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The HANAROSTENT® Esophagus Asymmetric (CCC) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.

This self-expanding tubular prosthesis is designed to maintain 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 delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire with fully covered silicone membrane, and 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 HANAROSTENT® Esophagus Asymmetric (CCC) is intended for single use only.

The provided document is a 510(k) summary for the HANAROSTENT® Esophagus Asymmetric (CCC), a device intended for maintaining esophageal luminal patency in esophageal strictures and occlusion of concurrent esophageal fistula. This type of device approval (510(k)) focuses on demonstrating substantial equivalence to a predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials as would be required for a Premarket Approval (PMA).

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the bench testing performed to demonstrate that the new device is substantially equivalent to existing, legally marketed devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a 510(k) device are generally established by comparison to a predicate device and relevant industry standards. For this device, the "acceptance criteria" are implied by the performance tests conducted, with the underlying assumption that the device's performance in these tests is comparable to or acceptable relative to the predicate device. The document does not explicitly state numerical acceptance criteria, but rather lists the types of tests performed to demonstrate substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No animal and clinical performance data is submitted in this 510(k)." The testing performed was "Bench testing." The sample sizes for each specific bench test (e.g., number of stents tested for foreshortening) are not specified in the provided text.

• Sample Size for Test Set: Not specified for individual bench tests.
• Data Provenance: The bench testing was performed by M.I.Tech Co., Ltd., which is based in the Republic of Korea. The testing is described as "performance testing was performed as per the design control system," suggesting it was conducted under controlled, in-house laboratory conditions (retrospective in the sense that the data already existed at the time of submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. For a 510(k) reliant on bench testing and substantial equivalence, there isn't a "ground truth" established by external medical experts in the same way there would be for a diagnostic AI study. The "ground truth" for the performance tests would be the established engineering specifications and the performance characteristics of the predicate device.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typical for clinical studies involving interpretation by multiple human readers, not for bench testing of medical devices. The "adjudication" for bench test results would be based on comparison to engineering specifications and predicate device data.

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

There was no MRMC comparative effectiveness study done. This study is for a physical medical device (esophageal stent), not an AI-assisted diagnostic tool.

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

There was no standalone (algorithm only) performance study done. This study is for a physical medical device (esophageal stent), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on the engineering specifications and performance characteristics derived from bench testing, as compared to the predicate device and relevant standards. It is not based on expert consensus, pathology, or outcomes data. The goal is to demonstrate that the new device performs comparably to the predicate device in key functional aspects.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" in the context of a 510(k) submission for a physical medical device like an esophageal stent. Training sets are relevant for machine learning or AI models.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the reasons stated above.

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