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The LumenCare Azure is intended for intraluminal brachytherapy and is used for treatment of the lung or other lumen, e.g. bronchus and bile duct.

The LumenCare Azure is designed to fit in the working channel of an endoscope.

The LumenCare Azure is a modification of the Lumencath Applicator Set. It is intended for intraluminal brachytherapy and is used for treatment of the lung and any lumen that allow the insertion of this flexible applicator, e.g. bronchus and bile duct. The applicator consists of a flexible thin catheter and accessories that assist during applicator placement, imaging and treatment. The catheter fits in the working channel of an endoscope. This way, the catheter can be positioned into the treatment area under direct visual control.

The catheter of the LumenCare Azure can be delivered in three variants. These variants only differ in dimensions, i.e. catheter diameter (outer diameter and inner diameter) and total length of the catheter.

The devices are used as accessories to Nucletron afterloaders.

The provided text describes a 510(k) submission for a medical device and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, study methodologies, or performance metrics in a way that allows for a direct answer to the requested table and study details.

The document states: "Bench testing (similar to bench testing done to the Legally Marketed Device) shows that the device meets its performance requirements, and that the device performance is equivalent to the Lumencath Applicator Set." This indicates that some form of testing was conducted to demonstrate equivalence, but the specifics are not provided.

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:

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: The document only vaguely states that "the device meets its performance requirements, and that the device performance is equivalent to the Lumencath Applicator Set." No specific quantitative or qualitative performance metrics are provided.

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

• Sample Size: Not specified.
• Data Provenance: Not specified.
• Retrospective or Prospective: Not specified.

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 / Not mentioned. The document refers to "bench testing," which typically does not involve expert readers establishing ground truth in the same way as studies involving image interpretation.

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

• Not applicable / Not 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:

• No, an MRMC comparative effectiveness study was not done. The device is an intraluminal brachytherapy applicator, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable / Not mentioned. This device is a physical medical instrument, not an algorithm.

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

• Not explicitly stated for the "bench testing." For a physical device, ground truth would typically relate to physical properties, mechanical integrity, material performance, and functional tests against specified engineering requirements.

8. The sample size for the training set:

• Not applicable / Not mentioned. This device is a physical medical instrument, not an AI algorithm requiring a training set in the conventional sense.

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

• Not applicable / Not mentioned.

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