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The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

The Esophageal TTS Stents consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency.

The provided document is a 510(k) premarket notification for the Taewoong Medical Co., Ltd. Esophageal TTS Stent. It states that the device is "substantially equivalent" to previously cleared predicate devices (K211706, K123205, K113551) with the "exception of a modification to the Indications for Use statement."

As such, this document does not contain acceptance criteria for this specific submission with new performance data to prove the device meets these criteria. Instead, it relies on the previous clearances and argues that the change in indication does not affect safety and efficacy, therefore no additional performance data is required for this 510(k).

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from this document. The document explicitly states:

• No additional biocompatibility information is required.
• Not applicable for Electrical safety and electromagnetic compatibility (EMC) as it contains no electrical components.
• Not applicable for Software Verification and Validation Testing as it contains no software.
• No additional performance data is required for Bench Testing because no design modifications were made.
• Not applicable for Animal Testing.
• Not applicable for Clinical Data.

The 510(k) submission relies on the substantial equivalence principle, asserting that since the new device is identical in design and materials to previously cleared devices, and the change in indication does not introduce new risks, the prior performance data of the predicate devices is sufficient.

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