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The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The WALLSTENT® Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure which may be covered with an elastomeric polymer in selected models. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The stent's purpose is to increase or maintain the inner luminal diameter of the tracheobronchial passage. The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly that constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device, the WALLSTENT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System. The primary purpose of this 510(k) is to introduce an alternate delivery system with a reduced profile (smaller diameter). The core endoprosthesis itself appears to be the same as the predicate device (K964121).

The study described focuses on demonstrating the substantial equivalence of this new delivery system to the existing one, not on proving the clinical efficacy or diagnostic accuracy of the stent itself.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Performance: The 510(k) concludes that the new delivery system is substantially equivalent to the predicate device based on in vitro testing of deployment forces and handling characteristics, as well as design and indications for use.

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

The document mentions "in vitro testing" but does not specify the sample size for the test set. It also does not provide information on data provenance such as country of origin or whether it was retrospective or prospective, as it's an in vitro (benchtop) study, not a clinical study involving human patients.

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 or provided in the document. The study described is in vitro testing of mechanical properties and handling, not a study requiring expert clinical judgment or ground truth establishment in a diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Since the study focuses on in vitro comparisons of mechanical properties like deployment forces and handling, there would be no need for an adjudication method as seen in clinical or diagnostic studies.

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 comparative effectiveness study was not done. This document describes the substantial equivalence of a medical device's delivery system, not an AI-powered diagnostic tool. Therefore, there is no AI assistance or human reader improvement to measure an effect size for.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device (stent and delivery system), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this in vitro study would be the established mechanical performance and handling characteristics of the predicate delivery system. The new delivery system's performance metrics (deployment forces, handling) are compared against these known values to demonstrate "comparability." It's not clinical "ground truth" derived from pathology or outcomes.

8. The Sample Size for the Training Set

This information is not applicable or provided. This is not a machine learning or AI algorithm submission where training sets are relevant.

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

This information is not applicable or provided. As above, there is no training set for a machine learning algorithm.

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The Wallstent Tracheobronchial Endoprosthesis is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Wallstent Tracheobronchial Endoprosthesis with Permalume Covering is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Wallstent Tracheobronchial Endoprosthesis is intended for us in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Wallstent Tracheobronchial Endoprosthesis with Permalume Covering is indicated for use in the treatment of tracheobronchial strictures or fistulas produced by malignant neoplasms.

The Wallstent Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure which may be covered with an elastomeric polymer in selected models. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The prosthesis is offered in covered and uncovered version to allow physicians to select the most appropriate models based on their preference and individual patient condition. The stents purpose is to increase or maintain the inner luminal diameter of the tracheobronchial passage.

The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is release in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.

This 510(k) premarket notification (K980163) for the WALLSTENT® Tracheobronchial Prosthesis and Wallstent Tracheobronchial Endoprosthesis with Permalume covering does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics suitable for a table. The document is primarily a summary demonstrating substantial equivalence to previously cleared predicate devices, focusing on an alternate delivery system.

Therefore, many of the requested details cannot be extracted directly from this submission.

Here's a breakdown of what can be inferred or stated based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "Performance Data" section explicitly states that the alternate delivery system was found substantially equivalent based on in vitro and in vivo deployment testing which demonstrated comparable deployment forces and handling characteristics to the current delivery system. These are the only mentioned performance criteria from the document.

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

• Sample Size for Test Set: Not specified. The document only mentions "in vitro and in vivo deployment testing" without detailing the number of tests, devices, or animal subjects (if applicable for in vivo).
• Data Provenance: Not specified. It's an internal study conducted by Boston Scientific Corporation, likely in their research and development facilities. It does not mention country of origin or whether it was retrospective or prospective in a clinical sense.

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

• Number of Experts: Not applicable/not specified. For in vitro and in vivo deployment testing assessing physical characteristics, "ground truth" would typically come from calibrated measurement equipment and engineering standards, rather than expert consensus on diagnostic images or clinical outcomes.
• Qualifications of Experts: Not applicable/not specified.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/not specified. This type of method is usually relevant for studies involving human interpretation (e.g., radiology reads) or clinical endpoints that require review panels. For engineering performance testing, the results are typically objectively measured.

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

• MRMC Study: No. This is not an AI/imaging device. It's a medical implantable device (stent) and its delivery system.
• Effect Size of AI: Not applicable.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

• Type of Ground Truth: For the "deployment forces" and "handling characteristics," the ground truth would have been established through objective engineering measurements using calibrated equipment and established test protocols. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense. It's physical property measurement.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that context. The development and testing would involve engineering design, prototyping, and iterative testing.

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

• Ground Truth for Training Set: Not applicable. As there is no training set in the AI sense, there's no ground truth established for it. The ground truth for the product's engineering specifications would be derived from design requirements, material properties, and manufacturing standards.

In summary: The provided 510(k) focuses on demonstrating that a modified delivery system for an existing medical device (tracheobronchial stent) maintains comparable performance to predicate delivery systems based on engineering tests of deployment forces and handling. It is not a clinical study of a diagnostic device or AI algorithm, and therefore many of the requested details about acceptance criteria, ground truth, and study design are not present in this type of regulatory submission summary.

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The Wallstent® Tracheobronchial Endoprosthesis is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Wallstent Tracheobronchial Endoprosthesis with Permalume® Covering is intended for use in the treatment of tracheobronchial strictures or fistulas produced by malignant neoplasms.

The Wallstent Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure which may be covered with an elastomeric polymer in selected models. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The prosthesis is offered in covered and uncovered version to allow physicians to select the most appropriate models based on their preference and individual patient condition. The stents purpose is to increase or maintain the inner luminal diameter of the tracheobronchial passage.

The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is release in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.

The provided text is a 510(k) premarket notification summary for the WALLSTENT® Tracheobronchial Endoprosthesis, specifically addressing an alternate delivery system. This document primarily focuses on establishing substantial equivalence to a predicate device for this alternate delivery system, rather than providing detailed acceptance criteria and performance data for the endoprosthesis itself.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for the device (the endoprosthesis) is largely not present in the provided text. The document states that the alternate delivery system was found substantially equivalent based on in vitro test results demonstrating comparable deployment forces and handling characteristics to the current delivery system.

Here's a breakdown of what can be extracted about the alternate delivery system and what is missing regarding the endoprosthesis:

Information available regarding the alternate delivery system:

• Acceptance Criteria & Performance:
  • Acceptance Criteria (Implicit): The alternate delivery system should have deployment forces and handling characteristics comparable to the predicate delivery system.
  • Reported Device Performance: In vitro test results demonstrate that deployment forces and handling characteristics are comparable to the current delivery system.
  • Study Type: In vitro testing.

Missing Information (or implicitly not applicable) for the alternate delivery system and entire device (endoprosthesis):

1. A table of acceptance criteria and the reported device performance: While comparability is stated for the delivery system, specific quantifiable criteria and results are not provided for either the delivery system or the stent itself.
2. Sample size used for the test set and the data provenance: Not specified for the in vitro tests of the alternate delivery system. No information for the endoprosthesis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the testing mentioned is in vitro for the delivery system, not involving expert interpretation of patient data.
4. Adjudication method for the test set: Not applicable for in vitro testing of the delivery system.
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 (stent and delivery 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 a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the delivery system, "ground truth" seems to be the performance of the predicate delivery system in in vitro tests. For the endoprosthesis itself, the document doesn't provide this detail.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
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 WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The WALLSTENT® Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure which may be covered with an elastomeric polymer in selected models. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The prosthesis is offered in covered and uncovered versions to allow physicians to select the most appropriate model based on their preference and individual patient condition. The stent's purpose is to increase or maintain the inner luminal diameter of the tracheobronchial passage. The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.

The provided text describes a 510(k) premarket notification for the WALLSTENT® Tracheobronchial Endoprosthesis, which is a medical device. This document is a regulatory submission for market clearance and does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way an AI/ML device submission would.

The document details the device's description, indications for use, and a comparison to predicate devices to demonstrate substantial equivalence, a key concept in 510(k) submissions. It mentions modifications to existing stents (increasing wire diameter and/or number of wires to standardize relative radial force), suggesting that some testing or design changes occurred, but it doesn't provide performance metrics or the details of a study with acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. The submission is focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study against predefined acceptance criteria.

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