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The BD Liverty™ TIPS Access Set is indicated for percutaneous transjugular liver access during diagnostic and interventional procedures.

The BD Liverty™ TIPS Access Set consists of an introducer sheath, a steerable cannula, a needle, a 5F catheter, a 10F dilator, and a 12F dilator. This device is intended for percutaneous transjugular liver access during diagnostic and interventional procedures.

The curve at the distal end of the TipsStar™ steerable cannula can be adjusted by the operator in-situ, by turning the orange knob at the end of the cannula to achieve the optimal cannula curve angle. Before introduction of the needle into the cannula, the bright beige 5F catheter must be slid over the needle. This assembly is introduced as one unit through the cannula. The operator then thrusts the needle / 5F catheter assembly through the liver parenchyma and into the portal vein to create the shunt. The introducer sheath is then advanced until it is positioned across the parenchymal tract. Following completion of diagnostic or interventional procedures, such as placement of a TIPS stent, the introducer sheath is removed.

The provided text describes a medical device submission (K221440) for the Liverty™ TIPS Access Set and its comparison to a predicate device. However, this document primarily focuses on demonstrating substantial equivalence through technological comparison and performance testing against predetermined acceptance criteria, rather than a clinical study evaluating diagnostic or prognostic performance of an AI/ML device.

Therefore, many of the requested criteria (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information) are not applicable or not detailed in this type of FDA 510(k) summary for a physical medical device.

I can, however, extract the acceptance criteria related to the device's physical and functional performance, and indicate that the study implicitly "proves" the device meets these criteria by stating that "All test results met the acceptance criteria, where applicable, or demonstrated that the device is biocompatible" and "Non-clinical testing demonstrated that the subject device, the Liverty™ TIPS Access Set, is as safe and effective as the legally marketed predicate device".

Here's the information that can be extracted based on the provided text, formatted to address your request where possible:

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

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

• Sample Size for Test Set: The document does not specify the sample sizes (e.g., number of devices or components) used for each individual test. It mentions "tests were performed on all device components of the subject device or on representative devices" for biocompatibility.
• Data Provenance: Not specified, as these are non-clinical device performance tests, not patient data 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. This is not a study assessing diagnostic or prognostic performance with expert ground truth. The "ground truth" for these tests would be the established engineering specifications and performance standards ("predetermined acceptance criteria").

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

• Not applicable. This is not a study involving expert review or adjudication of clinical cases.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is not an AI/ML device.

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

• No, a standalone algorithm performance study was not done. This is a physical medical device.

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

• The "ground truth" here is the predetermined acceptance criteria based on applicable standards, guidance documents (e.g., FDA guidance documents on non-clinical testing), test protocols, and internal risk assessment procedures. For biocompatibility, it's meeting ISO 10993-1.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires training data.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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