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

The Alveolus AERO DV™ Tracheobronchial Stent System described in this Notice consists of the exact same stent as the AERO™ predicate stent (K082284) but with an alternate delivery system. The Direct Visualization (DV) delivery system of AERO DV™ allows the physician to use a bronchoscope to directly view the stent as it is being positioned and deployed at the tarqet implant site. This direct visualization is made possible with a slightly larger delivery catheter lumen that allows passage of a flexible bronchoscope through the delivery catheter.

The provided text describes a medical device called the Alveolus AERO DV™ Tracheobronchial Stent System, which is a stent used to treat tracheobronchial strictures. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about acceptance criteria and a dedicated study to prove that the device meets those criteria.

Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance studies, and training set information is not available in the provided document.

The document primarily states:

• The AERO DV™ Tracheobronchial Stent System uses the exact same stent as a predicate device (AERO™ K082284) but with an alternate delivery system (Direct Visualization (DV) delivery system).
• The delivery system allows direct visualization using a bronchoscope.
• Substantial equivalence is claimed based on:
  • Using the same stent as K082284.
  • Materials meeting biocompatibility requirements of the FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" document.
  • Same indications for use.
  • Same principle of operation as the AERO DV™ Tracheobronchial Stent System predicate device (K071604).
• Physical test results for the delivery system were performed as specified in the FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" document (April 28, 1998). These tests "demonstrate that the device is suitable for its indicated use." Specific acceptance criteria or reported performance from these tests are not detailed.

In summary, the document asserts that the device meets regulatory requirements through substantial equivalence, supported by physical testing of the delivery system and biocompatibility data. However, the specific, quantitative acceptance criteria and detailed results of performance studies are not provided.

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The Alveolus AERO™ Tracheobronchial Stent Technology System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Alveolus AERO™ is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane membrane and is self-expanding. The stent expansion results from the physical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration (2mm for bronchus stent sizes and 3mm for tracheal stent sizes). The stent ends are slightly vaulted inwardly in order to minimize possible airway injury from the stent edges. 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 provided text is a 510(k) summary for the Alveolus AERO™ Tracheobronchial Stent Technology System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study that establishes acceptance criteria and proves device performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.

The document primarily covers:

• Device Description: Details about the stent's components, materials (nitinol, polyurethane), design (self-expanding, slightly larger diameter ends, vaulted ends, constant length), and features (virtually no foreshortening).
• Intended Use/Indications: Treatment of tracheobronchial strictures produced by malignant neoplasms.
• Substantial Equivalence: Listing predicate devices (Alveolus TB-STS™, Boston Scientific Ultraflex™, Rusch International Polyflex, Novatech S.A. Endoxane®) and asserting equivalence based on similar applications and established material history.
• Regulatory Information: Classification (Class II), product code (JCT), and a warning regarding its use in the vascular system.

The document does not describe any specific clinical study conducted to establish acceptance criteria or demonstrate performance of the AERO™ Tracheobronchial Stent through quantitative metrics (e.g., success rates, complication rates, flow improvements) against defined criteria. The approval is based on substantial equivalence to existing devices, implying that their established safety and effectiveness profiles are sufficient.

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The Alveolus ALIMAXX-E™ Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors and for occlusion of esophageal fistulae.

The Alveolus ALIMAXX-E™ Esophageal Stent System is comprised of two components: the completely covered, self-expanding Nitinol stent and the delivery system. The ALIMAXX-E™ Esophageal Stent System is available in several diameters and lengths. The single-patient-use components of the ALIMAXX-E™ Esophageal Stent System are provided non-sterile.

The provided document is a 510(k) summary for a medical device (ALIMAXX-E™ Esophageal Stent System) seeking substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating that a modified device is as safe and effective as a previously cleared device, primarily through performance testing and comparison of technological characteristics. It does not include a clinical study with acceptance criteria and reported device performance in the way a de novo or PMA submission might.

Therefore, I cannot directly extract the table of acceptance criteria and reported device performance that would typically come from a clinical trial demonstrating efficacy against specific endpoints. Similarly, information such as sample sizes for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and training set details are not present in this 510(k) summary because it is not a study of a new AI/software device or a clinical trial of a novel therapy.

Instead, the document focuses on demonstrating substantial equivalence through:

• Comparison of technological characteristics: Materials, biocompatibility, performance properties, sterilization, and packaging are compared to the predicate device.
• Physical test results: These were performed to show that the modified device performs similarly to the predicate.
• Biocompatibility test results: These were conducted according to FDA guidance.

Here's a breakdown of what can be inferred or directly stated from the document, and what is explicitly missing due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (Inferred): For a 510(k) submission seeking substantial equivalence for a physical device modification, the "acceptance criteria" are not reported as specific clinical endpoints. Instead, they are implicitly related to demonstrating that the modified device's performance (mechanical, material, biological) is as good as or equivalent to the predicate device. This means the modified device must:
  • Maintain lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.
  • Occlude esophageal fistulae.
  • Exhibit comparable physical properties (e.g., radial force, flexibility, fatigue resistance, deployment characteristics) to the predicate.
  • Have equivalent or acceptable biocompatibility.
• Reported Device Performance: The document states: "Physical test results were performed and biocompatibility test results included tests recommended in FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses" (issued on April 28, 1998)." The specific quantitative results of these tests are not provided in this summary. The conclusion is that these tests support substantial equivalence.

Study Information (As per the provided 510(k) summary):

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to physical and biocompatibility testing in a lab setting, not a clinical "test set" in the context of an AI/diagnostic study. The provenance of material or device samples for physical testing is not specified.

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 expert consensus, is not relevant for this type of submission which focuses on device engineering and biological performance testing.

4. Adjudication method for the test set: Not applicable. No human expert adjudication of clinical outcomes is 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: Not applicable. This is a physical medical device, not an AI or diagnostic imaging device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical and biocompatibility testing, the "ground truth" would be the established engineering specifications for the predicate device, and the relevant ISO/ASTM standards for material properties and biological safety.

8. The sample size for the training set: Not applicable. There is no AI algorithm or machine learning model described that would require a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) pertains to a physical medical device modification seeking substantial equivalence and therefore does not contain the detailed clinical study information relevant to software/AI devices or new clinical indications that your questions imply. The "study" here consists of engineering tests and biocompatibility assessments to confirm the modified device's equivalence to a cleared predicate.

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The Alveolus, ALIMAXX-B™ Uncovered Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The ALIMAXX-B Uncovered biliary stent is a sterile, single-use, self-expanding Nitinol stent that is supplied with the stent pre-loaded on the delivery catheter. The delivery device is available for endoscopic placement (working length is 185 cm), and transhepatic placement (working length 80 cm).

The provided text is a 510(k) summary for the ALIMAXX-B™ Uncovered Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a specific study proving the device meets them.

The submission refers to "physical test results for the delivery system as specified in the FDA 'Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents' document (February 5, 1998)" to demonstrate that the device is suitable for its intended use. However, these specific tests and their acceptance criteria are not directly stated in the provided text, nor are the detailed results of such tests.

Therefore, much of the requested information cannot be extracted from the given document.

Here's a breakdown of what can and cannot be answered based only on the provided text:

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

• Cannot be provided based on the given text. The document states that physical test results were conducted "as specified in the FDA 'Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents' document (February 5, 1998)" but does not list these specific criteria or the reported performance values.

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

• Cannot be provided based on the given text. The document does not describe a clinical study or a test set in the context of device performance. It only mentions "physical test results for the delivery system."

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 / Cannot be provided. There's no mention of a clinical test set or ground truth establishment by experts in the context of evaluating device performance in the provided document.

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

• Not applicable / Cannot be provided. No clinical test set where adjudication would be relevant is 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

• Not applicable. This device is a physical medical stent, not an AI-assisted diagnostic tool. An MRMC study is not relevant to its evaluation.

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

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

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

• Not applicable / Cannot be provided. No clinical ground truth establishment is described for device performance. The "ground truth" for physical device performance would typically be defined by engineering specifications and validated through bench testing, which is referred to but not detailed.

8. The sample size for the training set

• Not applicable. The device is a physical stent; the concept of a "training set" is not relevant here as it would be for an AI/ML device.

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

• Not applicable. See point 8.

Summary based on the provided text:

The submission for the ALIMAXX-B™ Uncovered Biliary Stent System demonstrates "substantial equivalence" to predicate devices (Bard® LUMINEXX™, Cook® Zilver™, ABSOLUTE™ Biliary Self-Expanding Stent). The safety and effectiveness are supported by "summaries of physical test results for the delivery system as specified in the FDA 'Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents' document (February 5, 1998)." However, specific acceptance criteria and the detailed results of these tests are not included in this 510(k) summary. The document does not describe any human-observer performance studies or data collection from patient cohorts in a way that would require statistical sample sizes, expert ground truth, or adjudication methods for performance evaluation.

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

The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane membrane and is selfexpanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration. The stent ends are slightly vaulted inwardly in order to minimize possible airway injury from the stent edges. 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Alveolus AERO™ Tracheobronchial Stent System:

Based on the provided K062511 510(k) summary and FDA letter, there is no specific information detailing a study with acceptance criteria and reported device performance in the format of a table as requested for an AI/CADe device.

The document describes a medical device, a tracheobronchial stent, not an AI/CADe system. Therefore, many of the requested elements pertaining to AI/CADe studies (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable or present in this submission.

However, I can extract the relevant information that is present and explain why other requested details are absent for this type of medical device submission.

Analysis based on a Medical Device (Tracheobronchial Stent) Submission:

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

The submission for the Alveolus AERO™ Tracheobronchial Stent System does not include a table of acceptance criteria and reported device performance in the context of an AI/CADe study. Instead, a 510(k) submission for a non-AI medical device focuses on demonstrating substantial equivalence to predicate devices. This involves comparing technological characteristics, intended use, and performance data from studies (often non-clinical or limited clinical, if required for a modified device).

The document states:

• "The 510(k) Notice references a report of a study conducted under IDE G040202 that was completed to demonstrate safety and efficacy of the modified device."
• "The materials from which the Alveolus device is fabricated have an established history of use in clinical applications, and the devices produced by Alveolus have been tested in accordance with applicable FDA guidelines."

This implies that the "acceptance criteria" were met through the demonstration of safety and efficacy via the IDE study and adherence to FDA guidelines for material testing and manufacturing, rather than statistical performance metrics against a defined ground truth as would be seen for an AI diagnostic device. Specific numerical performance values or statistical criteria are not detailed in this summary.

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 given 510(k) summary for the IDE study (G040202). The document only mentions "a report of a study conducted under IDE G040202 that was completed to demonstrate safety and efficacy of the modified device." It does not specify sample size, study design (retrospective/prospective), 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 applicable or provided for this type of medical device submission. Ground truth establishment by experts is typically a requirement for AI diagnostic device studies, where algorithm output needs to be compared against a definitive human interpretation. For a physical device like a stent, "ground truth" is typically established through clinical outcomes, imaging follow-up, and physiological measurements to assess safety and efficacy, often by treating physicians, not a panel of independent readers defining a "ground truth" for a test set in the AI sense.

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

This information is not applicable or provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations during ground truth establishment for AI/CADe performance 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

An MRMC comparative effectiveness study is not applicable for this medical device. MRMC studies are used to assess the impact of an AI system on human reader performance. This submission is for a physical stent, not an AI assistance system.

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 the IDE study referenced, "ground truth" for a stent would typically involve clinical outcomes data (e.g., patency of the airway, reduction of stricture, adverse events, patient symptoms, survival) assessed through clinical examination, endoscopy, and/or imaging. The document doesn't specify the exact type of outcome data used, but it states the study was "to demonstrate safety and efficacy."

8. The sample size for the training set

This is not applicable as the device is a physical stent and does not involve AI model training.

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

This is not applicable as the device is a physical stent and does not involve AI model training or a training set in that context.

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The Alveolus/Endoventions ALIMAXX-E DV™ Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors. The stent is also indicated for occlusion of esophageal fistulae.

The Alveolus/Endoventions ALIMAXX-E DV Esophageal Stent System provides an alternate method to deploy the Alveolus/Endoventions Esophageal stent. The implantable stent for the Alveolus/Endoventions ALIMAXX-E and the subject device are the same. The ALIMAXX-E DV delivery device provides a direct visualization (DV) of the stent deployment by providing a channel inside of the delivery device for a flexible endoscope. This channel allows the physician to directly visualize placement location, and deployment of the stent.

The provided text describes a medical device, the ALIMAXX-E DV Esophageal Stent System, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific acceptance criteria through a performance study against a predefined standard.

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

Here's what can be gathered and what cannot:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria or report performance metrics against such criteria. It states that "The 510(k) Notice contains summaries of physical test results for the delivery device as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998)" and "The data presented demonstrate that the device is suitable for its indicated use." However, the actual results or explicit acceptance criteria are not included in this summary.

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

• Cannot be provided. The document mentions "physical test results" but does not detail the sample size or the nature of the data (e.g., in-vitro, in-vivo, clinical, retrospective/prospective).

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):

• Cannot be provided. This type of information is not relevant to a 510(k) submission focused on mechanical device testing and substantial equivalence, and therefore is not present. "Ground truth" in the context of expert review is typically associated with diagnostic or AI performance studies, which this is not.

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

• Cannot be provided. Not applicable or 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:

• Cannot be provided. This is a medical device (stent system), not an AI diagnostic tool. MRMC studies are not relevant here.

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

• Cannot be provided. Not applicable, as this is a physical medical device.

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

• Cannot be provided. As noted above, "ground truth" as typically defined for diagnostic or AI studies is not relevant here. The "proof" for this device's suitability comes from physical testing and comparison to predicate devices, not from clinical ground truth establishment in the diagnostic sense.

8. The sample size for the training set:

• Cannot be provided. No training set is mentioned as this is not an AI/machine learning device.

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

• Cannot be provided. No training set is mentioned.

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The Endoventions ALIMAXX-E™ Esophageal Stent System is intended for maintaining esophageal lumen patency in patients with strictures caused by intrinsic and / or extrinsic malignant tumors. The stent is also indicated for occlusion of esophageal fistulae.

The Endoventions Esophageal Stent Technology System is comprised of two components: the stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is selfexpanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a larger diameter near the distal and proximal ends to minimize the possibility of the possible only near the distar and proximal strace to maintain a constant length over the entire overall stent geometry lo doclynbu to this unique design the stent has range of possible diamelers. The a facilitating the selection of the appropriate stent length.

The provided document is a 510(k) summary for the Endoventions ALIMAXX-E™ Esophageal Stent System. This document describes a medical device and its substantial equivalence to previously cleared devices. It does not contain information about studies proving the device meets acceptance criteria in the way typically expected for AI/ML device evaluations (i.e., performance metrics, sample sizes, expert ground truth, etc.).

Instead, the document focuses on:

• Device Description: The physical characteristics of the esophageal stent and its delivery system.
• Intended Use (Indications): Maintaining esophageal patency in malignant strictures and occlusion of esophageal fistulae.
• Substantial Equivalence: Comparing the device to existing predicate devices (Boston Scientific Ultraflex™ and Rusch International Polyflex Stents).
• Testing for Substantial Equivalence: Mentions "summaries of physical test results, and mechanical test results as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998)." This refers to engineering/mechanical testing, not clinical performance studies with human readers or AI.

Therefore, I cannot provide the requested information in the format of acceptance criteria and a study proving those criteria are met because such a study (as you've defined it for AI/ML devices) is not present in this 510(k) summary. The FDA's 510(k) pathway for traditional medical devices primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through bench testing, biocompatibility testing, and sometimes limited clinical data, rather than extensive performance studies with specified acceptance criteria for algorithm performance, reader improvement, or stand-alone accuracy against expert ground truth.

Disclaimer: This response is based solely on the provided text. If a detailed performance study with acceptance criteria, human reader comparisons, or AI performance metrics exists for this device, it is not included in the provided 510(k) summary.

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The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.

The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is self-expanding. The inner lumen of the expanded stent is coated with a hydrophilic polymer to improve lubricity. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration. The stent ends are slightly vaulted inwardly in order to minimize possible airway injury from the stent edges. 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 provided text is a 510(k) premarket notification for a medical device (Alveolus, TB-STS™ Tracheobronchial Stent System) and focuses on establishing substantial equivalence to previously cleared devices. It does not contain information about specific acceptance criteria or a detailed study proving the device meets particular performance metrics.

However, based on the text, I can extract information related to the device and the general approach to demonstrating its safety and effectiveness:

Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices, which implies the new device performs at least as well as the predicates for its intended use.

Study Information (Based on available text):

• Sample size used for the test set and the data provenance: Not explicitly mentioned. The document refers to "summaries of physical test results, and biocompatibility test results" but does not detail the specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The document does not describe a clinical study with ground truth established by experts. It refers to "physical test results" and "biocompatibility test results."
• Adjudication method for the test set: Not applicable. No clinical study with adjudication is described.
• 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 tracheobronchial stent system, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
• The type of ground truth used: For physical and biocompatibility testing, the "ground truth" would be established according to standard testing methodologies and regulatory guidelines (e.g., ISO standards for biocompatibility). The document states the tests were conducted "as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998)."
• The sample size for the training set: Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.
• How the ground truth for the training set was established: Not applicable. (See above)

Summary of Device and Evidence:

The Alveolus, TB-STS™ Tracheobronchial Stent System is described as a self-expanding nitinol stent, completely covered with a biocompatible polyurethane membrane, and coated with a hydrophilic polymer. Its design aims to minimize migration, airway injury, and foreshortening.

The device's safety and effectiveness were demonstrated by showing substantial equivalence to a number of previously cleared predicate devices, including:

• Alveolus, Inc. TB-STS™ Tracheobronchial Stent System [510(k) K030947]
• Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241]
• Vascular Architects, Inc. aSpire™ Covered Stent and CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544]

The submission included "summaries of physical test results, and biocompatibility test results as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998)." These tests established that the device is biocompatible and suitable for its indicated use. The materials used have an "established history of use in clinical applications."

In essence, the "study" demonstrating the device meets "acceptance criteria" is a demonstration of substantial equivalence through physical and biocompatibility testing consistent with FDA guidance, rather than a clinical trial with specific performance metrics and ground truth established by experts.

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The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.

The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is self-expanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration. The stent ends are slightly vaulted inwardly in order to minimize possible airway injury from the stent edges. 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. This feature facilitates the selection of the appropriate stent length.

The provided text is a 510(k) summary for the Alveolus TB-STS™ Tracheobronchial Stent System. While it discusses the device's design, intended use, and substantial equivalence to predicate devices, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, or ground truth establishment methods.

Therefore, I cannot directly extract the detailed table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies as requested. The document focuses on demonstrating substantial equivalence rather than presenting an efficacy study with specific performance targets.

Here's what can be inferred and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated or quantified in this document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.
• Reported Device Performance: The document mentions "an in vivo animal (porcine) study that demonstrates that the completely covered stent is removable like the silicone stent predicates up to 28 days." This is a performance characteristic, but it's not presented with specific acceptance criteria (e.g., "removable in X% of cases within Y days").

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

• The text mentions "an in vivo animal (porcine) study."
• Sample Size: Not specified.
• Data Provenance: In vivo animal (porcine) study. The country of origin is not specified but it's part of a US FDA submission.

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

• Not applicable based on the provided text. The animal study is observational for removability, not diagnostic, so a "ground truth" established by experts in the context of diagnostic accuracy is not relevant here.

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

• Not applicable. This relates to diagnostic studies with multiple readers, which is not 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 MRMC study mentioned. This device is a medical implant, 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 device is a medical implant, not an algorithm.

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

• For the animal study on removability, the "ground truth" would likely be the direct observation/outcome of whether the stent was successfully removed or not, as assessed by the researchers/veterinarians involved in the study. No mention of expert consensus, pathology, or separate outcomes data in this context.

8. The sample size for the training set:

• Not applicable. No training set for an algorithm is mentioned.

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

• Not applicable. No training set for an algorithm is mentioned.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence to legally marketed predicate devices, not a detailed clinical study report with a focus on specific performance criteria and efficacy endpoints.

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