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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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