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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 HANAROSTENT® Benefit™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.

The HANAROSTENT® Benefit™ Biliary (NNN) is a self-expanding tubular prosthesis designed to maintain patency of biliary obstructions caused by malignant tumors. 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. 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 stent and delivery device are provided sterile and are intended for single use only.

The provided document describes the HANAROSTENT® Benefit™ Biliary (NNN), a self-expanding tubular prosthesis intended for the palliation of malignant strictures in the biliary tree. The submission is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through extensive clinical trials.

Therefore, the acceptance criteria and study information provided in this document are focused on demonstrating this substantial equivalence through a combination of bench testing and comparison of technological characteristics with predicate and reference devices, rather than a clinical study evaluating the device's performance against specific clinical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state quantitative acceptance criteria for device performance based on a clinical study or specify performance metrics for a diagnostic device. However, it implicitly uses the performance of the predicate device as the "acceptance criteria" through a direct comparison of technological characteristics and bench testing results. The goal is to demonstrate that the new device is as safe and effective as the predicate.

   Performance Metric (Implied Acceptance Criteria)	Reported Device Performance
   Design Verification Testing:
   Foreshortening	Confirmed safety and effectiveness (as compared to predicate device)
   Crossing Profile	Confirmed safety and effectiveness (as compared to predicate device)
   Trackability	Confirmed safety and effectiveness (as compared to predicate device)
   Deployment Force	Equivalent to predicate device (Technological Characteristics section) and confirmed safety and effectiveness (Bench Testing section)
   Withdrawal (Repositioning) Force	Confirmed safety and effectiveness (as compared to predicate device)
   Expansion Force	Equivalent to predicate device (Technological Characteristics section) and confirmed safety and effectiveness (Bench Testing section)
   Stent Separation	Confirmed safety and effectiveness (as compared to predicate device)
   Deployment Accuracy	Confirmed safety and effectiveness (as compared to predicate device)
   Compression Force	Equivalent to predicate device (Technological Characteristics section) and confirmed safety and effectiveness (Bench Testing section)
   Stent Integrity	Confirmed safety and effectiveness (as compared to predicate device)
   Stent Dimensional Verification	Confirmed safety and effectiveness (as compared to predicate device)
   Delivery System Tensile Strength	Confirmed safety and effectiveness (as compared to predicate device)
   Biocompatibility Testing:	Confirmed safety and effectiveness (as compared to predicate device)
   MRI Safety and Compatibility Testing:	Confirmed safety and effectiveness (as compared to predicate device)
   Corrosion Testing:
   Single stent	Equivalent simulated single stent implant corrosion susceptibility to predicate device
   Overlapping stents (stent-in-stent)	Equivalent simulated stent-in-stent implant corrosion susceptibility to reference devices

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

   • The document states that "Bench testing was performed... as per the design control system." It does not specify the exact sample sizes (number of units tested) for each of the bench tests listed (e.g., foreshortening, deployment force).
   • Data Provenance: The bench testing was performed internally by the manufacturer, M.I.Tech Co., Ltd., based in the Republic of Korea. All data is presumably prospective as it was generated specifically for this 510(k) submission.

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

   Not applicable. This submission relies on bench testing and comparison to predicate devices, not on a clinical test set requiring expert ground truth for interpretation of outcomes.

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

   Not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.

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. The HANAROSTENT® Benefit™ Biliary (NNN) is a physical medical device (stent), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant to this submission.

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

   Not applicable. This is a physical medical device, not an algorithm.

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

   For the purposes of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily established by:

   • Predicate device characteristics and performance: The established safety and effectiveness of the legally marketed predicate device (HANAROSTENT® Biliary (NNN), K111149).
   • Engineering specifications and regulatory standards: Adherence to defined engineering specifications and relevant FDA guidance documents and international standards (e.g., ISO 10993-1 for biocompatibility, guidance for Nitinol devices, MRI safety).
   • Bench test results: Quantitative measurements obtained from various physical and mechanical tests directly on the device.

8. The sample size for the training set:

   Not applicable. There is no "training set" in the context of a physical device like a stent. The device design and materials are based on established engineering principles and prior device iterations (like the predicate device), not machine learning.

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

   Not applicable, as there is no training set.

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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® FAST™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.

This self-expanding tubular prosthesis is designed to maintain patency of bile duct 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, and expanded in the body by pulling the outer sheath of the delivery system. The HANAROSTENT® FAST™ Biliary (NNN) is intended for single use only.

The provided document is a 510(k) Pre-Market Notification for a medical device called the HANAROSTENT® FAST™ Biliary (NNN). This notification primarily focuses on demonstrating substantial equivalence to a predicate device (HANAROSTENT® Biliary (NNN), K111149) rather than presenting a de novo study with explicit acceptance criteria and device performance for a new, unproven device.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for a clinical study to prove device performance in terms of patient outcomes. Instead, it describes bench testing to confirm the safety and effectiveness of the device compared to a predicate, focusing on technical characteristics and design changes.

The "reported device performance" is essentially that the device performed comparably to the predicate in these bench tests and that the modifications did not raise new safety or effectiveness issues.

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

The document explicitly states that "Appropriate bench testing was performed" and refers to "non-clinical data." This indicates that no human test set (patients) was used for this 510(k) submission. The testing was performed on physical device samples. The number of samples for each specific bench test is not provided.

• Sample size for test set: Not specified numerically for individual tests, but refers to physical device samples for bench testing. No human test set was used.
• Data provenance: Bench testing results, likely conducted in-house or by a contracted lab. No country of origin for human data, as no human data was used. The study is not applicable for retrospective or prospective classification as it involves bench testing, not clinical data.

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

Not applicable. There was no human "test set" and therefore no ground truth established by medical experts in the context of this 510(k) submission. The ground truth for bench testing is determined by engineering specifications and physical measurements.

4. Adjudication Method for the Test Set

Not applicable. As no human test set was used, there was no need for expert 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 510(k) pertains to a physical medical device (stent), not a medical imaging AI algorithm. Therefore, an MRMC study or assessment of AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission was based on engineering specifications, physical measurements, and comparison to the predicate device's established performance. The core argument is substantial equivalence, meaning the new device performs similarly to a legally marketed device that has already been deemed safe and effective.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm, so there is no "training set."

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

Not applicable. This is not an AI algorithm.

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HANAROCare ReJu is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

HANAROCare ReJu is a personal stimulator that reduces the pain by delivering a specific rhythmic electric stimulation to the nerves and the muscles through electrode attached to the skin (Transcutaneous Electrical Nerve Stimulation). Electric current delivered to the nerves reduces the pain. The subject device offers four different stimulation modes (Mode 1, Mode 2, Mode 3, and Combination Mode). It is composed of as stimulator, silicon electrode, and gel pads.

The provided text describes the Hanarocare Reju, a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria for device performance in a clinical study specifically, nor a study proving it meets such criteria in terms of efficacy on patients.

The "Performance Data" section details various engineering, electrical, biocompatibility, and usability tests, but these are about the device's technical specifications, safety, and user-friendliness, not its clinical effectiveness against specific pain relief metrics.

Therefore, the requested information elements cannot be fully extracted from the provided document.

However, I can extract the information related to the performance data and usability in a structured way:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific acceptance criteria or reported performance for clinical efficacy (e.g., pain reduction levels). Instead, it lists various tests performed and implies that the measured values meet general "criteria" for performance characteristics. The table below focuses on the tests mentioned and their objectives.

Regarding the specific questions that cannot be answered from the provided text:

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

   • For the usability study: 30 users of various age, gender, and educational backgrounds.
   • For other tests (shelf life, biocompatibility, electrical, physical durability, RoHS, performance test): Sample sizes are not specified.
   • Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical effectiveness study with a "ground truth" (e.g., expert-assessed pain levels, clinical outcomes) is described. The tests are technical compliance and user experience.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical effectiveness study requiring adjudication is described.

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/imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical efficacy. For technical tests, the "ground truth" is defined by the technical specifications and standards (e.g., IEC standards, ISO standards).

8. The sample size for the training set: Not applicable, as no machine learning or similar model requiring a training set is described.

9. How the ground truth for the training set was established: Not applicable.

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