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The Bard® memotherm-FLEXX™ Biliary Stent is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

The Bard® memotherm-FLEXX™ Biliary Stent is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard® memotherm-FLEXX™ Biliary Stent pre-loaded on a unique delivery system. This 7 Fr delivery system is compatible with a 7 Fr introducer and accepts a .035" guidewire. The Bard® memotherm-FLEXX™ Biliary Stent is available in various diameters and lengths.

The provided document is a 510(k) summary for the Bard® memotherm-FLEXX™ Biliary Stent. It primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT include a "study that proves the device meets the acceptance criteria" in the way one would describe a clinical performance study for an AI/ML device.

Instead, it describes bench testing for physical characteristics, comparing the new device to its predicate. The acceptance criteria for such a device are typically internal engineering specifications derived from the predicate device's performance, industry standards, and clinical needs. The "reported device performance" in this context refers to the results of these bench tests being comparable to the predicate.

Therefore, many of the requested fields are not applicable to the information provided in this 510(k) summary. I will answer as best as possible based on the provided text, while explicitly stating what is not available.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. The testing described is bench testing, not a clinical trial with human data.
• Data Provenance: Not applicable. The data is from internal bench testing of the physical device components.

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

• Not applicable. Ground truth for physical properties (flexibility, force, tensile strength, corrosion resistance) is established through engineering and material science standards and testing, not expert medical opinion on a dataset.

4. Adjudication method for the test set

• No adjudication method described as this is not a study involving human readers or interpretation.

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. This is a medical device (stent) 510(k) submission, not an AI/ML device. Therefore, no MRMC study, human readers, or AI assistance is relevant.

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

• No. This is a medical device (stent) 510(k) submission, not an AI/ML device.

7. The type of ground truth used

• The "ground truth" for the performance claims relates to the physical and mechanical properties of the stent and its delivery system, typically established through validated engineering test methods and material specifications. For example, force measurements, tensile strength testing, and material compatibility tests (e.g., corrosion resistance). The comparison is against the established performance of a predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The device itself (the stent) is the "product," not a software algorithm.

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

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

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