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The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Ultraflex Tracheobronchial Stent System is a permanently implanted expandable metal stent designed to serve as an intralumenal support to keep open the inner lumen of the tracheobronchial tree. They consist of a flexible delivery catheter preloaded with an expandable metallic stent.

The stent is an open-ended cylindrical mesh constructed from a single strand of nitinol wire. The wire is configured into a series of circumferential interwoven loops, with the number of loops being dependent on the diameter of the stent. The stent is elongated and compressed onto a plastic delivery catheter. The stent is held onto the delivery catheter by a crocheted nylon suture wrapped around the stent. The delivery catheter has a flush taper tip at the distal end, and a round hub handle at the proximal end.

The partially covered stent has a single layer of silicone that covers the midsection of the stent. Partially covered stents are available with a distal release system only. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter. The uncovered stents are available with a distal or proximal release system.

The radiopaque (RO) markers on the delivery system and stent facilitate fluoroscopic placement.

The uncovered stent has one pair of RO markers indicated the approximate locations of the margins of the deployed stent. The partially covered stent has four (4) RO markers. The outer two (2) RO markers indicate the estimated final position of the ends of the deployed stent. The inner two (2) RO markers indicate the estimated final position of the margins of the deployed stent cover.

The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The delivery system is passed over the guidewire into the tracheobronchial lumen. The stent is positioned appropriately using the RO markers for guidance under fluoroscopy and by bronchoscopic visualization of the stent.

The provided text does not describe acceptance criteria for a device performance study in the context of diagnostic accuracy, which is typically represented by metrics like sensitivity, specificity, or AUC. Instead, it describes acceptance criteria and testing for the safety of a medical device within a Magnetic Resonance (MR) environment.

Here's an analysis of the provided information based on your request, focusing on what is available:

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

The document does not explicitly state numerical acceptance criteria for each test in a table format, nor does it provide detailed quantitative results for the device performance beyond stating compliance. However, it implicitly states that the acceptance criteria are compliance with the FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021.

List of Tests Performed (as part of demonstrating compliance):

• Magnetically Induced Displacement Force: Tested per ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
• Magnetically Induced Torque: Tested per ASTM F2213, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
• Heating by Radio Frequency (RF) Fields: Tested per ASTM F2182, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging.
• Image Artifact: Tested per ASTM F2119, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.

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 tests described are "bench performance testing," implying laboratory-based evaluations of the device itself, not a study involving patient data or human subjects. Therefore, concepts like sample size for a "test set" in the context of diagnostic accuracy or data provenance (country, retrospective/prospective) are not applicable here.

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. The study described is bench testing for MR safety, not a study evaluating diagnostic performance where expert ground truth would be established.

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

This information is not provided and is not applicable, as it's a bench test, not a study with human adjudication of results.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is bench testing for MR safety. AI assistance is not relevant to this type of testing.

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

A standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The performance testing was for the physical device's safety in an MR environment.

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

The concept of "ground truth" (expert consensus, pathology, outcomes data) as it pertains to diagnostic accuracy studies is not applicable here. The ground truth for the safety testing is established by adherence to the specified ASTM standards and the FDA Guidance for MR safety, which define acceptable parameters for magnetic displacement, torque, heating, and artifact generation.

8. The sample size for the training set

This information is not provided and is not applicable. This is not an AI/algorithm-based device requiring a training set.

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

This information is not provided and is not applicable, as there is no training set mentioned or implied for this device.

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The Through the Scope Tracheal Stent System is in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The Through the Scope Tracheal Stent System consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire weaved in a tubular mesh shape. This structure may make the stent more flexible, compliant and self-expanding. The stent is fully covered with silicone membrane and a polymer coating. The Parylene N is added on the surface of silicone membrane to restrict tumor in-growth through the wire mesh. A retrieval loop made of PE&PP is threaded through the proximal and distal ends of the stent and is intended to aid in removal during the stent placement procedure. The stent has different dimension with the diameters of 10mm, 12mm, 16mm, 18mm, with the lengths of 20mm, 30mm, 40mm, 50mm, 60mm, 80mm.

The stent is deployed through the endoscopy working channel and under direct vision of endoscopy. The delivery system allows for desheathing to deploy and reposition the stent during the placement procedure. The delivery system consists of two coaxial sheaths and one inner core. The outer sheath serves to constrain the stent until being retracted during the stent deployment. The middle sheath serves to support the delivery system. The round tip acts as a guide when the delivery system enters the body. The front handle is used for deploying the stent. The seal ring, locking ring, and safe lock work to lock the device and prevent the stent from being exposed. The decoration nut connects with the back handle.

The device is supplied sterile, intended for single use only, and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.

The provided text does not describe a study that uses AI or machine learning. It pertains to a medical device (Tracheal Stent System) and its premarket notification (510(k)) to the FDA. The tests conducted are non-clinical performance tests of the physical device, its materials, and its delivery system, ensuring its safety and effectiveness.

Therefore, many of the requested points related to AI/ML model evaluation (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable to this document.

However, I can still extract the acceptance criteria and performance related to the physical device based on the information provided.

Device: Through the Scope Tracheal Stent System
Product Code: JCT
Regulation Name: Tracheal Prosthesis

Since the document does not contain information about an AI/ML model's performance, I will interpret the request in the context of the physical medical device's performance given the available information.

Acceptance Criteria and Reported Device Performance

The document states that "The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device Tracheal Stent System (OTW) cleared under K202204."

While the specific numerical acceptance criteria are not detailed in the provided text (e.g., what percentage drop in expansion force is acceptable), the document lists the types of tests conducted and affirms that the device met these criteria, thus demonstrating substantial equivalence.

Here's a table based on the information provided:

Non-Applicable Information (for AI/ML studies)

As this document describes a traditional medical device (a tracheal stent), the following points are not applicable and no information is provided for them:

2. Sample size used for the test set and the data provenance: Not an AI/ML study. Performance tests are typically done on a defined number of physical samples, but this is not a data test set in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML study involving human reader ground truth.
4. Adjudication method for the test set: Not an AI/ML study.
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 an AI/ML study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML study.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not an AI/ML study. Measurements and physical properties constitute the "ground truth" for this device.
8. The sample size for the training set: Not an AI/ML study. There is no "training set."
9. How the ground truth for the training set was established: Not an AI/ML study.

In summary, the provided document describes the non-clinical performance testing of a physical medical device (a tracheal stent) to demonstrate its substantial equivalence to a predicate device, rather than the evaluation of an AI/ML-driven medical device.

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The Tracheal Stent System (Y -Shaped) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The Tracheal Stent System (Y-Shaped) consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire by weaving in a Y shaped. This structure design can make the stent more flexible, compliant and self-expanding. The stent is integrated Y-shaped stent, which include 1 main stent, 2 branch stents, the integrated Y-shaped stent can replace three straight shape stents, and the overall design of Y-shaped stent can also be used for the expansion of the carina if there are strictures at the carina. The stent is woven from Nitinol wire. The branch stent is formed with a flange at either end. The stent is partially covered with silicone to restrict tumor in-growth through the wire mesh. To aid in visibility under fluoroscopy there are radiopaque markers at the stent. There are 3 retrieval loops at the end of stent which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.

This document describes the Tracheal Stent System (Y-Shaped) and its substantial equivalence to a predicate device. However, the provided text does not describe acceptance criteria for a study proving device performance in the context of AI/ML or diagnostic accuracy, nor does it detail a study involving human readers or ground truth derived from expert consensus, pathology, or outcomes data related to an AI/ML component.

Instead, the document focuses on the substantial equivalence of a physical medical device (a tracheal stent system) to a predicate device, as required for a 510(k) premarket notification. The "performance data" sections list various engineering and biocompatibility tests conducted on the stent and its delivery system, ensuring its safety and functionality, not its diagnostic or interpretative accuracy in an AI context.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy.
• Sample size used for the test set or data provenance in an AI/ML context.
• Number of experts or their qualifications for establishing ground truth in an AI/ML context.
• Adjudication method for a test set in an AI/ML context.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of AI assistance.
• Standalone (algorithm only) performance.
• Type of ground truth (expert consensus, pathology, outcomes data) in an AI/ML context.
• Sample size for the training set for an AI/ML model.
• How ground truth for the training set was established for an AI/ML model.

The document states:

• No animal study is included in this submission.
• No clinical study is included in this submission.

This indicates that the evaluation primarily relies on bench testing, biocompatibility testing, and comparison of technological characteristics to already approved devices, rather than a clinical trial or a study assessing human or AI diagnostic performance.

Summary of what the document does provide regarding device acceptance and performance (not AI/ML related):

The device is a Tracheal Stent System (Y-Shaped) indicated for treating tracheobronchial strictures caused by malignant neoplasms.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device TRACHEOBRONXANE™ DUMON Tracheo-bronchial Silicone Stent and reference device AERO™ Tracheobronchial Stent Technology System."

While specific numerical acceptance criteria for each test (e.g., "Deployment Force shall be X to Y N") are not listed in this summary, the document broadly indicates that the device met these criteria. The "Performance Data" section lists the types of tests conducted:

2. Sample size used for the test set and the data provenance: Not applicable. These tests are primarily bench/lab tests, not studies on patient data in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to the defined specifications and physical properties of the device, assessed through engineering and biocompatibility standards, not expert interpretation of medical images or conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

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

7. The type of ground truth used:
The "ground truth" for the performance evaluation of this physical medical device is based on engineering specifications and established international standards (e.g., ISO, ASTM standards for biocompatibility, sterility, MR compatibility, and mechanical properties). The device's performance is measured against these predetermined specifications.

8. The sample size for the training set: Not applicable (no AI/ML training involved).

9. How the ground truth for the training set was established: Not applicable (no AI/ML training involved).

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The Tracheal Stent System (OTW) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The Tracheal Stent System (OTW) consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire weaved in a tubular mesh shape. This structure may make the stent more flexible, compliant and self-expanding. The stent is partially or fully covered with silicone membrane and a polymer coating to restrict tumor in-growth through the wire mesh. A retrieval loop made of PE&PP is threaded through the proximal and distal ends of the stent and is intended to aid in removal during the stent placement procedure. To aid in visibility under fluoroscopy, there are Tantalum radiopaque markers at the body of the stent. The stent has flanges at the ends to aid in minimizing migration after

The provided text outlines the acceptance criteria and a study that demonstrates the Micro-Tech (Nanjing) Co., Ltd. Tracheal Stent System (OTW) meets these criteria for substantial equivalence to a predicate device. However, this is not a study that proves the device meets an acceptance criterion, but rather that it meets the acceptance criteria set by the predicate device.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of explicit acceptance criteria with numerical targets alongside performance results for each criterion. Instead, it states that "The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device AERO™ Tracheobronchial Stent Technology System." The "acceptance criteria" are implied by the successful completion of the listed tests in accordance with relevant standards and guidelines, demonstrating functional equivalence to the predicate.

• Skin Sensitization
• Irritation
• Acute Systemic Toxicity
• Pyrogen
• Muscle Implant
• Chemical Characterization and Biological Risk Assessment (Stent)
• Vitro Cytotoxicity
• Skin Sensitization
• Irritation (Delivery System) | Conducted in accordance with ISO 10993-1: 2009 and FDA's biocompatibility guidance. Results indicate compliance and support substantial equivalence. |
  | Device Performance | - Visual Inspection
• Dimension Testing
• Deployment Force and Deployment Accuracy Testing
• Expansion Force Testing
• Compression Force Testing
• Tensile Strength Testing
• Corrosion Testing
• Fatigue testing
• Sterility Testing | Conducted and evaluated for the subject device in consultation with "Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th, 1998". Results met acceptance criteria and support substantial equivalence. |
  | Shelf-life & Packaging | - Shelf-life testing (accelerated aging)
• Packaging integrity testing | Conducted based on ASTM F1980-16, ISO 11607-1:2019, and ISO 11607-2:2019. Two-year aging test will be performed. Results meet requirements. |
  | Sterilization Validation | - Validation of Ethylene Oxide Sterilization | Carried out in accordance with ISO 11135:2014+A1:2018. Results meet requirements. |
  | MR Compatibility | - ASTM F 2052-15 (Magnetically Induced Displacement Force)
• ASTM F2182-19e2 (Radio Frequency Induced Heating)
• ASTM F2119-07(2013) (MR Image Artifacts)
• ASTM F2213-17 (Magnetically Induced Torque)
• ASTM F2503 - 13 (Marking Medical Devices)
• FDA guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021 | Evaluated in accordance with listed ASTM standards and FDA guidance. Results demonstrate compliance and support substantial equivalence. |

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

The document does not explicitly state sample sizes for the various bench tests, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). These details are typically found in the full test reports, which are not included in this summary.

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

Not applicable. This submission is for a device, not an AI/software product that relies on expert interpretation for ground truth. The "ground truth" for the performance tests would be established by the defined parameters and methodologies of the referenced international standards and FDA guidance documents.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human reader performance.

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 submission, not an AI/software submission. No MRMC study was conducted or mentioned.

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

Not applicable. This is a medical device submission, not an AI/software submission. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

For the various performance tests (biocompatibility, mechanical performance, sterility, shelf-life, MR compatibility), the "ground truth" is defined by the acceptance limits and methodologies specified in the cited international standards (e.g., ISO 10993-1, ASTM F1980-16, ISO 11607, ISO 11135, ASTM F2052, etc.) and FDA guidance documents. These standards provide objective, measurable criteria for evaluating device properties.

8. The Sample Size for the Training Set

Not applicable. This is a medical device submission, not an AI/software submission. There is no mention of a "training set."

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

Not applicable. As above, there is no training set for an AI algorithm.

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The HANAROSTENT® TracheaBronchium (CCC) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The HANAROSTENT® Trachea/Bronchium (CCC) is a self-expanding tubular prosthesis designed to maintain patency of tracheal or/and bronchial obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery device. The self-expandable metal stent is made of nickel titaniumalloy (nitinol) wire that is fully covered with a silicone membrane and has one repositioning lasso at one end of the stent. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device and expanded in the body by pulling the outer sheath of the delivery device. The stent and delivery device are provided sterile and are intended for single use only.

The provided text describes a medical device, the HANAROSTENT® Trachea/Bronchium (CCC), and its 510(k) submission to the FDA. This document focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, biocompatibility, and bench testing.

The document does not contain information about acceptance criteria, the specific study that proves the device meets acceptance criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.

Instead, the document details physical and functional attributes of the device and compares them to predicate devices to demonstrate substantial equivalence. It confirms that the device meets certain performance benchmarks through bench testing and biocompatibility standards.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance based on studies, nor can I provide details about sample sizes, expert involvement, or algorithm-specific metrics as this information is not present in the provided text.

The information that can be extracted relevant to performance and testing is as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit "acceptance criteria" for clinical performance are not stated in the document, and no clinical study results are provided, a table like the one requested cannot be fully generated. The document only lists types of bench tests performed.

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

• The document states: "No clinical performance data is submitted in this 510(k)." and "No animal performance data is submitted in this 510(k)." Therefore, there is no test set of patient data described.
• The only tests mentioned are bench tests and biocompatibility tests, typically performed on a certain number of device units or material samples. The specific sample sizes for these bench and biocompatibility tests are not provided in this document.
• Data provenance is not applicable for a clinical or animal test set, as none were submitted.

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

• Not applicable, as no clinical test set with ground truth established by experts is mentioned.

4. Adjudication method for the test set:

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, 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), not an AI algorithm for diagnostic imaging, and therefore an MRMC study is not relevant to its type of premarket submission.

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

• Not applicable. This is a physical medical device (stent), not an algorithm.

7. The type of ground truth used:

• For the biocompatibility and bench tests, the "ground truth" would be established by industry standards (e.g., ISO, USP) and pre-defined specifications for material properties, mechanical performance, and biological response. These are not "expert consensus, pathology, or outcomes data" in the context of clinical evaluation.

8. The sample size for the training set:

• Not applicable. As this is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.

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

• Not applicable, as there is no training set for an AI algorithm.

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The Merit ENDOTEK AEROmini™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The MERIT ENDOTEK AEROmini Tracheobronchial Stent System is comprised of two components: the radiopaque self-expanding nitinol stent and the delivery system. The stent is completely covered with a biocompatible polvurethane membrane. The stent expansion results from the physical properties of the metal and the proprietary geometry. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length. The stent is deployed endoscopically with a dedicated delivery system with or without the aid of fluoroscopic imaging. The delivery system consists of two coaxial sheaths. The exterior sheath serves to constrain the stent until the sheath is retracted during deployment. The stent remains constrained by the delivery system until the trigger is pulled beyond the white deployment threshold mark located between the trigger and hand grip. This feature allows for repositioning of the stent proximally. A radiopaque tip and marker on the inner shaft aid the operator in determining stent position in relation to the deployment threshold mark, where repositioning or en bloc withdrawal is no longer possible. The inner sheath of the delivery system contains a central lumen that will accommodate a 0.035" guide wire. This feature is designed to allow guidance of the delivery system to the intended implant site while minimizing the risk of airway injury from the delivery system tip.

The stent and delivery system are provided sterile using ethylene oxide (EO) process.

This document describes a 510(k) premarket notification for the AEROmini Tracheobronchial Stent System, manufactured by Merit Medical Systems, Inc. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K140382) to allow the device to be marketed.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly numerical targets in the provided text. Instead, the document states that the device "met the standards' established acceptance criteria applicable to the substantial equivalence of the device" and "met the predetermined acceptance criteria applicable to the performance of the device" for various tests. The general acceptance criterion is demonstrating that the new AEROmini device, with its new sizes and a new delivery system, performs equivalently to the predicate device and national/international standards without raising new questions of safety or effectiveness.

Below is a table summarizing the types of tests conducted (representing the indirectly stated acceptance criteria categories) and the reported device performance. No specific numerical thresholds or performance metrics are provided in this summary.

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

The document does not specify the sample sizes used for each individual test. It lists a "battery of tests" that were performed based on recognized performance standards and guidance. The provenance of the data (e.g., country of origin) is not mentioned beyond the fact that it was conducted by the manufacturer, Merit Medical Systems, Inc., for a U.S. FDA submission. The nature of these tests (mechanical, biocompatibility, sterilization, etc.) implies laboratory or bench testing rather than human clinical data. Therefore, it is not retrospective or prospective in the clinical trial sense.

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

This information is not applicable and not provided in the document. The "ground truth" for these engineering and materials tests is established by adhering to widely accepted international and national standards (e.g., ISO, ASTM, FDA guidance) and their specified methodologies, rather than expert consensus on individual cases. The manufacturers' internal experts and testing personnel would perform these tests and interpret the results against the standard criteria.

4. Adjudication method for the test set:

This is not applicable as the tests are primarily objective measurements against defined standards, not subjective interpretations requiring adjudication.

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

This is not applicable. The device described, the AEROmini Tracheobronchial Stent System, is a physical medical device (a stent and its delivery system), not an AI-powered diagnostic or assistive 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 stent system, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the performance evaluations is based on adherence to:

• Recognized Performance Standards: e.g., ISO 11135:2014, ASTM D4169-16, ASTM F2052-15, ISO 10993 series.
• FDA Guidance: Specifically, "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses, April 28, 1998" and "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995."
• Internal specifications and risk analysis: "Performance testing was conducted based on the risk analysis."

These documents and standards define acceptable methods, materials properties, and performance limits for such devices.

8. The sample size for the training set:

This is not applicable. The device is a physical medical device and does not involve AI algorithms that require training sets.

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

This is not applicable.

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The WALLSTENT™ RP Endoprosthesis and WALLSTENT™ Endoprosthesis Tracheobronchial are indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial are comprised of two components: The implantable metallic stent and the UNISTEP Plus delivery system. The stent is composed of biomedical superalloy wire, braided in a tubular mesh configuration. This design configuration results in a stent that is flexible, compliant, and self-expanding. The delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. Small stent sizes (5mm-12mm) may have a radiopaque core to improve radiopacity. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in (0.89mm) guidewire.

This document describes the regulatory clearance for the WALLSTENT™ RP Endoprosthesis Tracheobronchial and WALLSTENT™ Endoprosthesis Tracheobronchial. This is a medical device, specifically a self-expanding stent used to treat tracheobronchial strictures caused by malignant neoplasms.

The submission is a 510(k) premarket notification, which means the manufacturer is demonstrating that the device is substantially equivalent to a legally marketed predicate device. Therefore, the "study" described is primarily focused on demonstrating this substantial equivalence, particularly regarding MRI compatibility, rather than a clinical study evaluating the device's efficacy against clinical acceptance criteria in a human population.

Given the nature of the document (a 510(k) summary), many of the requested details about acceptance criteria for device performance, ground truth establishment, expert adjudication, multi-reader multi-case studies, and training set information are not directly applicable or available. The study in question is a non-clinical bench test study for MR compatibility.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria for clinical performance (e.g., success rates, complication rates) or an AI model's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device and safety, particularly regarding MR compatibility.

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

The document describes non-clinical bench testing. Therefore, the concept of a "test set" in the context of patient data or clinical images does not apply. The "sample size" would refer to the number of physical devices or components tested in the lab. This specific number is not explicitly stated in the provided text, but the testing was for MR compatibility. The data provenance is from bench testing conducted by Boston Scientific Corporation.

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

Not applicable. The study is non-clinical bench testing for MR compatibility, not a study involving medical images needing expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical bench test, not a study involving human interpretation or adjudication of medical data.

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

No. This document describes a 510(k) submission for a physical medical device, not an AI or imaging software. The study performed was non-clinical bench testing for MR compatibility.

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

Not applicable. This is not an AI or algorithm-based device.

7. The Type of Ground Truth Used

For the MR compatibility testing, the "ground truth" would be established by physical measurements and adherence to the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." This involves objective physical testing for parameters such as magnetically induced displacement force, torque, and heating, and assessment of image artifact.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or algorithm-based device, so there is no "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 submission.

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The MERIT ENDOTEK AEROmini Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The MERIT ENDOTEK AEROmini Tracheobronchial Stent System is comprised of two components: the radiopaque self-expanding nitinol stent and the delivery system. The stent is completely covered with a biocompatible polyurethane membrane. The stent expansion results from the physical properties of the metal and the proprietary geometry. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length. The stent is deployed endoscopically with a dedicated delivery system with or without the aid of fluoroscopic imaging. The delivery system consists of two coaxial sheaths. The exterior sheath serves to constrain the stent until the sheath is retracted during deployment. The stent remains constrained by the delivery system until the trigger is pulled beyond the white deployment threshold mark located between the trigger and hand grip. This feature allows for repositioning of the stent proximally. In addition, the procedure can be aborted and the entire system can be withdrawn en bloc at any time before the trigger is pulled beyond the white deployment threshold mark located between the trigger and hand grip. A radiopaque tip and marker on the inner shaft aid the operator in determining stent position in relation to the deployment threshold mark, where repositioning or en bloc withdrawal is no longer possible. The inner sheath of the delivery system contains a central lumen that will accommodate a 0.035" guide wire. This feature is designed to allow guidance of the delivery system to the intended implant site while minimizing the risk of airway injury from the delivery system tip.

The provided text describes the regulatory clearance of the AEROmini™ Tracheobronchial Stent System, focusing on its substantial equivalence to a predicate device rather than a study proving the device meets predefined acceptance criteria for AI/algorithm performance. Therefore, most of the requested information regarding AI/algorithm performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance, is not available in the given document.

However, the document does list the acceptance criteria in general terms, and states that studies were conducted to meet these criteria, thereby demonstrating substantial equivalence.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable as this document does not describe an AI/algorithm-based study. The performance testing refers to physical and material properties of the medical device itself. No specific sample sizes for these tests are provided in the summarized information beyond noting that "a battery of tests was performed."
• Data provenance: Not specified. This typically refers to laboratory testing of the physical device components and system.

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

• Not applicable. Ground truth in the context of AI/algorithm performance is not relevant here. The "ground truth" for the device's performance is established by recognized performance standards and guidance documents (e.g., ISO, ASTM, FDA guidance), against which the device's physical and biological properties are measured.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods are typically used in clinical studies or expert review processes for AI algorithms. Here, device performance is measured against objective technical standards.

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 document describes a traditional medical device (stent) and its physical, mechanical, and biological performance characteristics, not an AI or imaging diagnostic device that would involve human readers.

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

• No. Not an AI/algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is based on recognized performance standards and guidance documents (e.g., FDA Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prosthesis, ISO, and ASTM standards) which define the expected physical, mechanical, and biological properties for tracheal prostheses.

8. The sample size for the training set:

• Not applicable. No AI/algorithm training set.

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

• Not applicable. No AI/algorithm training set.

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The BONASTENT® Tracheal/Bronchial Stent System is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms.

The BONASTENT® Tracheal/Bronchial (BTB) is a self-expanding tubular prosthesis designed to maintain patency of tracheobronchial strictures caused by malignant tumors. The stent is made of Nitinol wire and is weaved using a hook & cross wire construction; a silicon membrane covers the stent and is designed to prevent stent migration. Stent sizes range in diameter from 10mm to 20mm and in length from 50mm to 80mm.

The BONASTENT® Tracheal/Bronchial is available on two types of delivery devices. The Y-Shape Handle Delivery Device is used for stents with an outer diameter of 10Fr and less. The I-Shape Handle Delivery Device which is used for stents with an outer diameter larger than 10F.

The provided text describes the 510(k) Summary for the BONASTENT® Tracheal/Bronchial device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with explicit acceptance criteria and device performance metrics in the typical sense of a clinical trial. However, it does outline performance characteristics compared to its predicate.

Here's an analysis based on the information provided, framed to address your request for acceptance criteria and supporting studies where possible, while noting limitations due to the nature of a 510(k) summary for a stent:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (a tracheal/bronchial stent), the "acceptance criteria" are implicitly defined by demonstrating equivalence to a legally marketed predicate device (AERO Tracheobronchial Stent System). The performance data supplied are comparative benchmarks rather than direct acceptance criteria against a defined threshold.

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

The "test set" in this context refers to the samples used in bench testing.

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for the validation and comparative testing performed on the stent models (e.g., 10x20 and 20x80 stents) and deployment systems.
• Data Provenance: The studies are described as "Bench Testing" and "in-vitro tests," meaning they were conducted in a laboratory environment. There is no information regarding country of origin for the data or whether it's retrospective or prospective.

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

Not applicable for this type of submission. This document pertains to bench testing and substantial equivalence, not a clinical study requiring expert ground truth for interpretation of medical data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to clinical data review, typically by medical experts for diagnoses or outcomes, which is not part of this bench testing summary.

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) submission, not an AI diagnostic or assistive device.

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

Not applicable. This is a medical device (stent) submission, not an algorithm.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" is defined by the physical properties measured against established engineering and material standards, or by direct comparison to the predicate device's measured performance. For instance, expansion force measurements are compared directly to the predicate's measurements. Biocompatibility relies on standardized tests.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable.

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The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Ultraflex Tracheobronchial Stent Systems are permanently implanted expandable metal stents designed to serve as an intralumenal support to keep open the inner of the tracheobronchial tree. They consist of a flexible delivery catheter preloaded with an expandable metallic stent.

The stent is an open-ended cylindrical mesh constructed from a single strand of nitinol wire. The wire is configured into a series of circumferential interwoven loops, with the number of loops being dependent on the diameter of the stent. The stent is elongated and compressed onto a plastic delivery catheter. The stent is held onto the delivery catheter by nylon suture wrapped around the stent. The delivery catheter has a flush taper tip at the distal end, and a round hub handle at the proximal end.

The covered stent has a single layer of translucent polyurethane that covers the midsection of the stent.

Covered stents are available with a distal release system only. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter.

The radiopaque (RO) markers on the delivery system and stent facilitate fluoroscopic placement.

The covered stent has four RO markers. The outer two (2) RO markers indicate the estimated final position of the ends of the deployed stent. The inner two (2) RO markers indicate the estimated final position of the margins of the deployed stent cover (Figure 1B).

The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The delivery system is passed over the guidewire into the tracheobronchial lumen. The stent is positioned appropriately using the RO markers for guidance under fluoroscopy and by bronchoscopic visualization of the stent.

The stent is deployed by holding the handle hub in the palm of one hand, and grasping the finger ring with the other hand. By retracting the finger ring the suture crochet knots are unraveled in a circular manner along the length of the stent, gradually deploying the stent. When using the proximal release system, stent deployment begins from the upper (proximal) end of the delivery system, and continues to release toward the tip of the delivery system (distally) as the entire suture unravels. When using the distal release system, stent deployment begins from the lower (distal) end of delivery system, and continues to release towards the operator (proximally) as the entire suture unravels.

After the stent is completely released, and the nylon suture has been completely removed, the delivery system catheter can be removed.

The provided document is a 510(k) premarket notification for a medical device (Ultraflex™ Tracheobronchial Partially Covered Stent System). It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

However, this document does not contain information about a study based on statistical performance metrics (like accuracy, sensitivity, specificity, or AUC) or human reader performance. The "Performance Data" section (Section 7) on page 5 details in-vitro testing and compliance with various standards for aspects like dimensions, fatigue, compression, deployment accuracy, magnetic resonance, corrosion, sterility, pyrogenicity, and biocompatibility.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to a statistical study, nor can I answer questions 2 through 9, as these pertain to information that is not present in the provided text.

The information provided only demonstrates that the device ("Ultraflex™ Tracheobronchial Partially Covered Stent System") met required specifications for a series of in-vitro tests and complies with various safety and material standards. This is the basis for its substantial equivalence determination by the FDA for market clearance.

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