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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 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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