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Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.

Niti-S Colonic Comfort Stent 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 strictures.

The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of an implantable metallic stent and an introducer system.

The stent is made of nitinol wire and is designed as a flexible, fine mesh tubular prosthesis with several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm, while the Niti-S Colonic Comfort Stent is available in diameters of 22 mm and 24 mm. Both stent types are available in lengths of 60 mm, 80 mm, 100 mm, and 120 mm.

The stent delivery system accommodates a 0.035 in (0.89 mm) guidewire. It is advanced over the guidewire and passed through an endoscope into the duodenum or colon. Fluoroscopy is recommended to ensure accurate device placement.

This document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for medical devices. It primarily focuses on the substantial equivalence determination for the Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent.

Crucially, this document does not describe studies involving AI or software-based medical devices with performance metrics like sensitivity, specificity, or AUC. It is for a physical medical device (stent and delivery system) and the performance testing mentioned are mechanical and material integrity tests.

Therefore, I cannot provide the information requested regarding acceptance criteria and studies proving the device meets those criteria in the context of an AI/software device. The questions about sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are all irrelevant to the content of this document.

The "Performance Testing" section (page 7) lists the following non-clinical tests:

• Packaging strength and dye penetration
• Sterility verification
• Deployment accuracy test
• Deployment force test
• Dimensional test
• Tensile strength test (SDS)
• Trackability and visualization test
• Repositioning force test

These are standard engineering and material science tests for physical medical devices to ensure they function as intended and are safe. The document states that the results "demonstrate that the Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent are as safe and effective as the predicate device and supports a determination of substantial equivalence."

In summary, the provided document does not contain the information requested about AI device performance studies.

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The Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.

The Niti-S Colonic Comfort Stent is indicative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of the implantable metallic stent and introducer system.

The stent is made of nitinol wire. It is a flexible, fine mesh tubular prosthesis that has several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm while the Niti-S Colonic Comfort Stent has diameters of 22 and 24 mm. They both have lengths of 60, 80, 100, and 120 mm.

The introducer system accepts a 0.035 in (0.89 mm) guidewire. The introducer system is passed over the guidewire and through an endoscope into the duodenum or colon. Use of fluoroscopy is recommended to ensure correct placement of the device.

This document is a 510(k) summary for the Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent. It primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and performance data from bench testing. It does not describe a study involving human subjects or AI.

Here's an analysis of what is present and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

The document mentions that "The results of the bench testing show that the subject devices meet their specifications" for various tests. However, it does not provide a specific table outlining the acceptance criteria and the numerical results for each test. Instead, it lists the types of bench 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):

• Sample Size for Test Set: Not specified. The document only refers to "bench testing."
• Data Provenance: Not specified. Bench testing is typically performed in a lab setting, so country of origin isn't directly relevant in the same way as clinical data. This is not a study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This document describes bench testing of a medical device (stent and introducer system), not an AI algorithm or a diagnostic tool requiring expert ground truth in a clinical context.

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

Not applicable. As this is bench testing, there is no expert adjudication of image interpretations or clinical diagnoses.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a 510(k) submission for a physical medical device (stent), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported here.

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

No. This is for a physical medical device, not an algorithm.

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

Not applicable. For bench testing, the "ground truth" would be the engineering specifications and performance standards that the device is designed to meet. The document states the tests "meet their specifications."

8. The sample size for the training set:

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

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

Not applicable. This is not an AI/ML device.

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Evolution® Duodenal Stent System- Uncovered: This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.

Evolution® Colonic Stent System- Uncovered: 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 stent diameter is increased at either end to help provide resistance to migration. The total length of the stent is indicated by radiopaque markers on the inner catheter. indicating the actual length of the stent at the nominal stent diameter.

Introduction System Description:

The stent is mounted on an inner catheter, which accepts a 0.035 inch wire guide and is constrained by an outer catheter. The handle allows for desheathing to deploy the stent and resheathing to recapture the stent during stent deployment.

The provided text is a 510(k) summary for the Evolution® Duodenal Stent System - Uncovered and Evolution® Colonic Stent System - Uncovered. It describes the device, its intended use, and compares it to predicate devices. The document highlights a material formulation change in the outer catheter and discusses performance testing conducted to support substantial equivalence.

However, the document does not provide the detailed information requested in the prompt regarding acceptance criteria, specific study results, sample sizes for test and training sets, expert qualifications, or ground truth establishment methods in the context of an AI-based device. This is because the device in question is a medical stent system, not an AI-powered diagnostic or assistive tool. Therefore, the requested information elements are not applicable to the content provided.

The document mainly focuses on demonstrating substantial equivalence to a predicate device through:

• Identical Indications for Use.
• Identical Technological Characteristics except for the outer catheter material.
• Biocompatibility testing for the new material.
• Performance testing related to the device's mechanical functions (deployment, recapture, tensile strength, dimensions).

Since this is not an AI device, I cannot fill out the requested fields.

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This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.

Stent Description: 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.
Introducer System Description: 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.

I cannot fulfill this request. The provided text, including the "510(k) Summary," describes a medical device (Evolution™ Duodenal Stent System) and its intended use, but it does not contain any information about acceptance criteria, device performance, a study to prove acceptance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The text focuses on:

• Device description
• Indications for use
• Comparison to predicate devices
• General statement about performance (bench and clinical) testing being carried out to determine equivalence and verify safety/effectiveness, listing types of bench tests.

It does not provide the detailed results or methodology of these tests in a way that would allow me to answer your specific questions about acceptance criteria and study particulars. The document concludes with the FDA's clearance letter, stating the device is substantially equivalent to predicate devices.

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

The proposed WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System consists of two components: an implantable metal stent and a delivery system. The proposed stent is manufactured of Nitinol and has a 22mm body diameter with a 27mm distal flare diameter, and is offered in three lengths, 6cm, 9cm, and 12cm. 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.

The provided text is a 510(k) summary for the WallFlex™ Enteral Duodenal Stent System with Anchor Lock Delivery System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria.

The document states:

• "Clinical data in support of the proposed indication for the WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System has been included in this premarket notification."
• "Boston Scientific Corporation has demonstrated that proposed WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System is substantially equivalent to the currently marketed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System and in terms of the proposed indication to Boston Scientific's Wallstent Enteral Endoprosthesis."

This indicates that the clinical data presented was likely used to demonstrate substantial equivalence to existing predicate devices, rather than a standalone study designed to meet specific quantitative acceptance criteria for a novel device performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer many of the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided 510(k) summary.

Here's what can be inferred or stated based on the available text:

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

   • Not provided. The document focuses on substantial equivalence rather than a new device meeting pre-defined acceptance criteria.

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

   • Not provided. The document only states "Clinical data... has been included," without details on sample size or provenance.

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 provided. This information is generally not part of a 510(k) summary focused on substantial equivalence for a medical device like a stent.

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

   • Not provided.

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 medical implant (stent), not an AI-powered diagnostic tool engaging human "readers."

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

   • Not applicable. This is a medical implant, not an algorithm.

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

   • Not explicitly stated for the "clinical data" mentioned. For a medical device like a stent, ground truth would likely refer to clinical outcomes (e.g., successful stent placement, patency, complication rates, patient survival, symptom relief) verified through clinical follow-up, imaging, and potentially pathology if biopsies were taken. The document, however, does not detail how this "clinical data" was acquired or what specific endpoints it measured.

8. The sample size for the training set:

   • Not applicable/Not provided. This device is hardware; there is no "training set" in the context of an AI algorithm. Clinical trials involve patient cohorts, but the size of any such cohort is not disclosed.

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

   • Not applicable/Not provided.

Summary of what's present in the document:

• The device is a WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System.
• Its intended use is for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.
• The submission is a 510(k) premarket notification claiming "substantial equivalence" to predicate devices (WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System and Wallstent Enteral Endoprosthesis).
• Clinical data was included to support the proposed indication, but no details of the study (design, sample size, outcome measures) are provided in this summary.
• The FDA's letter confirms the determination of substantial equivalence.

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The Schneider (USA) Inc Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant neoplasms.

The WALLSTENT® Enteral Endoprosthesis is comprised of two components: the temporary (short-term) implantable metallic stent and the delivery device. The stent is composed of implant-grade cobalt-base superalloy wire braided in a tubular mesh configuration. The design configuration results in a stent that is flexible, compliant and The stent is available in multiple sizes. Physician preference and self-expanding. individual patient condition and/or anatomy will determine the appropriate size chosen.

This 510(k) submission for the WALLSTENT® Enteral Endoprosthesis does not contain a study that demonstrates the device meets acceptance criteria in the manner typically seen with AI/ML devices or new medical technologies requiring extensive clinical trials for performance validation. Instead, it relies on substantial equivalence to a predicate device and existing clinical literature.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not applicable in the context of a prospective clinical trial on the new device. The performance validation relies on tests performed on the predicate device and a review of clinical literature.
• Data Provenance: The device's performance is supported by:
  • Mechanical tests performed on the predicate device.
  • A "search of clinical literature" suggesting successful clinical in vivo experience of metal stents in the duodenal area (retrospective, likely international but not specified).

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. Ground truth, in this context, refers to the established safety and efficacy of the predicate device and general clinical experience with similar devices, not a new clinical evaluation for this specific device.
• Qualifications of Experts: N/A for establishing a specific ground truth for a test set of the device itself. The regulatory body (FDA) and the applicant's internal assessments rely on medical and scientific expertise.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The submission does not describe a test set requiring adjudication in the sense of expert consensus on diagnostic or outcome data for the new device. The FDA's review process itself involves expert evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This submission pre-dates widespread AI/ML applications in medical devices and does not involve human readers interpreting data assisted by an AI. The device is a physical stent.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study: No. This is a physical medical device (stent), not an algorithm or software-only device.

7. Type of Ground Truth Used

The "ground truth" for this submission is multi-faceted, relying on:

• Predicate Device Performance Data: Mechanical test results (fatigue, corrosion, radial force, deformation) on the legally marketed predicate device.
• Clinical Outcomes Data (from literature): Successful clinical in vivo experience with similar metal stents in decompressing strictures and relieving gastric outlet obstruction, as reported in published clinical literature.
• Engineering Equivalence: The assessment that the new device has identical materials, construction, and processing as the predicate.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This is not a machine learning device and therefore does not have a "training set" in that context. The "training" for the device's design and manufacturing comes from the predicate device and established engineering principles.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Established: Not applicable. As above, there is no "training set" in the AI/ML sense. The "ground truth" of what constitutes a safe and effective stent for the intended use is established through:
  • Years of clinical experience with similar devices.
  • Regulatory standards for materials and mechanical performance.
  • The proven performance and safety profile of the predicate device.

Summary Explanation:

This 510(k) submission leverages the concept of substantial equivalence. The applicant argues that the WALLSTENT® Enteral Endoprosthesis is equivalent to an already legally marketed device (the WALLSTENT® devices and specifically an existing Enteral Endoprosthesis) because:

1. It is made of identical materials and has identical construction and processing.
2. It introduces no new materials, design, or manufacturing processes.
3. Performance testing conducted on the predicate device demonstrated mechanical strength (fatigue, corrosion, radial force, deformation) within expected ranges, which is considered applicable to this new device due to their identical nature.
4. A review of clinical literature supports the successful use of metal stents in the duodenal area for the intended palliative treatment of strictures.

Therefore, the "proof" that the device meets acceptance criteria is not a new clinical study directly assessing the performance of this specific device against predefined clinical endpoints. Instead, it's an assertion of sameness to a device already deemed safe and effective, supported by indirect evidence from the predicate and general clinical experience. The FDA's acceptance (indicated by the 510(k) clearance letter) confirms their agreement with this claim of substantial equivalence.

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