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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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The Ultraflex™ Esophageal NG Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and, for occlusion of concurrent esophageal fistula (for covered stents only).

The Ultraflex™ Esophageal NG Stent System (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.

The Covered Ultraflex™ Esophageal NG Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.

The proposed Ultraflex™ Esophageal NG Stent System consists of a self-expanding metal stent preloaded on a flexible delivery catheter. The stent is offered either bare or covered and with either a proximal release or distal release delivery system.

The stent may be placed flouroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. To deploy the stent, hold the handle hub in the palm of one hand, and grasp the finger ring with the other hand. As the finger ring is retracted, the suture crochet knots are unraveled in a circular manner along the length of the stent, gradually deploying the stent. When the stent is completely released, the delivery catheter is removed.

This section describes the performance data and acceptance criteria for the Ultraflex™ Esophageal NG Stent System.

1. Acceptance Criteria and Reported Device Performance:

• A modified crochet suture pattern on the delivery catheter to create a 10mm "visual marker" (for proximal release product codes only).
• Modified suture material threaded around the circumference of each stent end. |
  | Impact on Device Performance | These modifications have not impacted the device performance as demonstrated by bench testing. |

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

• Sample Size: Not explicitly stated as a numerical value for a "test set" in the context of clinical data. The performance was demonstrated through "bench testing."
• Data Provenance: The document implies that the "bench testing" was conducted internally by Boston Scientific Corporation. The data provenance is presumed to be internal laboratory testing rather than human subject data with country of origin.

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

• Not applicable. The "ground truth" for this submission was based on engineering bench testing, not expert clinical interpretation of data.

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

• Not applicable. No clinical adjudication method was used for this bench testing.

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 submission pertains to a medical device (stent system) and its mechanical performance, not an AI or imaging diagnostic tool that would involve human readers.

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

• Not applicable. This device is not an algorithm. Bench testing was performed on the device itself.

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

• The "ground truth" was established through bench testing to assess the mechanical and functional characteristics of the device, primarily focused on ensuring that the stated modifications did not negatively impact performance compared to the predicate device. This would likely involve measurements of physical properties, deployment mechanics, and other relevant engineering parameters.

8. The sample size for the training set:

• Not applicable. This submission describes bench testing for a physical device, not an AI model that requires a training set.

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

• Not applicable. No training set was used.

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