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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 Segmented Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic, or extrinsic malignant turnors only, and occlusion of concurrent esophageal fistula.

The stent is provided pre-loaded in the delivery system. The stent is made up of several segments. The main frame is woven by Nitinol wire, and the connecting part is PTFE connecting loop. The stent with this segmented structure can flexibly conform to the curvature of the human body lumen, thereby reducing the stimulation of the end to the lumen. Silicone membrane applied to the stent covers the complete body of the stent along both flanges, which means the segmented esophageal stent is a fully covered stent. The stent is formed with a flange at either end. The increased diameter of the stent at the stent ends helps provide resistance to migration. The covering is intended to reduce the risk of tissue ingrowth and provides a occlusion for esophageal fistulas. To aid in visibility under fluoroscopy there are 4 bands at either end of the stent and 2 bands at the middle of the stent. The stent has a retrieval loop which can be used to reposition the stent during the initial placement procedure if desired. The delivery system allows for desheathing to deploy the stent and recapturing the stent during stent deployment. The device is supplied sterile, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.

The provided document is a 510(k) Summary for the Segmented Esophageal Stent System (K182910), which is a medical device. This document describes the device's technical characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device, not its performance against specific acceptance criteria in a clinical study for an AI/CADe device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study proving the device meets acceptance criteria cannot be extracted from this document, as it pertains to a different type of medical device submission (510(k) for a physical stent, not an AI/CADe device).

The document focuses on demonstrating that the new stent device is substantially equivalent to a previously cleared predicate device (CHOOSTENT™ Covered Esophageal Stent, K072094) based on material, design, manufacturing, and general performance testing (bench tests and biocompatibility).

Although I cannot provide the requested information in the format of an AI/CADe device study, here's a summary of the performance data included in this 510(k) submission, which is primarily focused on demonstrating safety and efficacy for a physical implantable device:

Performance Data Summary (for the physical stent device):

The Segmented Esophageal Stent System underwent various performance tests to demonstrate its substantial equivalence to the predicate device.

Biocompatibility Testing:

• Stent Biocompatibility Testing:
  • Vitro Cytotoxicity
  • Skin Sensitization
  • Irritation
  • Acute Systemic Toxicity
  • Pyrogen
  • Salmonella Reverse Mutation Test
  • In Vitro Mammalian Cell Gene Mutation Test
  • Muscle Implant
• Delivery System Biocompatibility Testing:
  • Vitro Cytotoxicity
  • Skin Sensitization
  • Irritation
  • Acute Systemic Toxicity

Device-Specific Performance Testing (Bench Tests):

• Visual Inspection
• Dimension Testing
• Deployment Force Testing
• Expansion Force Testing
• Compression Force Testing
• Corrosion Testing
• Tensile Strength Testing
• Sterility Testing
• Shelf Life Testing
• MR Compatibility Testing

Compliance Standards:

• ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process"
• ISO 11135 "Sterilization of Health Care Products-Ethylene Oxide-Part 1: Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices"
• FDA's biocompatibility guidance, Use of International Standard ISO-10993-7, "Biological Evaluation of Medical Devices-7: Ethylene Oxide Sterilization Residuals"
• Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses issued April 28th, 1998 (specifically "VIII Performance testing-Bench")

Conclusion of Testing:
The testing performed demonstrated that the proposed device and predicate device are equivalent in terms of performance characteristics relevant to their intended use (maintaining esophageal luminal patency).

Clinical Study:
No clinical study was included in this submission.

Regarding your specific points (and why they cannot be answered from this document):

1. Table of acceptance criteria and reported device performance: Not applicable for this type of submission. The document relies on equivalence to a predicate device, not predefined performance metrics for an AI/CADe system.
2. Sample size for test set and data provenance: No test set of medical images/data to assess AI performance. The "test sets" would refer to physical prototypes for bench testing.
3. Number of experts for ground truth and qualifications: Not applicable. Ground truth as typically understood for AI/CADe devices (e.g., expert consensus on image findings) is not relevant here.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This assesses human reader improvement with AI, which is irrelevant for a physical stent.
6. Standalone performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable, as there's no AI model being trained.
9. How ground truth for training set was established: Not applicable.

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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 is intended for the endoscopic placement of the selfexpanding nitinol stent for maintaining luminal patency in esophageal strictures. The flexible Agile Stent and through-the scope Delivery System allow for stent placement through direct visualization. The Agile™ Esophageal Stent System is supplied sterile.

The Agile™ Stent is a flexible. MR conditional, self-expanding, braided nitinol stent. The proximal and distal ends of the stent have a flare which is larger in diameter than the stent body. The stent wires at each end of the flare are looped. A suture is threaded within the looped ends of both the proximal and distal stent flares to aid in repositioning during initial placement. The proposed Agile Stent is both fully and partially covered in a silicone covering.

The Agile™ Stent comes preloaded and constrained in the delivery system. The delivery system consists of two coaxial shafts compatible with a minimum 3.7mm working channel of a therapeutic gastroscope. The exterior tube is used to constrain the stent before deployment and to reconstrain the stent after partial deployment. The delivery system has radiopaque and visual markers to aid the user in accurate stent placement. There are three visual markers on the delivery system handle to aid in the placement of the stent under endoscopic visualization and four radiopaque markers on the interior of the delivery system to aid in placement of the stent under fluoroscopic visualization.

The provided document describes the Agile Esophageal Stent System, a medical device intended for maintaining esophageal luminal patency in esophageal strictures. The information does not detail diagnostic or AI/ML-based performance. Instead, it focuses on the engineering and biocompatibility validation of the stent system itself. Therefore, many of the requested fields related to AI/ML model performance, such as MRMC studies, ground truth establishment for training/test sets, and sample sizes for training sets, are not applicable.

Here's an analysis based on the available information:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The acceptance criteria for the Agile Esophageal Stent System are implicitly defined by the successful completion of a series of biocompatibility and bench tests, along with demonstrating substantial equivalence to predicate devices. The study proving the device meets these criteria involved performing these tests and comparing the results to pre-defined specifications or to predicate device performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for each bench test or biocompatibility test. It reports "Pass" for each test, indicating that the tested samples met the pre-defined criteria. The tests are bench tests performed on the device components or complete systems, and biocompatibility tests conducted in vitro and in vivo (e.g., animal models). The provenance of this data is from the manufacturer's (Boston Scientific Corporation) internal testing. These are prospective tests conducted on the newly designed device.

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

Not Applicable. This request is relevant for AI/ML validation where expert consensus establishes ground truth for diagnostic accuracy. Given this is a physical medical device (stent), the "ground truth" is established by engineering specifications, material science standards, and biocompatibility guidelines, rather than expert interpretation of medical images or data.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among human readers or experts in diagnostic studies to establish a consensus ground truth. This is not relevant for the bench and biocompatibility testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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-based diagnostic tool that assists human readers.

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

Not Applicable. This is a physical medical device (stent), not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on:

• Engineering specifications and standards: For mechanical properties, dimensions, deployment accuracy, etc.
• Biocompatibility standards (e.g., ISO 10993): For material safety tests.
• Comparison to predicate devices: For comparative bench testing, the performance of the predicate devices serves as a benchmark for what is considered acceptable.

8. The sample size for the training set

Not Applicable. This document describes 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 there is no AI/ML model, there is no training set or associated ground truth.

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

The Esophageal Stent System consists of a self-expanding metal stent and a stent introduction system. The stent is provided pre-loaded in the introduction system. The handle allows for desheathing to deploy the stent and resheathing recapturing the stent during stent deployment. The stent is woven from nitinol wire. The stent is formed with a flange at either end. The increased diameter of the stent ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part or fully of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for esophageal fistulas. To aid in visibility under fluoroscopy there are four bands at either end of the stent. The stent has a lasso loop which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.

The provided text is a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd. Esophageal Stent System (K172813). It details the device, its intended use, comparison to a predicate device, and performance data. However, this document does not describe the acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an AI/algorithm-based medical device.

The questions posed in the request (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth establishment) are relevant to the evaluation of AI/ML-based medical devices, which typically involve performance metrics like sensitivity, specificity, AUC, etc., derived from studies comparing algorithm output to established ground truth.

This 510(k) submission is for a physical medical device (an esophageal stent) and its material and mechanical properties. The "Performance Data" section in the document refers to:

• Biocompatibility Testing: Evaluating the biological safety of the materials used in the stent.
• Device-specific performance tests: Visual inspection, dimension testing, deployment force, expansion force, compression force, corrosion testing, tensile strength, sterility, shelf life, and MR compatibility.

There is no mention of an AI/ML algorithm, or any study design that would involve a "test set," "training set," "ground truth" derived from expert consensus, or "human readers improving with AI assistance."

Therefore, I cannot answer the specific questions about acceptance criteria for an AI device or a study proving its performance from the provided text. The document explicitly states: "No clinical study is included in this submission." This further indicates that the type of performance evaluation relevant to AI/ML devices (which often involves clinical data and observer studies) was not part of this 510(k) submission.

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This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.

The Evolution® Esophageal Stent System - Partially Covered consists of a self-expanding metal stent and a stent introduction system. The stent is provided pre-loaded in the introduction system. The handle allows for desheathing to deploy the stent and resheathing recapturing the stent during stent deployment. The stent is woven from nitinol wire. The stent is formed with a flange at either end. The increased diameter of the stent at the stent ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for tracheoesophageal fistulas. To aid in visibility under fluoroscopy there are four bands at either end of the stent. The stent has a lasso loop which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only.

This document describes the Cook Ireland Ltd. Evolution® Esophageal Stent System - Partially Covered and its substantial equivalence to predicate devices, but does not contain any information about acceptance criteria, device performance metrics, or study results related to an AI/Machine Learning device or software.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided text pertains to a traditional medical device (an esophageal stent) and focuses on its physical characteristics, materials, and non-clinical performance testing (biocompatibility, simulated use, corrosion, etc.) to demonstrate substantial equivalence for regulatory clearance. It does not involve any AI/ML components or studies that would involve performance metrics like sensitivity, specificity, or reader studies with AI assistance.

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This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.

Stent Description: This flexible, self-expanding stent is constructed of nitinol wire with a silicone cover. 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. There is a lasso at the proximal end of the stent whose purpose is to reposition the stent as needed.

Introducer System Description: The stent is mounted on an inner catheter, which accepts a 0.035 inch guidewire and is constrained by an outer catheter. A pistol-grip delivery handle allows stent deployment or rccapture.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a table of acceptance criteria or quantitative device performance metrics that would typically be found in a study. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to already marketed devices.

Instead of performance metrics against acceptance criteria, the document states:

• "Non clinical testing was carried out to determine the equivalence of the Evolution™ Esophageal Stent System to the predicate devices and to verify the safety and effectiveness of the device."
• "The following is a summary of the testing carried out: deployment force testing, expansion force testing, compression force testing, dimensional testing, corrosion testing and tensile strength testing."

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

The document describes non-clinical testing on the device itself (stent and introducer system components) rather than testing on patients or human subjects. Therefore, the concept of a "test set" in the context of patient data (e.g., medical images for an AI device) or data provenance (country of origin, retrospective/prospective) is not applicable here. The testing involved various engineering and materials science tests on the device.

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

This section is not applicable as the testing described is non-clinical (device characteristic testing) and does not involve expert interpretation or establishment of ground truth in a clinical sense.

4. Adjudication method for the test set

This section is not applicable as the testing involved non-clinical, objective measurements of device characteristics, not clinical assessments requiring 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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance. This document describes the clearance of a physical medical device (an esophageal stent), not an AI/software device.

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

This section is not applicable as the device is a physical medical implant (an esophageal stent), not an algorithm or AI system.

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

For the non-clinical tests conducted, the "ground truth" would be the physical properties and performance characteristics of the device measured against predetermined specifications or industry standards for similar devices. This is not clinical ground truth in the sense of expert consensus or pathology.

8. The sample size for the training set

This section is not applicable. The device is a physical stent and does not involve a training set for an algorithm.

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

This section is not applicable. The device is a physical stent and does not involve a training set for an algorithm.

Summary of what the document does tell us:

The document describes the Cook Ireland Ltd. Evolution™ Esophageal Stent System. It is a flexible, self-expanding nitinol stent with a silicone cover, designed to maintain patency of malignant esophageal strictures and/or seal tracheoesophageal fistulas.

The basis for its 510(k) clearance (K080359) by the FDA in 2008 was its substantial equivalence to several legally marketed predicate devices:

• Esophageal Z Stent with Dua Anti-Reflux Valve (K011591)
• Wallstent II Esophageal Prosthesis (K940395)
• Ultraflex™ Esophageal NG Stent System (K032930)

To demonstrate this equivalence and verify safety and effectiveness, Cook Ireland Ltd. performed non-clinical testing, including:

• Deployment force testing
• Expansion force testing
• Compression force testing
• Dimensional testing
• Corrosion testing
• Tensile strength testing

The specific numerical results of these tests and the acceptance criteria they had to meet are not detailed in this summary document, but the FDA's clearance indicates that these tests were sufficient to demonstrate substantial equivalence.

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The Alveolus ALIMAXX-E™ Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors and for occlusion of esophageal fistulae.

The Alveolus ALIMAXX-E™ Esophageal Stent System is comprised of two components: the completely covered, self-expanding Nitinol stent and the delivery system. The ALIMAXX-E™ Esophageal Stent System is available in several diameters and lengths. The single-patient-use components of the ALIMAXX-E™ Esophageal Stent System are provided non-sterile.

The provided document is a 510(k) summary for a medical device (ALIMAXX-E™ Esophageal Stent System) seeking substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating that a modified device is as safe and effective as a previously cleared device, primarily through performance testing and comparison of technological characteristics. It does not include a clinical study with acceptance criteria and reported device performance in the way a de novo or PMA submission might.

Therefore, I cannot directly extract the table of acceptance criteria and reported device performance that would typically come from a clinical trial demonstrating efficacy against specific endpoints. Similarly, information such as sample sizes for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and training set details are not present in this 510(k) summary because it is not a study of a new AI/software device or a clinical trial of a novel therapy.

Instead, the document focuses on demonstrating substantial equivalence through:

• Comparison of technological characteristics: Materials, biocompatibility, performance properties, sterilization, and packaging are compared to the predicate device.
• Physical test results: These were performed to show that the modified device performs similarly to the predicate.
• Biocompatibility test results: These were conducted according to FDA guidance.

Here's a breakdown of what can be inferred or directly stated from the document, and what is explicitly missing due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (Inferred): For a 510(k) submission seeking substantial equivalence for a physical device modification, the "acceptance criteria" are not reported as specific clinical endpoints. Instead, they are implicitly related to demonstrating that the modified device's performance (mechanical, material, biological) is as good as or equivalent to the predicate device. This means the modified device must:
  • Maintain lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
  • Occlude esophageal fistulae.
  • Exhibit comparable physical properties (e.g., radial force, flexibility, fatigue resistance, deployment characteristics) to the predicate.
  • Have equivalent or acceptable biocompatibility.
• Reported Device Performance: The document states: "Physical test results were performed and biocompatibility test results included tests recommended in FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" (issued on April 28, 1998)." The specific quantitative results of these tests are not provided in this summary. The conclusion is that these tests support substantial equivalence.

Study Information (As per the provided 510(k) summary):

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to physical and biocompatibility testing in a lab setting, not a clinical "test set" in the context of an AI/diagnostic study. The provenance of material or device samples for physical testing is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of expert consensus, is not relevant for this type of submission which focuses on device engineering and biological performance testing.

4. Adjudication method for the test set: Not applicable. No human expert adjudication of clinical outcomes 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 a physical medical device, not an AI or diagnostic imaging device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical and biocompatibility testing, the "ground truth" would be the established engineering specifications for the predicate device, and the relevant ISO/ASTM standards for material properties and biological safety.

8. The sample size for the training set: Not applicable. There is no AI algorithm or machine learning model described that would require a training set.

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

In summary, the provided 510(k) pertains to a physical medical device modification seeking substantial equivalence and therefore does not contain the detailed clinical study information relevant to software/AI devices or new clinical indications that your questions imply. The "study" here consists of engineering tests and biocompatibility assessments to confirm the modified device's equivalence to a cleared predicate.

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The proposed device is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula

The proposed WallFlex™ Partially Covered Esophageal Stent System consists of a selfexpanding metal stent and a delivery system. The proposed stent is manufactured of Nitinol and offered with a partial silicone covering. The stent configurations include two diameters, a 18mm body diameter with a 23mm flare, and a 23mm body diameter with a 28mm flare and three lengths. The 18mm body diameter stent is offered in 103mm, 123mm, and 153mm stent lengths. The 23mm body diameter stent is offered in 105mm, 125mm, and 155mm stent lengths. The proposed delivery system consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released.

The provided text describes a 510(k) premarket notification for the "WallFlex™ Partially Covered Esophageal Stent System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria, and thus the structure of the prompt is not fully applicable.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or quantitative performance metrics are provided in the document. The submission states that "Comparative performance testing was performed to establish substantial equivalence between the proposed WallFlex™ Partially Covered Esophageal Stent System, and the predicate devices." This testing included, but was not limited to:

• Dimensional evaluation
• Radial expansion force
• Radial compression force
• Deployment and reconstrainment force
• Bond integrity

Since this is a 510(k) submission, the "acceptance criteria" for these tests would typically be that the device performs equivalently to the predicate devices or within established design specifications. However, the exact thresholds or comparative results are not detailed in this summary.

Note: The document only states that comparative testing was performed, but does not provide the specific results or numerical acceptance thresholds for these tests.

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

The document does not specify the sample size used for the comparative performance testing. It also does not mention data provenance in terms of country of origin or whether the data was retrospective or prospective, as the testing described appears to be bench testing or in-vitro performance evaluation rather than clinical data.

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

Not applicable. The performance data discussed relates to physical device characteristics and engineering tests, not clinical evaluations requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (esophageal stent) and focuses on engineering and performance characteristics compared to predicate devices, not on the interpretation of medical images by human readers.

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

Not applicable. This device is a physical stent and delivery system, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing would be the established engineering specifications and the performance characteristics of the predicate devices. For example, for "dimensional evaluation," the ground truth would be the design specifications and the dimensions of the predicate devices. For "force" tests, the ground truth would be the expected force ranges or the force measurements of the predicate devices. This type of "ground truth" is not established by experts in the clinical sense, but by engineering design and testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and no "training set" in that context is mentioned or implied.

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

Not applicable, as there is no training set for an AI/ML algorithm mentioned.

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