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The HANAROSTENT® Esophagus (CCC) and HANAROSTENT® Esophagus (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 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 an over the wire (OTW) delivery device. 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 one repositioning lasso at each end of the stent made of polymeric materials. 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 (CCC) and the HANAROSTENT® Esophagus (NCN) are intended for single use only.

The provided text is a 510(k) summary for the HANAROSTENT® Esophagus (CCC) and HANAROSTENT® Esophagus (NCN) devices. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than presenting a clinical study with acceptance criteria for device performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement for a study proving device performance against acceptance criteria cannot be fully extracted from the provided text. The document explicitly states:

• "No animal performance data is submitted in this 510(k)."
• "No clinical performance data is submitted in this 510(k)."

Instead, the submission relies on bench testing to demonstrate performance and substantial equivalence.

Here's an analysis of what can be extracted or inferred based on the scope of the document:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way you've requested for a device proving study. It lists various bench tests performed and states:

• "Bench testing was performed to confirm the safety and effectiveness of the proposed subject devices as compared to the predicate devices."
• "Performance testing was performed as per the design control system."
• "The subject and predicate devices have equivalent expansion forces."
• "The subject and predicate devices have equivalent compression forces."
• "The subject delivery device in both 6mm (18Fr) and 8mm (24Fr) diameters have lower deployment forces than the predicate delivery device when deploying the HANAROSTENT® Esophagus (CCC)."
• "The subject delivery device in 6mm (18Fr) diameter has lower deployment force than the predicate delivery device when deploying the HANAROSTENT® Esophagus (NCN). The subject delivery device in 8mm (24Fr) diameter has equivalent deployment force to the predicate delivery device when deploying the HANAROSTENT® Esophagus (NCN)."

From this, we can infer that the acceptance criterion for many of these bench tests was "equivalence to the predicate device" or "lower than the predicate device" (for deployment force, which is a positive outcome). However, specific numerical acceptance thresholds or detailed performance metrics are not provided.

Inferred Table of Performance and Criteria (Based on Bench Testing for Substantial Equivalence):

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

The document does not specify sample sizes used for the bench tests. Since no clinical data was submitted, there is no "test set" in the context of patient data. The bench tests were presumably conducted internally by M.I.Tech Co., Ltd., based in the Republic of Korea. Therefore, the data provenance for these bench tests would be the Republic of Korea. It's not applicable to categorize bench testing as retrospective or prospective.

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. The submission relies entirely on bench testing for substantial equivalence, not on a clinical test set requiring expert interpretation or ground truth establishment in a medical context.

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

Not applicable, as there is no clinical test set requiring adjudication.

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/software device and no MRMC study was conducted.

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

Not applicable. This is a medical device (stent and delivery system), not an algorithm.

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

Not applicable. For the bench tests, the "ground truth" would be the engineering specifications and established standards for material and device performance, against which the physical properties of the stent were tested.

8. The sample size for the training set

Not applicable, as no clinical study (and thus no training set) was conducted or submitted.

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

Not applicable, as there is no training set.

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