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The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

This self-expanding tubular prosthesis designed to maintain patency of colorectal obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire and the delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system. The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is intended for single use only.

The HANAROSTENT® LowAxTM Colon/Rectum (NNN) device is a self-expanding tubular prosthesis designed to maintain the patency of colorectal obstructions caused by malignant tumors. This device is an update to a previously cleared device (K183616) with the only difference being the inclusion of a 25mm diameter stent.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) submission for a device that is nearly identical to a previously cleared predicate (K183616), the acceptance criteria primarily focus on demonstrating that the expanded stent diameter range (to include 25mm) does not negatively impact the device's safety and effectiveness. The acceptance criteria and performance are derived from the existing predicate device and new bench testing for the expanded size.

• Axial force
• Compression force
• Deployment force
• Deployment accuracy
• Dimensions
• Expansion force
• Repositioning force
• Stent separation
• Tensile strength
• Trackability | M.I. Tech performed new bench testing to support the subject device in these areas.
  The submission states these tests were performed and results support safety and effectiveness. (Specific values not provided in document) | New testing specifically conducted for the expanded 25mm diameter stent. |
  | Corrosion Resistance | Meet established standards for corrosion (same as predicate K183616) | Testing provided with K183616 leveraged. | No new corrosion testing was required as the material is unchanged. |
  | MR Compatibility | Meet established standards for MR compatibility (same as predicate K183616) | Testing provided with K183616 leveraged. | No new MR compatibility testing required. |
  | Packaging Validation (for new 25mm stent) | Meet established standards for:
• Dye penetration
• Seal strength
• Sterility | M.I. Tech performed new packaging validation testing to support the subject device in these areas. (Specific values not provided in document) | New packaging validation specific to the updated device configuration. |

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

The document does not specify a "test set" in the context of clinical data or patient outcomes for this particular submission. The evaluation is primarily based on bench testing for the new 25mm stent diameter. The document states:

• "M.I. Tech performed new bench testing to support the subject device."
• "M.I. Tech performed new packaging validation testing to support the subject device."

The specific sample sizes for these bench tests (e.g., number of stents tested for axial force, compression force, etc.) are not provided in this summary. The provenance of this bench testing data would be from the manufacturer, M.I. Tech Co., Ltd., based in the Republic of Korea. It is lab-based, not patient-derived, and is considered prospective with respect to the design modifications.

The submission is a Special 510(k) which relies heavily on the substantial equivalence to a predicate device (K183616). Therefore, much of the underlying data and validation for the core device characteristics would have been part of the K183616 submission.

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

This information is not applicable and not provided in the document. The evaluation is focused on engineering and performance bench testing against established standards, not clinical ground truth established by medical experts for a diagnostic or predictive device. For device safety and performance evaluation, relevant engineers and quality control personnel within M.I. Tech would have performed and reviewed the bench testing.

4. Adjudication method for the test set

This information is not applicable and not provided in the document. Adjudication methods (e.g., 2+1, 3+1) refer to clinical judgment by multiple experts to establish ground truth, typically for diagnostic studies. The testing described here is bench testing against specified engineering parameters.

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 device is a medical implant (stent) and not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are not relevant.

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

This information is not applicable. The device is a physical medical device (stent), not an algorithm or software. Therefore, standalone performance of an algorithm is not a relevant concept for this submission.

7. The type of ground truth used

The "ground truth" for this submission is established through engineering standards and specifications for physical device performance. The bench testing performed for the 25mm diameter stent confirms that it meets these predefined performance criteria (e.g., axial force, compression force, deployment accuracy, dimensions). For the characteristics leveraged from the predicate device, the ground truth was established through similar engineering tests and potentially clinical data submitted with K183616.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML device that requires a training set. The "training set" concept is relevant for machine learning models, not for physical medical device engineering validation.

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

This information is not applicable. As stated above, this device does not utilize a training set in the context of AI/ML.

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The HANAROSTENT LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in palignant structures.

The HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.

This self-expanding tubular prosthesis designed to maintain patency of colorectal or duodenal obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire and the delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system. The HANAROSTENT® LowAx™ Colon/Rectum (NNN) and HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) are intended for single use only.

This document (a 510(k) summary) describes a submission for a medical device re-clearance rather than a de novo submission. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K180180), not to prove de novo clinical efficacy or safety of a fundamentally new device through extensive clinical trials.

Therefore, the typical components of acceptance criteria and the detailed study proving the device meets those criteria (especially regarding human-in-the-loop AI performance, ground truth establishment for large datasets, etc.) are not present in this type of regulatory document. The focus shifts to demonstrating that the new version of the device is essentially the same as the previously cleared version, with any minor changes like MR compatibility testing still ensuring safety and effectiveness.

Here's a breakdown based on the provided text, explaining why certain requested information is absent or not applicable:

Key Takeaway: The device in question (HANAROSTENT LowAx™ Colon/Rectum and Duodenum/Pylorus) is a self-expanding metal stent. Its performance is assessed through bench testing (physical and material properties) and by demonstrating identical characteristics to a previously cleared device, not through studies involving AI, human reader improvement, or large-scale clinical outcomes data in the way a diagnostic AI device would be.

Acceptance Criteria and Device Performance (Based on "Substantial Equivalence" and "Performance Testing" sections):

This submission leverages the substantial equivalence pathway. The primary "acceptance criteria" are demonstrating that the subject device is identical or nearly identical to its predicate device (K180180) in critical aspects, and that any small change (MR compatibility) does not compromise safety or effectiveness.

Here's a table reflecting what is implicitly stated as "met" by virtue of substantial equivalence and new testing:

Regarding the Absence of Specific Study Details (as related to AI/Diagnostic Devices):

This submission is for a medical device (physical stent), not a diagnostic algorithm or AI software for image analysis. Therefore, many of the requested details related to AI study design are not applicable or not part of this type of submission.

1. Sample sizes used for the test set and data provenance:

   • N/A (for AI/diagnostic data). This device is a physical stent. Performance testing involves bench tests (e.g., force measurements, corrosion) on device samples, not patient data sets or images. The "test set" in this context refers to the physical devices or components tested. There are no "patients" or "data" in the sense of a diagnostic study.

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

   • N/A. Ground truth for a physical stent is established by engineering specifications, material science, and established test methods (e.g., ASTM standards for mechanical properties). No human experts are adjudicating "ground truth" on images or clinical outcomes for this device in this submission.

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

   • N/A. Applies to human reading/AI performance studies, not physical device testing.

4. 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:

   • N/A. This device does not involve human readers, AI assistance, or image interpretation.

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

   • N/A. This is not an algorithm or AI device. Its "standalone performance" refers to its physical characteristics and functionality as a stand-alone stent and delivery system, assessed via bench tests.

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

   • For the physical properties: Engineering specifications, established test methods (e.g., ISO, ASTM standards), and material science principles.
   • For comparison to the predicate: The previously cleared predicate device (K180180) itself serves as the "ground truth" for substantial equivalence regarding its established safety and effectiveness.

7. The sample size for the training set:

   • N/A. This is not an AI/machine learning device that requires a "training set."

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

   • N/A. No training set is involved.

In summary, this 510(k) submission leverages the "Substantial Equivalence" pathway for a physical medical device. The "study that proves the device meets the acceptance criteria" primarily consists of:

• A detailed comparison demonstrating identical technological characteristics to a previously cleared predicate device (K180180).
• Reliance on the performance testing data submitted for that predicate device.
• New bench testing specifically for MR compatibility to support new labeling.

The document explicitly states: "The subject device in this Traditional 510(k) submission is the exact same, identical device as predicate device K180180." This claim, supported by the comparison of characteristics and leveraging prior testing, is the core of demonstrating it meets the implicit "acceptance criteria" for clearance via substantial equivalence.

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