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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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HANAROSTENT® Esophagus (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.

HANAROSTENT® Esophagus (CCC) is a self-expanding polygon mesh surface, tubular prosthesis designed to maintain patency of esophageal strictures caused by malionant tumors. The stent is made of Nitinol wire (hook and cross wire structure) and a silicon membrane designed in such a way as to prevent migration and tumor in-growth. The stent is symmetrical in shape, with the diameter of both ends of the stent extending beyond the diameter of the stent body (larger banded flanges). This band design has become standard practice and aids in preventing stent migration.

Based on the provided text, the device in question, HANAROSTENT® Esophagus (CCC), is a medical device, specifically an esophageal stent, and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "device performance" in the context of AI models (e.g., accuracy, sensitivity, specificity) and human reader studies (MRMC) does not directly apply here.

The document describes a 510(k) submission for substantial equivalence to predicate devices, focusing on physical and mechanical properties, as well as intended use.

However, I can extract information related to the device's technical specifications and compare them to predicate devices, which serves as the basis for its "acceptance" by the FDA as substantially equivalent.

Here's an interpretation based on the provided text, framed to align as closely as possible with your request, even though it's a medical device rather than an AI system:

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

The "acceptance criteria" for a 510(k) submission for a non-AI medical device like this are generally demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing intended use, technological characteristics, and performance data to ensure no new safety or effectiveness concerns are raised.

In this case, the reported "device performance" is a comparison of key physical and mechanical properties to predicate devices. The "acceptance criteria" are implied to be that these characteristics are similar enough to not introduce new risks.

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

The document states "The results of bench and test laboratory testing indicate that the new device is as safe and effective as the predicate devices." and mentions "analyzing both bench as well as laboratory testing to applicable standards".

• Sample size for test set: Not explicitly stated. The testing appears to be on the physical device itself (material, mechanical properties, etc.), not a clinical "test set" of patients.
• Data provenance: Not explicitly stated. It's bench and laboratory testing, likely conducted by the manufacturer, M. I. Tech Co., Ltd. (Korea), given their address is provided.
• Retrospective or prospective: Not applicable as it's bench/lab testing, not a clinical study.

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)

This is not applicable as the study involves bench and laboratory testing of a physical medical device's properties, not the evaluation of a diagnostic or predictive algorithm. There isn't a "ground truth" to be established by medical experts in this context.

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

Not applicable. There's no adjudication method in the context of physical property testing for substantial equivalence.

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 a physical medical device (esophageal stent), not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improve with AI" are irrelevant to this submission.

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

Not applicable. There is no algorithm or AI component in this device.

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

For the bench and laboratory testing, the "ground truth" would be established by validated scientific methods and accepted engineering standards for measuring physical and mechanical properties (e.g., using calibrated instruments to measure force, diameter, corrosion resistance). It's not a clinical "ground truth."

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, there is no training set for a traditional medical device like this.

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