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The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT® Esophagus TTS (NCN) are intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

This self-expanding tubular prosthesis is designed to maintain esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and a through-the scope delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, radiopaque markers made of gold wire, fully or partially covered silicone membrane, and repositioning lasso made of polyester. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. The delivery system is compatible with a minimum 3.7mm working channel of a therapeutic endoscope. The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT® Esophagus TTS (NCN) are intended for single use only.

This document describes the FDA 510(k) premarket notification for the HANAROSTENT Esophagus TTS (CCC) and HANAROSTENT Esophagus TTS (NCN) devices. This is a medical device, specifically an esophageal prosthesis, and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing clinical performance data from studies involving AI or complex data analysis.

Therefore, many of the requested items (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, effect size of human reader improvement with AI) are not applicable to this type of device submission. The information provided is primarily related to bench testing (physical and mechanical properties) to prove equivalence.

Here's a breakdown of the relevant information provided in the document based on your request:

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

The document describes bench testing to demonstrate similarity to the predicate device. It doesn't explicitly state "acceptance criteria" in a numerical table form for each test, but it indicates that the subject devices "have equivalent" or "greater" performance in certain aspects compared to the predicate device. The underlying acceptance criterion for these tests would be "equivalent performance to the predicate device" or "acceptable performance within a given range" determined by the manufacturer and accepted by the FDA for substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Test set sample size: Not explicitly stated. The "test set" here refers to the samples of the HANAROSTENT device used for bench testing. The testing would have involved a number of manufactured units, but the specific count is not provided.
• Data provenance: The bench testing was performed by the manufacturer, M.I. Tech Co., Ltd., which is based in South Korea. The data is from prospective testing of newly manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device relies on pre-clinical bench testing (mechanical and material properties) and substantial equivalence to a predicate device. There is no "ground truth" derived from expert interpretation of medical images or clinical outcomes in this submission.

4. Adjudication method for the test set:

• Not applicable. As there are no human interpretations or clinical outcomes requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (stent) and relies on bench testing and substantial equivalence.

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

• Not applicable. This is not an AI/algorithm-based device. It is a physical medical implant.

7. The type of ground truth used:

• The "ground truth" for this submission comes from bench testing specifications, engineering principles, and comparison to the known performance of the predicate device. For example, the "ground truth" for expansion force is a measurable mechanical property verified against engineering standards and the predicate device's performance. There is no clinical "ground truth" (e.g., pathology, clinical outcomes, expert consensus) presented in this 510(k) summary.

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. There is no training set for this device.

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