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The WallFlex Colonic Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectomy in patients with malignant strictures.

The WallFlex Duodenal Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.

The WallFlex Colonic Soft Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectomy in patients with malignant strictures.

The WallFlex Duodenal Soft System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.

The WallFlex Colonic Stent System with Anchor Lock Delivery System and WallFlex Duodenal Stent System with Anchor Lock Delivery System each consist of two components: the implantable metal stent and the anchor lock delivery system.

The proposed stent is manufactured of Ntinol. The stent will be offered in two diameters, 22mm with a 30mm flare. Each diameter will be available in three lengths, 6cm, 9cm, and 12cm. The WallFlex Duodenal Stent will only be offered in the 22mm/27mm stent diameter (all lengths) preloaded on the 230cm Anchor Lock Delivery System. The WallFlex Colonic Stent will be offered in the 22mm/27mm and 25mm/30mm diameters (all lengths) preloaded on the 230cm or 135cm Anchor Lock Delivery System. The Anchor Lock delivery system consist of a coaxial tubing assembly that constrains the stent on the until the stent is released by retracting the exterior tube.

The WallFlex™ Colonic Soft Stem with Anchor Lock Delivery System and WallFlex™ Duodenal Soft Stent System with Anchor Lock Delivery System each consist of two components: the implantable metal stent and the Anchor Lock Delivery System.

The stent is manufactured from Nitinol wires braided together to form a cylinder with a flared end. The wires are looped at both stent ends and welded at the non-flared end. The WallFlex Colonic Soft Stent and the WallFlex Duodenal Soft Stent will be offered in three diameters: 22 mm with a 27 mm flare, 20 mm flare, and 18 mm with a 23 mm flare. Each diameter will be available in three lengths, 6cm, 9cm, and 12cm. The stent sizes that are shared between the WallFlex Colonic Soft Stent and the WallFlex Duodenal Soft Stent are identical in all aspects of their design; the only difference is in indication.

The stent is compressed on a flexible catheter for delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during deployment. There are 3 radiopaque marker bands on the diftate placement; the exterior tube marker band, the deployment limit marker band, and the post deployment marker band. The exterior tube marker band is located adjacent to the leading end the deployment limit marker band is located adjacent to the trailing end of the stent. The deployment limit marker band identifies the stent beyond which the stent cannot be reconstrained. The post deployment marker band, situated 4cm from the trailing end of the constrained stent, helps to facilitate accurate placement of the stent. The only design difference between product offerings is how the stent is loaded onto the delivery system. The colonic stent is loaded with the flare is distal to the operator, and the duodenal stent is loaded with the flare is proximal to the operator.

The Anchor Lock stent holder is located at the trailing end of the stent on the delivery system to aid in reconstrainment when repositioning the stent. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in. / 0.89 mm guidewire. The device may be inserted through the working channel of a 9 French endoscope (minimum channel diameter 3.2mm scope). The WallFlex Colonic/Duodenal Soft Stent with Anchor Lock Delivery System will be offered in 230cm.

The provided text pertains to a 510(k) premarket notification for a medical device, specifically the WallFlex Colonic and Duodenal Stent Systems. This document is a regulatory clearance letter from the FDA, asserting that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document does not describe the acceptance criteria and study proving a device meets those criteria for an AI/ML-enabled medical device. The product under review (WallFlex Stent Systems) is a physical, implantable medical device, not an AI/ML diagnostic or therapeutic system. Therefore, the concepts of "acceptance criteria for an AI/ML device," "test set sample size," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth type," "training set size," and "ground truth establishment for training" are not applicable to the content of this FDA clearance letter.

The letter focuses on demonstrating substantial equivalence to already cleared predicate devices based on:

• Intended Use/Indications for Use: The current devices have identical indications for use as their predicates, which are for palliative treatment of malignant colonic and duodenal strictures and large bowel obstructions.
• Technological Characteristics: The devices are stated to be identical to the predicates in terms of principles of operation, technical characteristics, performance, and materials (Nitinol stents with anchor lock delivery systems).
• Non-Clinical Tests: The documentation mentions compliance with FDA guidance for MR safety (ASTM F2503e2020), which is a standard non-clinical test for implantable devices, not an AI/ML algorithm validation.

In summary, this document is a 510(k) clearance for a conventional medical device and does not contain the information requested about acceptance criteria and study data for an AI/ML-enabled medical device.

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The WallFlex Colonic Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectomy in patients with malignant strictures.

The WallFlex Duodenal Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.

The WallFlex Colonic Stent System with Anchor Lock Delivery System and WallFlex Duodenal Stent System with Anchor Lock Delivery System each consist of two components: the implantable metal stent and the anchor lock delivery system.

The proposed stent is manufactured of Nitinol. The stent will be offered in two diameters, 22mm with a 27mm flare and 25mm with a 30mm flare. Each diameter will be available in three lengths, 6cm, 9cm, and 12cm. The WallFlex Duodenal Stent will only be offered in the 22mm/27mm stent diameter (all lengths) preloaded on the 230cm Anchor Lock Delivery System. The WallFlex Colonic Stent will be offered in the 22mm/27mm and 25mm/30mm diameters (all lengths) preloaded on the 230cm or 135cm Anchor Lock Delivery System. The Anchor Lock delivery system consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube.

There is no information regarding the acceptance criteria of an AI/ML device in the provided text. The document pertains to the 510(k) clearance of the WallFlex Colonic Stent System and WallFlex Duodenal Stent System, which are physical medical devices, not AI/ML software. Therefore, I cannot address aspects like sample size for test sets, data provenance, expert consensus, MRMC studies, or training set details as these are not relevant to the described device and its clearance process.

The document focuses on the substantial equivalence of the proposed WallFlex stent systems to their predicate devices, with the only change being to the surface finish of the nitinol wire. Performance data provided is for bench testing of the physical stent system, not for an AI/ML algorithm.

Here's what can be extracted from the provided text regarding device performance:

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

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 for these bench tests.
• The data provenance is not mentioned, but it is implied to be laboratory testing of the physical device components.

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. Ground truth for these engineering performance tests would be based on predefined specifications and measurement standards, not expert medical opinion.

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

• Not applicable. The tests are bench tests with objective outcomes (pass/fail against engineering specifications). Reconciliation or adjudication methods are not typically used for this type of 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 device is a physical stent system, not an AI-assisted diagnostic tool.

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 (expert consensus, pathology, outcomes data, etc):

• The "ground truth" for these tests would be internal engineering specifications and relevant industry standards for stent performance, which are not detailed in this summary but are demonstrably met for the device to "Pass."

8. The sample size for the training set:

• Not applicable. There is no training set for a physical device.

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

• Not applicable. There is no training set for a physical device.

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The WallFlex Colonic Soft Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectory in patients with malignant strictures.

The WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.

The WallFlex™ Colonic Soft Stent System with Anchor Lock Delivery System and WallFlex™ Duodenal Soft Stent System with Anchor Lock Delivery System each consist of two components: the implantable metal stent and the Anchor Lock Delivery System.

The stent is manufactured from Nitinol wires braided together to form a cylinder with a flared end. The wires are looped at both stent ends and welded at the non-flared end. The WallFlex Colonic Soft Stent and the WallFlex Duodenal Soft Stent will be offered in three diameters: 22 mm with a 27 mm flare, 20 mm with a 25 mm flare, and 18 mm with a 23 mm flare. Each diameter will be available in three lengths, 6cm, 9cm, and 12cm. The stent sizes that are shared between the WallFlex Colonic Soft Stent and the WallFlex Duodenal Soft Stent are identical in all aspects of their design; the only difference is in indication.

The stent is compressed on a flexible catheter for delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during deployment. There are 3 radiopaque marker bands on the delivery system to facilitate placement; the exterior tube marker band, the deployment limit marker band, and the post deployment marker band. The exterior tube marker band is located adjacent to the leading end of the stent and the deployment limit marker band is located adjacent to the trailing end of the stent. The deployment limit marker band identifies the stent deployment limit, the point beyond which the stent cannot be reconstrained. The post deployment marker band, situated 4cm from the trailing end of the constrained stent, helps to facilitate accurate placement of the stent. The only design difference between the colonic and duodenal product offerings is how the stent is loaded onto the delivery system. The colonic stent is loaded with the flare is distal to the operator, and the duodenal stent is loaded with the flare is proximal to the operator.

The Anchor Lock stent holder is located at the trailing end of the stent and secures the stent on the delivery system to aid in reconstrainment when repositioning the stent. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in. / 0.89 mm guidewire. The device may be inserted through the working channel of a 9 French endoscope (minimum channel diameter 3.2mm scope). The WallFlex Colonic/Duodenal Soft Stent with Anchor Lock Delivery System will be offered in 230cm.

The provided text is a 510(k) premarket notification for a medical device. It does not describe or include a study that proves the device meets specific acceptance criteria in the manner of an AI/ML medical device.

The document describes the submission of a new stent system (WallFlex Colonic Soft Stent System with Anchor Lock Delivery System and WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System) and claims substantial equivalence to existing predicate devices (WallFlex Enteral Colonic/Duodenal Stent with Anchor Lock Delivery System).

The "Performance Data" section lists various bench tests conducted to establish this substantial equivalence. These are engineering-focused tests for physical properties and functionality, not clinical studies involving human or even observational data on device performance in patients or with human readers.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it pertains to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC study, standalone performance, ground truth establishment for training set).

The document explicitly states:

• "Performance testing (bench) was successfully completed to establish substantial equivalence between the proposed device and the predicate device." This confirms the tests were bench tests, not clinical studies.
• The tests listed are for physical characteristics: Trackability/Pushability, Marker Band Visualization, Deployment Force, Reinstrainment Force, Stent Reinstrainment Percentage, Withdrawal of Partially Deployed Stent, Deployment Accuracy, Bond Integrity, Unconstrained Stent Length, Unconstrained Stent Diameter, Flare Diameter, Stent Hoop Force (Expansion and Compression), Stent Fatigue Resistance, Stent Flexibility, Stent Corrosion Resistance, Endoscope Compatibility Device Outer Diameter, Potentiodynamic, Foreshortening, Comparative Hoop Force (Expansion and Compression).

In summary, there is no information in the provided text that aligns with the request for AI/ML device performance study details.

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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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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 patients with malignant 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 is 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, and expanded in the body by pulling the outer sheath of the delivery system. The HANAROSTENT® LowAx™ Colon/Rectum (NNN) and HANAROSTENT® LowAxTM Duodenum/Pylorus (NNN) are intended for single use only.

The provided text describes a 510(k) premarket notification for two devices: HANAROSTENT LowAx™ Colon/Rectum (NNN) and HANAROSTENT LowAx™ Duodenum/Pylorus (NNN). This notification aims to demonstrate substantial equivalence to previously cleared predicate devices.

However, the document does not contain information about acceptance criteria for device performance based on a clinical study or a study proving that the device meets such criteria. Instead, it focuses on demonstrating technological equivalence and presents the results of bench testing to confirm safety and effectiveness.

Therefore, I cannot provide a table of acceptance criteria and reported device performance derived from a clinical study, nor can I answer questions about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these pertain to clinical or AI performance studies which are not detailed in this document.

The document does provide information pertinent to physical and material performance, as outlined in the "Performance Summary" section.

Here's what can be extracted from the document regarding the performance validation performed:

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

The document describes bench testing performed to confirm safety and effectiveness compared to predicate devices, but it does not explicitly list quantitative acceptance criteria or specific reported performance values for these tests. It only lists the types of tests conducted.

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

Not applicable. The document describes bench testing, not a clinical study with human subjects.

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 document describes bench testing, not a clinical study requiring expert ground truth for interpretation.

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

Not applicable. The document describes bench testing, not a clinical study requiring adjudication of expert interpretations.

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 document describes a medical device (stent) and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. The document describes a medical device (stent) and does not involve an algorithm with standalone performance.

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

For the bench testing, the "ground truth" would be the expected physical or mechanical properties and behaviors of the stent as per engineering specifications and relevant standards. This is inherent in the design control system and the performance tests themselves.

8. The sample size for the training set:

Not applicable. The document describes a medical device (stent) and its physical and mechanical performance testing, not a machine learning model requiring a training set.

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

Not applicable. The document describes a medical device (stent) and its physical and mechanical performance testing, not a machine learning model requiring a training set.

Summary of available information related to performance (bench testing):

The document states that "Appropriate bench testing was performed to confirm the safety and effectiveness of the proposed devices as compared to the identified predicate device." This testing was conducted "as per the design control system" and consulted "Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th, 1998."

Types of Bench Tests Conducted:

• Axial force
• Compression force
• Corrosion
• Deployment force
• Deployment accuracy
• Dimensions
• Expansion force
• Repositioning force
• Stent separation
• Tensile strength
• Trackability

Biocompatibility Assessment:

• Assessed in accordance with ISO 10993-1:2003, 2012.

Conclusion from Bench Testing:
The non-clinical data (bench testing) supports the safety of the proposed devices and demonstrates that they are safe and effective and will perform as intended in the specified use conditions. It also concludes that the proposed device is substantially equivalent to the predicate devices based on these tests and technological characteristics.

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This device is used for palliative treatment of colonic obstruction or colonic strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

This flexible, self-expanding stent is constructed of nitinol wire. The total length of the stent is indicated by radiopaque markers on the inner catheter, indicating the actual length of the stent at nominal stent diameter. The stent has flanges at both stent ends. The stent is provided with a body diameter of 25mm and flange diameters of 30mm and is provided in three lengths 6cm, 8cm and 10cm. The stent is mounted on an inner catheter, which accepts a 0.035 inch wire guide and is constrained by an outer catheter. A pistol-grip delivery handle allows stent deployment or recapture. The introducer system diameter is 10 Fr and working length is 230cm.

The provided text describes the Cook Ireland Evolution® Colonic Stent System and its performance testing. However, it does not explicitly define acceptance criteria in a quantifiable manner, nor does it present the study results in a way that directly maps to specific performance metrics with clear pass/fail thresholds. The information provided is more descriptive of the types of tests conducted and the general outcomes.

Therefore, I will extract relevant information that implies acceptance criteria and describe the study in the best way possible given the available text.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The document states that the bench testing was "successfully completed" and provided "reasonable assurance" and that clinical data demonstrated "acceptable" levels of success. This suggests that certain pre-defined thresholds were met, but the specific numerical acceptance criteria (e.g., a specific percentage for technical success or a specific force measurement range) are not explicitly stated in this summary.

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

• Sample Size for Test Set: 80 patients
• Data Provenance: The study was a "registry study," implying real-world data collection, but no specific country of origin is mentioned beyond "Cook Ireland Ltd" being the manufacturer. It's prospective in the sense that data was collected during the use of the device in these patients with follow-up, suggesting it's not purely retrospective.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set:

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:

This information is not applicable as the device is a physical medical stent, not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a physical medical stent, not an AI algorithm.

7. The Type of Ground Truth Used:

For the clinical study, the "ground truth" was established by clinical observation and assessment of patient outcomes. This included:

• Technical success of the stent placement.
• Clinical success in achieving palliation or relief of obstruction.
• Acute procedural success.
• Symptom relief.
• Reporting and assessment of adverse events (perforation, migration, obstruction, and their association with device malfunction or complication).

8. The Sample Size for the Training Set:

This concept is not applicable to this type of device and study. The "training set" is generally used for machine learning models, which is not what is being described here. The clinical study involved 80 patients who received the device, and their outcomes informed its effectiveness.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no "training set" in the context of an AI/algorithm. For the clinical study, the "ground truth" (i.e., the actual clinical outcomes and adverse events) was established through direct patient follow-up and medical assessment.

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The Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

The proposed Wallflex Enteral Stent with Anchor Lock Delivery System consists of 2 components: an implantable metal stent and a delivery system. The proposed stent is manufactured of Nitinol and offered in two diameters, a 25mm body with a 30mm flare, and a 22mm body with a 27mm flare. Each diameter is offered in three lengths, 6cm, 9cm, and 12cm. The proposed Anchor Lock delivery system consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube.

The provided text describes a 510(k) summary for the Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System. It states that this is a request for an expanded indication for a device that already has existing market clearance and introduces "no new materials or design changes."

Therefore, the performance data presented in the original K042065 submission was not repeated for this K061877 submission. This means that the current document does not contain the acceptance criteria or the study that proves the device meets those criteria for the expanded indication. Instead, it relies on the predicate device's prior approval.

As such, I cannot fill in the requested table and information based solely on the provided text. The document explicitly states:

"As this is a request for an expanded indication and introduces no new materials or design changes the performance testing presented in K042065 was not repeated."

To answer the prompt fully, one would need to refer to the original K042065 submission, which is not provided here.

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The Ultraflex™ Precision™ Colonic Stent is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

The proposed Ultraflex™ Precision™ Colonic Stent System consists of a self-expanding metal stent and a delivery catheter. The proposed stent consists of Nitinol wires wound together to form a cylinder with a flared distal section. The proposed stent is mounted on a delivery catheter. The stent is compressed onto the tapered delivery catheter shaft and bound with braided nylon suture using a crochet stitch. The stent is deployed by holding the handle stationary and pulling a ring to unravel the crochet stitch.

This document describes a 510(k) submission for the Ultraflex™ Precision™ Colonic Stent System. It is an application for an expanded indication for a device that is already on the market. Therefore, the information provided focuses on the substantial equivalence to predicate devices and clinical data for the new indication, rather than detailed performance studies for the device itself.

Here's an analysis based on the provided text, addressing the requested information points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a tabular format. The submission relies on demonstrating substantial equivalence to existing predicate devices for its technological characteristics and presenting clinical data to support the new indication.

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

• Test Set Sample Size: Not specified in the provided text. The document mentions "Clinical data in support of the proposed indication has been collected and is presented within this submission." However, the exact number of patients or cases is not detailed here.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

• This information is not provided in the given text.

4. Adjudication Method for the Test Set

• This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study is not mentioned or implied. The submission focuses on device performance and clinical effectiveness for a palliative indication, not on the improvement of human reader performance with AI assistance.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (stent system), not an AI algorithm. The performance data refers to the device's functional characteristics and clinical outcomes.

7. Type of Ground Truth Used

• Given the context of a colonic stent for malignant strictures, the "ground truth" for the clinical data would likely be based on clinical observation, patient outcomes, medical diagnoses (e.g., confirmed malignant neoplasms), and potentially imaging or endoscopic confirmation of stricture palliation. The text itself does not explicitly define the "type of ground truth," but these are standard for such medical devices.

8. Sample Size for the Training Set

• This information is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.

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

• This information is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.

Summary based on the document:

The submission for the Ultraflex™ Precision™ Colonic Stent System asserts substantial equivalence based on:

• Technological Characteristics: The proposed device has identical materials, construction, and manufacturing processes as the currently marketed Ultraflex Precision Colonic Stent (K030769).
• Performance Data: For the new indication, "Clinical data in support of the proposed indication has been collected and is presented within this submission." The document explicitly states that performance testing from the prior K030769 submission was not repeated because there are no new materials or design changes.

The focus is on demonstrating that the new indication is safe and effective and that the device is substantially equivalent to legally marketed predicate devices (K030769 and K000281). Detailed breakdowns of clinical study methodology (sample sizes, expert qualifications, adjudication, specific metrics) are not provided in this summary document.

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The WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.

The proposed WallFlex™ Enteral Stent with Anchor Lock Delivery System consists of two components: an implantable metal stent and a delivery system. The proposed stent is two components: an insplantaoffered in two diameters: 25mm body with a 30mm flare, mandracetal or over with a 27mm flare. Each diameter is offered in three lengths, 6cm, 9cm, and 12cm. The proposed Anchor Lock delivery consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube.

Here's an analysis of the provided text regarding the acceptance criteria and study for the WallFlex™ Enteral Colonic Stent:

It's important to note that the provided document is a 510(k) summary for a premarket notification, not a full clinical study report. Therefore, it focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. The "performance data" mentioned here refers to engineering and bench testing, not clinical studies in humans.

Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical acceptance criteria (e.g., "radial force must be > X Newtons") or detailed numerical results for the WallFlex™ stent. Instead, it states that the performance for these categories was compared and found to be substantially equivalent to predicate devices.

Study Details

1. Sample size used for the test set and the data provenance:
   This document describes bench testing (mechanical, physical, and material compatibility tests), not a clinical test set involving human patients. Therefore, terms like "sample size for the test set" (in a clinical sense) and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable here. The tests were likely conducted in a laboratory setting, and the "samples" would be individual stents/delivery systems.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This is not applicable. Ground truth, in the clinical sense, refers to confirmed diagnoses or outcomes. The "ground truth" for the engineering performance tests would be the established engineering standards or the performance of the predicate devices, against which the new device's performance was compared. This would be evaluated by engineers or scientists performing the tests.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This is not applicable as it pertains to clinical data interpretation or consensus. Bench testing results are typically quantifiable and do not require expert adjudication in the same manner.

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:
   This is not applicable. MRMC studies are for evaluating diagnostic tools, often involving AI, and human reader performance. This document concerns a medical device (a stent) and its mechanical/physical equivalence, not an AI-powered diagnostic.

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

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For the engineering performance tests, the "ground truth" was the established performance characteristics of the predicate devices and/or relevant engineering standards. The goal was to demonstrate that the WallFlex™ stent performed similarly or met the same benchmarks as the already approved predicate devices.

7. The sample size for the training set:
   This is not applicable. There is no "training set" in the context of this device's engineering performance testing. This concept applies to machine learning algorithms.

8. How the ground truth for the training set was established:
   This is not applicable for the same reason as above.

Summary of what the document does provide:

• Type of Study: Comparative performance testing (bench testing) and comparison to predicate devices, not clinical trials.
• Purpose: To establish substantial equivalence of the WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System to two named predicate devices (Ultraflex™ Precision™ Colonic Stent System, K030769 and Wallstent Enteral Endoprosthesis with Unistep Plus Delivery System, K000281) for 510(k) clearance.
• Evaluated Characteristics: Dimensional evaluation, fatigue testing, radial force comparison, deployment and reconstrainment force, bond integrity, and MRI compatibility.
• Conclusion: The device was found to be substantially equivalent based on these comparative tests.

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