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as a palliative treatment for malignant neoplasms in the biliary tree

IntraTherapeutics. Inc. device is a balloon expandable stainless steel stent with an open lattice design. The ITI Stent is provided unmounted to be manually crimped onto a noncompliant PTA balloon catheter of choice by the physician. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.

The provided text is related to a 510(k) submission for a medical device called the "ITI Stent," a biliary catheter. This documentation focuses on establishing substantial equivalence to a predicate device based on material, intended use, and technological characteristics, supported by bench testing. This type of submission does not typically involve clinical trials with human subjects, AI algorithms, or detailed performance metrics as would be required for software-as-a-medical-device (SaMD) or clinical diagnostic devices.

Therefore, many of the questions you've asked (e.g., sample size for test set, number of experts, MRMC studies, standalone algorithm performance, AI assistance) are not applicable to this type of device submission as described in the provided text. The device is a physical medical device (a stent), not a diagnostic algorithm or AI software.

Here's a breakdown of what can be extracted or inferred from the provided information, and where the information is not applicable:

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

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

• Not Applicable. The study described involves bench tests on the device itself, not clinical data or patient test sets. Therefore, there is no "sample size" of patients or data, nor data provenance in the context of clinical studies.

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. As this is a physical medical device and not a diagnostic system, there is no "ground truth" to be established by experts from patient data in the context of this 510(k) summary. The "ground truth" for the device's characteristics would be established by engineering specifications and material standards, verified through testing.

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

• Not Applicable. As there is no clinical test set requiring expert interpretation, no adjudication method is relevant.

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 (stent), not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.

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

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

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

• The "ground truth" for this device's performance is based on engineering specifications, material science standards, and established bench testing protocols designed to assess mechanical properties, biocompatibility, and pyrogenicity. These are compared to the predicate device to demonstrate substantial equivalence.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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