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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 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 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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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 use of this device is restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.

The Colonic Plus Regular, Small and Straight shape Hydrokits is a plastic, non-sterile, single use product colonic irrigation system that is used as an accessory with lower bowel Colonic irrigation systems intended to instill water into the colon through a nozzle inserted 2" 3" into the rectum to evacuate the contents of the lower colon.

The provided text is a 510(k) premarket notification for a medical device called "Colonic Plus Regular, Small, and Straight Shape Hydrokits." Based on the content, it's a submission for a colonic irrigation system accessory, asserting substantial equivalence to a predicate device.

Crucially, this document focuses on demonstrating physical and functional equivalence of a medical device (a hydrokit for colonic irrigation) to a legally marketed predicate device, as required for a 510(k) submission to the FDA. It is not a clinical study report for an AI/ML-based medical device addressing a specific disease or condition.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study proving device performance for an AI/ML device. The provided text discusses:

• Device Description: A plastic, non-sterile, single-use product colonic irrigation system accessory.
• Comparison to Predicate Device: Detailed comparison of design, materials, and intended use to the Transcom Hydrokit (K131852).
• Non-Clinical Data: Water pressure leakage, tensile & compression tests, and biocompatibility testing (cytotoxicity, irritation, sensitization). These are engineering and material safety tests, not performance metrics related to diagnostic accuracy or clinical outcomes.
• Clinical Data: Explicitly states, "No clinical studies are submitted to support this premarket notification."

Since the device in question is a physical medical device and not an AI/ML algorithm, and no clinical studies were submitted, the requested information (performance metrics, test set details, expert involvement, MRMC studies, standalone algorithm performance, training set details) related to AI/ML device validation does not apply to this document.

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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 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 Colonic Splinting Overtube is indicated for use with an endoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the endoscope during the colonoscopy procedure. The Colonic Splinting Overtube is intended to provide for easy advancement of the scope while minimizing mucosal pinching.

The US Endoscopy Colonic Splinting Overtube is an overtube that includes a soft distal . tip, an irrigation line, proximal seal at the handle, a hydrophilic coating, and an optional adhesive anchor.

The provided text describes a 510(k) premarket notification for a medical device, the US Endoscopy Colonic Splinting Overtube. It does not contain the information requested in the prompt regarding acceptance criteria, device performance metrics, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication method), or MRMC comparative effectiveness studies.

The document is a regulatory submission demonstrating substantial equivalence to predicate devices, focusing on design characteristics, indications for use, and a statement that "performance testing consisted of functional bench testing." It does not provide specific data, metrics, or detailed study results that would allow for the completion of the requested table and study description.

Therefore, most of the requested information cannot be extracted from the provided text.

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

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

No specific acceptance criteria or quantitative performance metrics are provided in the document. The document states: "Performance testing consisted of functional bench testing." and "All components that come into direct contact with the patient have a long history of use in medical devices and are biocompatible." It concludes that the device is "safe and effective for its intended use" based on these general statements and comparison to predicate devices.

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

Not mentioned in the document.

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 mentioned in the document.

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

Not mentioned in the document.

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 an overtube, an accessory for endoscopy, not an AI diagnostic tool. No MRMC study was mentioned.

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

Not applicable. This is a medical device (overtube), not a standalone algorithm.

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

Not mentioned in the document. The "performance testing" was described as "functional bench testing," implying laboratory or engineering tests, not clinical evaluations against a medical ground truth.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

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

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The Libbe Colonic Nozzle is to be used as the Device/Nozzle inserted into the rectum when used with the LIBBE Lower Bowel Evacuation System. The Device/Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examination.

The LIBBE Colonic Nozzle device is a plastic, non-sterile, single use product for use as an accessory with lower bowel evacuation systems or enema kits. The Device/Nozzle is intended to be inserted two to three inches into the rectum for instilling water into the colon region. The LIBBE Colonic Nozzle is designed as a one-piece, injection molded, medical grade plastic accessory. The nozzle has an open tip with a slight bulb shape that has two small holes in its wall. The proximal end of the nozzle has a barbed fitting for attachment to plastic tubing from the colonic irrigation, or enema, system.

This document describes a 510(k) submission for the LIBBE Colonic Nozzle, a device that is substantially equivalent to a previously cleared device. Therefore, a comprehensive study proving the device meets acceptance criteria as would be expected for a novel device is not presented. The information provided focuses on demonstrating substantial equivalence rather than independent performance testing against predefined acceptance criteria.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly define acceptance criteria in terms of specific performance metrics for the LIBBE Colonic Nozzle. Instead, it argues for substantial equivalence to a predicate device, the Libbe Rectal Tube (K962259).

The performance "reported" is primarily a comparison of the new device's characteristics to the predicate device, implying that equivalence in these characteristics constitutes meeting the necessary "performance."

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

No separate test set with a defined sample size for performance evaluation is mentioned. The submission relies on a comparison to a predicate device and biocompatibility testing. The data provenance for the biocompatibility testing (ISO 10993) is not specified in terms of country of origin or whether it was retrospective/prospective outside of the standard testing protocol.

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)

No experts were used to establish ground truth for a test set in the context of device performance, as no such test set is described. The “ground truth” related to safety and effectiveness is largely based on the predicate device's prior clearance and the existing regulatory framework for colonic irrigation systems.

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

Not applicable. There was no test set requiring expert adjudication for performance evaluation.

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 medical device (a nozzle), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance or AI assistance is irrelevant.

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

Not applicable. This device is not an algorithm.

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

The document relies on the "ground truth" established by the prior clearance of the predicate device (Libbe Rectal Tube K962259) and generally accepted standards for medical device safety and performance, specifically:

• Substantial Equivalence: The primary ground truth is that the predicate device is safe and effective when used as intended.
• Biocompatibility Standards: The device meets ISO 10993, which serves as a recognized standard for evaluating biological effects of medical devices.

8. The sample size for the training set

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

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

Not applicable. There is no training set for this type of device.

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