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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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The Niti-S Biliary Speed D Stent is indicated for the palliation of malignant strictures in the biliary tree.

The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent is a flexible and expandable tubular device made of Nitinol wire. Two Nitinol wires are woven in a hook-type design. The stent design is identical to the predicate device cleared in K073667. The Stent Delivery System is a disposable system for the delivery and deployment of the stent at the target position.

The provided text is an FDA 510(k) clearance letter and summary for a medical device called the "Niti-S Biliary Speed D Stent." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than performing a de novo clinical study to establish performance against acceptance criteria for a novel AI/software medical device.

Therefore, the information required to populate a table of acceptance criteria and a detailed study proving device performance (especially for an AI/software product, as implied by questions like sample size for training data, expert consensus, MRMC studies, etc.) is not present in this document.

Specifically, the document states:

• "Software Verification and Validation Testing: Not applicable. The subject device contains no software of any type." (Page 8)
• "Animal Testing: Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device." (Page 9)
• "Clinical Data: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." (Page 9)

The 510(k) pathway for this device relies primarily on:

• Identical Indications for Use
• Highly similar technological characteristics to a predicate device (Niti-S Biliary Stent, K073667).
• Non-clinical bench testing to confirm physical characteristics and performance (e.g., integrity, radial force, material properties) and biocompatibility testing for material changes in the delivery system.
• Sterilization and Shelf Life testing.

As such, I cannot provide the requested information about acceptance criteria and study details for an AI/software medical device based on this document. The document describes a physical medical device (stent and delivery system), not an AI or software product.

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The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.

Optimos™ Cystotome is an electrode which uses heat generated from the application of high frequency (HF) energy through the monopolar electrode to puncture a hole in tissue. Following a fine-needle aspiration (FNA) procedure, it is positioned over a guidewire, so the applied part is located at the area of interest. The Optimos™ Cystotome is for use to drain pancreatic pseudocysts. The Optimos™ Cystotome is a single use device provided sterile to the user. No reprocessing is performed by the user. The device is provided in three sizes, which have different diameters and tip lengths. The device itself consists of 3 parts: handle, sheath, and tip.

The device is the Optimos™ Cystotome. The study described focuses on bench testing to demonstrate substantial equivalence to a predicate device, the Wilson-Cook Cystotome.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Thermal Effects Comparison:
  • Optimos™ Cystotome (Subject Device): 18 samples (Model number OCT1906)
  • Cystotome™ Cystoenterostomy Needle Knife (Predicate Device): 18 samples (Model number CST-10)
• Data Provenance: This was a bench test conducted in a laboratory setting using porcine stomach and duodenum tissue. The document does not specify the country of origin of the data beyond the manufacturer (Taewoong Medical Co., Ltd. from Korea) performing the tests. It is retrospective in the sense that the data has already been collected and analyzed.

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

• The document does not specify the use of experts to establish ground truth for the bench testing. The ground truth for thermal damage was established by quantitative measurements of thermal damage zones under a microscope, analyzed using histological strain and NADH.

4. Adjudication method for the test set

• An explicit adjudication method (e.g., 2+1, 3+1) is not mentioned or implied. The measurements and evaluations appear to be made against objective criteria.

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

• No MRMC comparative effectiveness study was done. This device is an electrosurgical accessory, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

• N/A. This is a medical device (Cystotome), not an algorithm. The performance described is for the device itself (its ability to puncture tissue and the thermal effects it produces) in controlled bench testing.

7. The type of ground truth used

• For the thermal effects comparison, the ground truth was objective physical measurements derived from histological analysis of tissue samples (porcine stomach and duodenum). This involved measuring the length, width, and depth of the thermal damage zone under a microscope and analyzing it using histological strain and NADH.

8. The sample size for the training set

• N/A. This device does not involve machine learning or AI, so there is no concept of a training set.

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

• N/A. As there is no training set, this question is not applicable.

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

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

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

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

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

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

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

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The Niti-S Biliary Slim M Stent is indicated for the palliation of malignant strictures in the biliary tree.

The Niti-S Biliary Slim M Stent consists of the implantable metallic stent and introducer system. The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 7 radiopaque markers; 3 in each end 1 in the center. It has a diameter of 6 or 8 mm and the length ranges from 40 to 120mm.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Niti-S Biliary Slim M Stent." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials for novel devices. As such, the document does not describe acceptance criteria for an AI/algorithm-driven device or study details for such a device, but rather for a physical medical device (a stent).

Therefore, I cannot extract the information required by your prompt, which specifically asks for criteria and study details related to an AI/algorithm-driven device like:

1. Acceptance criteria and device performance table: The document describes the device, its intended use, and compares its technical characteristics to predicate devices. It does not provide performance metrics like sensitivity, specificity, or AUC which would be relevant for an AI/algorithm.
2. Sample size and data provenance: There is no mention of a test set, training set, or data provenance from patient images, as this is not an AI/algorithm.
3. Experts for ground truth and qualifications: Not applicable, as there's no ground truth establishment for an AI.
4. Adjudication method: Not applicable.
5. MRMC study and effect size: No AI assistance or human reader performance is discussed.
6. Standalone performance: No algorithm is being evaluated.
7. Type of ground truth: Not applicable.
8. Training set sample size: Not applicable.
9. Ground truth for training set: Not applicable.

Instead, the document focuses on:

• Bench Testing: Describing physical tests performed on the stent (e.g., Pitting Corrosion Potential, Dimensional Verification, Radial Compression Force) and the delivery system (e.g., Delivery, Deployment, Withdrawal).
• Biocompatibility Testing: Stating that the material is identical to a previously cleared predicate device.
• Electrical Safety and EMC/Software Verification and Validation: Stating "Not applicable" as the device contains no electrical components or software.
• Animal Testing / Clinical Data: Stating "Not applicable" as these were not deemed necessary to establish substantial equivalence for this device.

In summary, the provided text describes the regulatory clearance process for a physical medical device (a stent) under the 510(k) pathway, and therefore does not contain the information requested about acceptance criteria and studies for an AI/algorithm-driven device.

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

The Esophageal TTS Stent consists 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 10 radiopaque markers; 4 in each end and 2 in the center. It has a body diameter of 18, 20 and 22mm, and a total length from 60 to 150mm. The surface of the body portion of the stent is covered with silicone. The Esophageal TTS Stent is provided in two configurations, either fully covered with silicone or with both heads not covered in silicone (bare). The introducer system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The stent introducer system is passed over the guidewire and through an endoscope into the esophagus. The stent may be positioned appropriately using the X-ray markers for guidance under fluoroscopy.

The provided text is a 510(k) summary for the Esophageal TTS Stent. It describes the device, its intended use, and a comparison to predicate devices, along with performance data. However, it explicitly states that no clinical data or animal testing were performed to establish substantial equivalence.

Therefore, the study that proves the device meets acceptance criteria is not a clinical study involving human or animal subjects, but rather bench testing.

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

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

The document states: "All samples met their acceptance criteria, demonstrating that when manufactured to specification, the device functions as intended and can be found substantially equivalent to the predicate device." However, the specific acceptance criteria for each test (e.g., a specific force range for the Deployment Force Test) are not detailed within this document. Only the types of tests conducted are listed.

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

• Sample size: The document states that bench testing was conducted on "both the 22mm diameter size and the 220cm length" of the device. It does not provide a specific number of units tested for each test.
• Data provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer, Taewoong Medical Co., Ltd., which is based in Korea. This is a retrospective evaluation of the device performance during its development and prior to submission.

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

Not applicable. This device's substantial equivalence was established through bench testing, not a clinical study requiring expert assessment of patient data.

4. Adjudication method for the test set

Not applicable, as this was not a clinical study involving human judgment. The outcome of the bench tests would have been objective measurements against predetermined (but not specified in this document) specifications.

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 medical device (stent) and not an AI/software product, so an MRMC study and AI assistance are not relevant to its performance evaluation as described.

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

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

7. The type of ground truth used

The "ground truth" for the bench testing would be the engineering specifications and design requirements for the device. The tests validated that the manufactured device performed in accordance with these established technical criteria.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve machine learning or a "training set" in the context of AI.

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

Not applicable, as no training set was used.

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For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Esophageal TTS Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a flexible, expandable tubular device made of Nitinol wire and are either fully silicone covered or partially silicone covered (the body is covered but both heads remains uncovered). This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.

The provided text describes the regulatory clearance for the Esophageal TTS Stent but does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML or diagnostic performance metrics.

The document is a 510(k) summary for a medical device (an esophageal stent), which focuses on demonstrating substantial equivalence to a predicate device based on engineering and mechanical performance tests, rather than clinical efficacy studies with human subjects that would typically involve acceptance criteria for diagnostic accuracy, sensitivity, or specificity.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device evaluation (e.g., AI/ML-driven diagnostic tools).

Information Based on the Provided Text:

Here's what can be inferred or directly stated from the document, acknowledging that most of the requested fields are not applicable to this type of device clearance:

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

   Acceptance Criteria (Type of Test)	Reported Device Performance (Summary)
   Expansion Force Testing	Demonstrated safety and effectiveness.
   Compression Force Testing	Demonstrated safety and effectiveness.
   Dimensional Testing	Demonstrated safety and effectiveness.
   Deployment Testing	Demonstrated safety and effectiveness.
   Deployment Force Testing	Demonstrated safety and effectiveness.
   Tensile Strength Testing	Demonstrated safety and effectiveness.
   Packaging Adhesive Strength Testing	Demonstrated safety and effectiveness.
   MR Compatibility	Demonstrated safety and effectiveness.
   Overall Conclusion	"The performance testing showed that the Esophageal TTS Stent with a larger body diameter of 20mm is as safe, as effective, and performs as well as or better than the predicate device."

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

   • This information is not provided in the document. The performance data section refers to engineering tests on the device, not a human reader or image-based test set.

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)

   • This information is not provided and is not applicable to the type of device (a medical implant) and the type of testing described (engineering performance tests).

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

   • This information is not provided and is not applicable to the type of testing 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

   • No, an MRMC study was not done. This document describes the clearance of an esophageal stent, not an AI/ML diagnostic tool.

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

   • This is not applicable as the device is a physical medical implant, not an algorithm.

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

   • The "ground truth" for the engineering performance tests would be the established engineering specifications and physical properties benchmarks. This is not explicitly detailed in the document beyond stating that "Performance Data" was collected per FDA "Guidance for Industry - Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses."

8. The sample size for the training set

   • This is not applicable as the document describes the clearance of a physical medical device, not an AI/ML algorithm that requires a training set.

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

   • This is not applicable as the document describes the clearance of a physical medical device.

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For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Esophageal TTS Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a flexible, expandable tubular device made of Nitinol wire and covered with silicone. This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency.

This document describes the premarket notification (510(k)) for the Taewoong Medical Esophageal TTS Stent. However, it does not contain information about the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered medical device. The information provided is for a traditional medical device (esophageal stent).

Therefore, I cannot fulfill your request as it pertains to AI/ML device performance and testing. The document focuses on the substantial equivalence of the Esophageal TTS Stent to previously cleared predicate devices based on physical and mechanical properties, not on an algorithm's performance.

Here's why I cannot provide the requested information from the given text:

• No AI/ML Component: The device described, the Esophageal TTS Stent, is an implantable metallic stent. It does not appear to have any artificial intelligence or machine learning components.
• Performance Data Type: The "Performance Data" section lists physical and mechanical tests like Deployment Testing, Expansion Force Testing, Compression Force Testing, Dimensional Testing, Tensile Strength Testing, Packaging Adhesive Testing, and MR Compatibility. These are standard tests for physical medical devices and do not involve evaluating an algorithm's accuracy, sensitivity, or specificity.
• Absence of Specific Metrics: There are no mentions of metrics like sensitivity, specificity, AUC, F1-score, or any other performance indicators typically associated with AI/ML devices.
• No Reference to Ground Truth or Expert Adjudication: The concept of "ground truth," expert consensus, or adjudication methods is irrelevant for the type of device and testing described in this document.

In summary, the provided text describes a medical device clearance process for a physical esophageal stent and does not contain the information requested about acceptance criteria and studies for an AI/ML-powered device.

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

The proposed Niti-S Esophageal Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a rigid, flexible, and expandable tubular device made of a Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. This device also includes the introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface of the duct to establish patency.

The provided text is a 510(k) summary for the Niti-S Esophageal Stent, focusing on its substantial equivalence to predicate devices. It describes the device, its intended use, and technological characteristics. However, it does not contain the detailed performance data or study information required to fill out the requested table and answer many of your questions.

Specifically, this document is a regulatory submission for premarket notification, which often relies on demonstrating substantial equivalence to existing devices rather than extensive new clinical trials or detailed performance studies with acceptance criteria in the same way an AI/ML device might.

Here's what can be extracted and what cannot:

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

The document states: "Laboratory testing regarding characteristics was performed on the Niti-S Esophageal Stent to verify its safety and performance." and "A biocompatibility assessment was performed on the patient contact materials." However, it does not provide any specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or a specific metric) or the reported performance metrics (e.g., actual values from tests like radial force, fatigue, etc.).

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

This information is not provided in the document. The general statement "Laboratory testing regarding characteristics was performed" does not specify sample sizes or data 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)

This information is not provided. The document describes physical device testing (laboratory testing and biocompatibility), not studies involving expert evaluation to establish ground truth for a test set in the way an AI/ML device would require.

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

This information is 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

This information is not provided. This device is an esophageal stent, not an AI-powered diagnostic or assistive tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

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

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

For a physical medical device like an esophageal stent, "ground truth" would typically relate to predefined engineering specifications, material properties, and biological compatibility standards. The document mentions "Laboratory testing regarding characteristics" and "biocompatibility assessment," implying that the device was evaluated against these types of established standards, but it does not explicitly detail the "type of ground truth" in a way that aligns with AI/ML device evaluations.

8. The sample size for the training set

This is not applicable. This document is for a physical medical device and discusses laboratory testing and biocompatibility, not an AI/ML model that requires a training set.

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

This is not applicable.

In summary:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and general safety/performance statements from laboratory testing and biocompatibility. It does not provide the detailed performance metrics, study designs, expert involvement, or AI-specific information requested in your prompt. This type of submission generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than presenting novel clinical trial data with specific acceptance criteria and ground truth establishment, as would be expected for a new AI/ML device.

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