

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Type of Test)	Reported Device Performance (Summary)
Expansion Force Testing	Demonstrated safety and effectiveness.
Compression Force Testing	Demonstrated safety and effectiveness.
Dimensional Testing	Demonstrated safety and effectiveness.
Deployment Testing	Demonstrated safety and effectiveness.
Deployment Force Testing	Demonstrated safety and effectiveness.
Tensile Strength Testing	Demonstrated safety and effectiveness.
Packaging Adhesive Strength Testing	Demonstrated safety and effectiveness.
MR Compatibility	Demonstrated safety and effectiveness.
Overall Conclusion	"The performance testing showed that the Esophageal TTS Stent with a larger body diameter of 20mm is as safe, as effective, and performs as well as or better than the predicate device."

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the document. The performance data section refers to engineering tests on the device, not a human reader or image-based test set.
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)
- This information is not provided and is not applicable to the type of device (a medical implant) and the type of testing described (engineering performance tests).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided and is not applicable to the type of testing described.
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
- No, an MRMC study was not done. This document describes the clearance of an esophageal stent, not an AI/ML diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable as the device is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the engineering performance tests would be the established engineering specifications and physical properties benchmarks. This is not explicitly detailed in the document beyond stating that "Performance Data" was collected per FDA "Guidance for Industry - Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses."
The sample size for the training set
- This is not applicable as the document describes the clearance of a physical medical device, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established
- This is not applicable as the document describes the clearance of a physical medical device.

Summary

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510(k) Summary

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Esophageal TTS Stent device is provided below.

Device Common Name:	Esophageal Prosthesis
Device Proprietary Name:	Esophageal TTS Stent
Submitter:	Y.J. KimTaewoong Medical Co., Ltd.1-5, Gomak-ri, Wolgot-myeon, Gimpo-si, Gyeonggi-do, Korea415871TEL: +82-31-996-0641FAX: +82-31-996-0645
Contact:	Calley HerzogConsultant, Medical DevicesBiologics Consulting Group, Inc.Phone: 720-883-3633Email: cherzog@bcg-usa.comFax: 720-293-0014
	OCT 0 9 2013
Date Summary Prepared:	October 10, 2012
Classification	21 CFR 878.3610
Regulation:
Panel:	General & Plastic Surgery Devices
Product Code:	ESW
Predicate Devices:	K113551 - Taewoong Esophageal TTS StentK080782 - Taewoong Niti-S Esophageal Stent

Indication for Use:

For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

Device Description:

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Comparison to the Predicates:

The Esophageal TTS Stent is substantially equivalent to the Esophageal TTS Stent cleared in K 113551 with the following exception: the submitted stent has a larger body diameter of 20mm. FDA has previously cleared a 20 mm diameter Esophageal stent with the same stent lengths as part of Taewoong's Niti-S stent system (K080782), so this new model does not raise any new types of safety and effectiveness questions.

The introducer used to deliver the Esophageal TTS Stent is the exact same introducer as the one cleared for use with the Esophageal TTS Stent (K113551). The matcrials, diameter, length and manufacturing are the same as previously cleared introducer.

Performance Data:

Per FDA "Guidance for Industry - Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses," the following tests were conducted:

Expansion Force Testing ●
Compression Force Testing .
Dimensional Testing 0
. Deployment Testing
Deployment Force Testing .
Tensile Strength Testing .

The following testing was also conducted:

. Packaging Adhesive Strength Testing
MR Compatibility .

The performance testing showed that the Esophageal TTS Stent with a larger body diameter of 20mm is as safe, as effective, and performs as well as or better than the predicate device.

Summary of Substantial Equivalence:

Based on the indications for use, technological characteristics and performance test results, the Esophageal TTS Stent is substantially equivalent to the predicate Esophageal TTS Stent.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle. The eagle is depicted in a simple, abstract style.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609. Silver Spring, MD 20993-0002

October 9, 2013

Taewoong Medical Co., Ltd. % Calley Herzog Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 Alexandria, VA 22314

Re: K123205

Trade/Device Name: Esophageal TTS Stent Regulation Number: 21 CFR$ 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: September 19, 2013 Received: September 23, 2013

Dear Calley Herzog,

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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. Please note: CDRFI does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Calley Herzog

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda,gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4.0 Indications for Use Statement

510(k) Number (if known): Kl23205

Device Name: Esophageal TTS Stent

Indications For Use:

For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2013.10.09 15:51:17 -04'00'

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Regulation Number and Section

§ 878.3610 Esophageal prosthesis.

(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”