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The HANAROSTENT® Esophagus Upper (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 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 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 Upper (CCC) is intended for single use only.

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The Niti-S Esophageal Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

The Esophageal TTS Stents and Niti-S Esophageal Stents consist of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency. A length of suture is attached to one end of the stent and can be used for stent repositioning during initial placement, in accordance with the instructions for use.

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The Resilience Fully Covered Esophageal Stent System is intended for maintaining esophageal luminal patency in patients with esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and for occlusion of esophageal fistulae.

The MERIT ENDOTEK® Resilience™ Fully Covered Esophageal Stent System is a through-the-scope system comprised of two components: the radiopaque self-expanding nitinol stent and the delivery system. The stent is completely covered with a biocompatible silicone membrane. Stent expansion results from the physical properties of the metal and the proprietary geometry. The stent is designed with unique geometrical features at the distal and proximal ends to anchor the stent and resist migration. The proximal and distal ends of the stent are threaded with suture intended for use in repositioning and removal of the stent.

The stents come in nine (9) sizes, comprising all combinations of three lengths (5cm, 6cm, and 7cm) and three midbody diameters (14mm, 17mm, and 20mm). The midbody lengths are 1cm, 2cm, and 3cm with the flared ends comprising the remaining length. The ends of the stents are larger in diameter than the midbody.

There is one 10.5Fr delivery system used to deploy all 9 stents.

The provided FDA 510(k) clearance letter and summary for the Resilience Fully Covered Esophageal Stent System describes non-clinical testing to demonstrate substantial equivalence to a predicate device. However, it does not include information about clinical studies involving human readers or AI algorithms. The clearance is based on the device itself (the stent system), not an AI algorithm performing diagnosis or analysis.

Therefore, many of the requested points, especially those pertaining to AI performance, human reader studies, and ground truth establishment for AI, cannot be answered from the provided text.

Here's an analysis based on the information provided, focusing on the device's non-clinical testing:

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The study described is a series of non-clinical, in-vitro tests on the mechanical and material properties of the Resilience Fully Covered Esophageal Stent System and its delivery system.

Information Not Found in the Provided Text:

Since this is a clearance for a medical device (esophageal stent) and not an AI/software device, the following points related to AI studies are not applicable or not present in the provided document.

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

   • This device clearance is based on non-clinical, in-vitro testing. It does not utilize "test sets" in the context of clinical data for AI analysis. The "test sets" here refer to batches of manufactured stents and delivery systems for mechanical and material property evaluation. Specific sample sizes for each non-clinical test are not detailed in this summary, but the summary states "all of the above testing passed the predetermined specifications" and "All design validation requirements were met."

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 as this is not an AI/software clearance based on expert-labeled clinical data. Ground truth for non-clinical device testing is typically based on engineering specifications and direct physical measurements/observations.

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

   • Not applicable.

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-assisted device.

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

   • Not applicable.

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

   • For the non-clinical testing, the "ground truth" or "reference standard" would be the pre-defined engineering specifications and performance criteria derived from established medical device standards and the predicate device's performance benchmarks. For biocompatibility, the ground truth is compliance with ISO 10993-1.

8. The sample size for the training set:

   • Not applicable, as this is not an AI/software device. There is no "training set" in the context of machine learning.

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

   • Not applicable.

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

The WallFlex Esophageal Partially Covered and Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

The Ultraflex Esophageal NG Stent System allows placement of a self-expanding metallic stent within the esophagus. The systems consist of a flexible delivery system preloaded with an expandable with or without a cover. The WallFlex Esophageal Stent System consists of a self-expanding esophageal metal stent and a delivery system.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for Boston Scientific's Ultraflex Esophageal NG Stent System and WallFlex Esophageal Stent System. This document explicitly states that the proposed devices are identical to their legally marketed predicate devices in design, material, chemical composition, fundamental technology, principle of operation, sterilization, packaging, shelf-life, and manufacturing process.

Therefore, the submission does not describe a study involving acceptance criteria and device performance based on a test set, expert ground truth, or AI assistance. The clearance is based on the substantial equivalence of the new devices to existing, already cleared devices.

Here's why the requested information cannot be extracted from this document:

• No new performance data is presented. The core argument for clearance is "identity" to predicates, not "improved performance" or meeting specific performance thresholds through new testing against a defined ground truth.
• The document states, "The testing performed on the proposed Ultraflex Esophageal Stent System and WallFlex Esophageal Stent System demonstrates the devices are substantially equivalent." This testing would likely be engineering or bench performance tests (e.g., stent radial force, deployment accuracy, material compatibility) to demonstrate the identity and safety of the new devices, not clinical performance against a diagnostic task or a clinical outcome. These tests are not detailed in the provided summary.
• The context is a 510(k) premarket notification for a Class II device. For such devices, especially those claiming identity to predicates with established performance, a comparative effectiveness study involving human readers with and without AI assistance is generally not required or performed.
• AI/Machine Learning is not mentioned. The document describes physical medical devices (stents), not AI-powered diagnostic or therapeutic tools.

In summary, the provided text does not contain the information requested regarding acceptance criteria, study design (test set, ground truth, experts, adjudication, MRMC, standalone), or training set details because the basis for clearance is substantial equivalence (identity) to existing devices, not a new performance claim for an AI/ML-driven device or a device requiring new clinical performance validation in the way described in your prompt.

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The Agile Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

The Agile Esophageal Stent System consists of a self-expanding esophageal metal stent and a delivery system. The Agile Esophageal Stent is available partially or fully covered with silicone covering and in three diameter sizes: 14mm, 18mm and 23mm. The 14mm and 18mm diameter stents are pre-loaded on a 10.5Fr delivery system and the 23mm diameter stent is pre-loaded on an 18.5Fr delivery system. The 10.5Fr delivery system has a single central lumen to accommodate a 0.035" (0.89 mm) guidewire. The 18.5Fr delivery system has a single central lumen to accommodate a 0.038" (0.97mm) guidewire.

The provided text, K233837, is an FDA 510(k) clearance letter for the Boston Scientific Agile Esophageal Stent System. This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

Instead, this document is a Traditional 510(k) submission for a non-software medical device (an esophageal stent system). The text explicitly states that the proposed device is "identical to the predicate Agile Esophageal Stent System (K180144 and K211960) in intended use, indications for use, classification, principles of operation, technical characteristics, performance, and materials." This means the submission is based on substantial equivalence to a previously cleared device, not on new performance studies with specific acceptance criteria that would typically be seen for an AI/ML device.

Therefore, I cannot provide the requested information as it is not present in the given document. The document confirms:

• Device Name: Agile Esophageal Stent System
• Regulation Number: 21 CFR 878.3610 (Esophageal Prosthesis)
• Regulatory Class: Class II
• Product Code: ESW
• Predicate Devices: K180144 and K211960 (Agile Esophageal Stent System and Agile Esophageal OTW Stent System, respectively)
• Basis for Clearance: Substantial equivalence to previously cleared predicate devices, an "identical" comparison in design, material, chemical composition, fundamental technology, principle of operation, sterilization, packaging, shelf-life, and manufacturing process.

The document discusses "Non-Clinical and/or Clinical Tests Summary & Conclusions," but it does so in the context of confirming the substantial equivalence to the predicate, implying that the tests performed (if any beyond confirming identical characteristics) were to demonstrate this equivalence, not to meet new, specific performance acceptance criteria for a novel AI/ML algorithm.

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The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

The Esophageal TTS Stents that are the subject of this 510(k) are identical to the devices cleared in K221482, with the exception of the modification to its introducer system. The Esophageal TTS Stents consist of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency.

This document is a 510(k) premarket notification for a medical device called the "Esophageal TTS Stent." It explains that the new device is substantially equivalent to a previously cleared device (K221482) manufactured by the same company, Taewoong Medical.

The core of the document focuses on demonstrating this substantial equivalence, noting that the stent itself is identical to the predicate device, with modifications only to the introducer system (the delivery mechanism). Therefore, much of the testing performed is related to the performance and biocompatibility of this modified introducer system.

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

This document is a marketing submission for a medical device (Esophageal Stent) that does not involve AI or software. Therefore, many of the requested criteria related to AI/software performance validation, such as "acceptance criteria for an AI model," "MRMC study," "standalone algorithm performance," "ground truth establishment for training set," are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the standard non-clinical performance and biocompatibility testing for a physical medical device, not an AI or software component.

Here's a detailed response to the applicable sections of your request:

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

The document does not provide a formal table with specific numerical acceptance criteria and reported numerical performance for each test. Instead, it lists the types of performance tests conducted and then states a general conclusion that the device "meets its design requirements and performs as intended" and is "as safe and effective as the predicate device."

However, we can infer the types of tests and the general outcome:

Notes on Acceptance Criteria:

• For biocompatibility tests, the acceptance criteria would be defined by the ISO standards, e.g., "non-cytotoxic," "not a sensitizer," etc.
• For performance tests (Deployment, Deployment Force, Dimensional, Tensile Strength), the acceptance criteria would be specific to the device's engineering specifications, such as "deployment within X seconds," "deployment force less than Y Newtons," "dimensions within Z tolerance," "tensile strength greater than W," etc. These specific numerical criteria and results are not provided in this summary document. The document only states that the testing was conducted and found to demonstrate substantial equivalence.

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

• Sample Size:
  • The document does not specify the sample sizes used for the non-clinical performance tests (Deployment, Deployment Force, Dimensional, Tensile Strength).
  • For biocompatibility, the sample sizes would be typical for the specific ISO test methods (e.g., a certain number of mice for acute systemic toxicity, guinea pigs for sensitization), but these are not explicitly detailed.
• Data Provenance:
  • This is a submission for a medical device (stent and introducer), not data related to a clinical study or AI model.
  • The testing pertains to the physical characteristics and interaction of the device components.
  • The manufacturer is Taewoong Medical Co., Ltd., based in the Republic of Korea. It's highly probable the testing was conducted there or at subcontracted labs.
  • The tests are prospective in nature, as they are performed on newly manufactured devices or materials to demonstrate compliance for premarket submission.

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. This device is a physical medical device (stent and introducer system) and does not involve a diagnostic AI or imaging interpretation. Therefore, there is no "ground truth" derived from expert interpretation of images or clinical data in the context of an AI model.
• The "ground truth" for this device's performance is established by engineering specifications, physical measurements, and standardized biological safety tests. The "experts" involved would be engineers, material scientists, and toxicologists/biologists conducting and interpreting the non-clinical tests.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth in machine learning contexts (e.g., for radiology readings) where there might be disagreement among human readers. Since this is a submission for a physical device based on non-clinical performance and biocompatibility testing, such adjudication methods are not relevant.

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 is for a physical medical device (esophageal stent) and its introducer system. It does not involve AI or software, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.

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

• Not Applicable. This device does not have an "algorithm" component. It is a physical medical device.

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

• The "ground truth" for this device is based on engineering specifications and established test methodologies.
  • For performance tests (Deployment, Deployment Force, Dimensional, Tensile Strength), the ground truth is defined by the pre-defined design requirements and specifications (e.g., a stent must deploy within a certain time, or a certain force is required for deployment).
  • For biocompatibility tests, the ground truth is defined by the results of standardized in vitro and in vivo biological tests as per ISO 10993 series, indicating the material's safety for contact with the body.
• It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI-related devices.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device. Therefore, there is no "training set." The device's design is based on engineering principles and knowledge gained from previous device iterations (the predicate device).

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

• Not Applicable. As there is no training set (being a physical medical device, not an AI), there is no ground truth establishment for a training set.

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The HILZO Esophageal Stents are indicated for use in esophageal strictures caused by intrinsic malignant tumors.

The HILZO Esophageal Stents are partially covered and fully covered, self-expanding tubular prosthesis designed to maintain patency of esophageal strictures. The HILZO Esophageal stents are available loaded on two styles of delivery devices, Over the Wire (OTW) and Through the Scope (TTS). The OTW delivery devices are 14Fr and the TTS is 10.5Fr to enable delivery through the working channel of an endoscope. The stents are made of Nitinol wire and are designed to prevent stent migration due to peristaltic motion and tumor in-growth. The stents are available in a variety models, diameters and lengths.

The document provided is a 510(k) Premarket Notification from the FDA for a medical device: the Hilzo Esophageal Stents. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, not for establishing novel safety and effectiveness through clinical trials or performance studies involving complex metrics like those for AI/ML devices (e.g., sensitivity, specificity, clinical workflow improvement).

Therefore, the vast majority of the requested information regarding acceptance criteria, study design, ground truth establishment, expert adjudication, MRMC studies, and training set details are not applicable to this particular document. This document focuses on demonstrating that the new device is as safe and effective as a previously cleared device, primarily through bench testing comparing physical and mechanical properties, and biocompatibility.

Here's what can be extracted and what cannot:

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

The document provides a comparative table where "acceptance criteria" are implicitly defined by similarity to the predicate device's performance, often with an explicit acceptance range (e.g., "fell within the +/- 5% difference acceptance criteria").

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

The document mentions "extensive biocompatibility data" and various "Non-Clinical Performance Testing" types (shelf-life, expansion force, compression force, etc.). However, it does not specify sample sizes for these tests. The data provenance would be that of the manufacturer's internal testing. It's retrospective in the sense that the tests were completed before the submission. No country of origin for specific test data is provided, but the manufacturer is Thoracent, Inc. in Huntington, NY, USA.

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

This is not applicable. For this type of device (a physical medical implant), "ground truth" is established through engineering and biological performance standards, not expert medical opinion on a data set. The device is evaluated on its physical and mechanical properties and biocompatibility.

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

Not applicable. There is no expert adjudication process for bench testing results in the way there would be for image interpretation in an AI/ML study.

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 (stent), not an AI/ML diagnostic or assistive software. MRMC studies are used for evaluating the impact of AI on human reader performance for diagnostic tasks.

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 this device, "ground truth" is established through:

• Engineering specifications and standards: For mechanical properties like expansion and compression force, dimensions, tensile strength, kink resistance.
• Biocompatibility standards (e.S. ISO 10993): For biological safety, ensuring the materials are not toxic or harmful to the body.
• Sterilization validation: Ensuring the device can be terminally sterilized.
• MR safety standards: To determine if the device is safe for patients undergoing MRI.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. As above, no training set for an AI/ML model exists for this device.

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The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

The Esophageal TTS Stents consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency.

The provided document is a 510(k) premarket notification for the Taewoong Medical Co., Ltd. Esophageal TTS Stent. It states that the device is "substantially equivalent" to previously cleared predicate devices (K211706, K123205, K113551) with the "exception of a modification to the Indications for Use statement."

As such, this document does not contain acceptance criteria for this specific submission with new performance data to prove the device meets these criteria. Instead, it relies on the previous clearances and argues that the change in indication does not affect safety and efficacy, therefore no additional performance data is required for this 510(k).

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from this document. The document explicitly states:

• No additional biocompatibility information is required.
• Not applicable for Electrical safety and electromagnetic compatibility (EMC) as it contains no electrical components.
• Not applicable for Software Verification and Validation Testing as it contains no software.
• No additional performance data is required for Bench Testing because no design modifications were made.
• Not applicable for Animal Testing.
• Not applicable for Clinical Data.

The 510(k) submission relies on the substantial equivalence principle, asserting that since the new device is identical in design and materials to previously cleared devices, and the change in indication does not introduce new risks, the prior performance data of the predicate devices is sufficient.

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The Agile Esophageal Partially Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

The Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

The Agile Esophageal 23mm Partially Covered and Fully Covered Over the Wire (OTW) Stent System is comprised of a metallic implantable stent pre-loaded inside of a flexible delivery system. The stent is made from braided Nitinol wires which form a self-expanding. radiopaque (RO) cylindrical mesh. The stent has flares at each end to aid in minimizing migration after the stent is placed in the esophagus. The flares are a wider diameter than the stent body. The wire ends are looped at the end of the stent. The proximal and distal stent ends each have a continuous suture threaded around their circumferences. The suture is intended to aid in removal or repositioning during the initial stent placement procedure, to be used in the event of incorrect placement. The stent is available in either partially covered or fully covered configurations. The stent is covered with a silicone polymer to restrict turnor in-growth through the wire mesh and to occlude concurrent esophageal fistulas. The proposed stent is nearly identical in design to its predicate Agile Esophageal Stent System (K180144). The main difference between the proposed and the predicate stent is the type of delivery system used with the stent. The proposed Agile Esophageal OTW Stent is intended to be used with an over-the-wire delivery svstem. whereas the predicate Agile Esophageal Stent used a through-the-scope delivery system.

The over-the-wire delivery system is a co-axial tube design. The exterior tube is used to constrain the stent before deployment and to reconstrain the stent after partial deployment. The exterior tube has clear distal section so that the constrained stent is visible. A yellow transition zone on the inner tube of the delivery system is visible between the stent and the blue outer sheath. The system has RO and visual markers to aid in accurate stent placement.

The provided text describes a submission to the FDA for the Agile Esophageal OTW Stent System, establishing substantial equivalence to previously cleared predicate devices. The submission focuses on bench testing and biocompatibility to demonstrate this equivalence, rather than a clinical study evaluating the device's diagnostic performance with human readers and AI.

Therefore, many of the requested criteria related to clinical performance, expert ground truth, and AI assistance cannot be extracted from this document.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance attributes for the device, and the acceptance criteria are implicitly that the device "PASS" these tests, demonstrating substantial equivalence to the predicate devices.

Additionally, for biocompatibility:

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

The study conducted was a bench testing for mechanical performance and biocompatibility testing. The document does not specify a "test set" in the context of patient data or image data. Therefore, details like country of origin or retrospective/prospective nature are not applicable. The sample size for each specific bench test is not provided in this summary, only the outcome.

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

Not applicable. This device is a medical implant (stent) and its submission is based on engineering performance data and biocompatibility, not on diagnostic performance where human experts establish ground truth.

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

Not applicable, as no human expert adjudication on a test set (e.g., medical images) was performed.

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

No MRMC study was done, and the device is not an AI-assisted diagnostic tool.

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

Not applicable, as this is a physical medical device, not a software algorithm.

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

For the bench testing, the "ground truth" or reference for acceptance was the product specifications of both the proposed device and its nearly identical predicate devices. For biocompatibility, the ground truth was compliance with ISO 10993-1.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not a machine learning model. There is no training set in this context.

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® 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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