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The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers are intended for delivery of the stent to the pancreatic duct (PD):
• Used to drain pancreatic ducts

The Advanix™ Pancreatic Stent and NaviFlex™ RX Pancreatic Delivery System and Pushers is a plastic pancreatic stent designed for the delivery of the stent to the pancreatic duct and used to drain pancreatic ducts.

The pancreatic stents are provided in straight or single pigtail shape. The straight shape stents have trailing barbs and/or leading barbs depending on application, in rounded or tapered leading end tip to facilitate access through papilla, and a rounded trailing end or about the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on application. Some stents have lateral drainage holes in the pigtails, a tapered or rounded leading end tip, and a rounded trailing end. All stents have either an endoscopic or fluoroscopic marker, or both on the trailing or leading end of the stent to assist with depth of placement in the pancreatic duct. The location and presence of an endoscopic or fluoroscopic marker is dependent on the length and diameter size of the stent. Some codes have side port holes in the body of the stent.

I regret to inform you that the provided text is a U.S. FDA 510(k) clearance letter and summary for a medical device (Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers).

This type of document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance bench testing and biocompatibility.

Crucially, this document does not contain information about clinical studies with human patients, nor does it establish device performance against specific acceptance criteria in a clinical setting.

Therefore, I cannot extract the information you requested regarding:

1. A table of acceptance criteria and the reported device performance: These are not defined in the context of clinical outcomes within this document. The "performance" mentioned refers to bench testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No clinical test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: This device is a physical medical device (a stent and delivery system), not an AI/software device. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for the clinical performance criteria you are asking about. The "ground truth" for the bench tests would be the established engineering specifications and standards.
8. The sample size for the training set: Not applicable, as there is no training set for a clinical algorithm.
9. How the ground truth for the training set was established: Not applicable.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that the submission includes Performance Bench Testing and Biocompatibility Testing. These are standard tests for physical devices to ensure their safety and physical functionality, not their clinical effectiveness in terms of patient outcomes or diagnostic accuracy.

In summary, the provided document is not a study report that demonstrates clinical performance against acceptance criteria for patient outcomes or diagnostic accuracy.

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The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers are intended for delivery of the stent to the pancreatic duct (PD):

• Used to drain pancreatic ducts

The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers product consists of pancreatic stents and delivery systems or stent pushers.

The pancreatic stents are provided in straight or single pigtail shapes. The straight shape stents have trailing barbs and/or leading barbs depending on application, a rounded or tapered leading end tip to facilitate access through the papilla, and a rounded trailing end to abut the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on the application. Some stents have lateral drainage holes in the pigtails, a tapered or rounded leading end tip, and a rounded trailing end.

All stents have either an endoscopic marker, fluoroscopic marker, or both on the trailing end of the stent to assist with depth of placement in the pancreatic duct. The location and presence of an endoscopic or fluoroscopic marker are dependent on the length and diameter size of the stent. Some codes have side port holes in the body of the stent.

This K223592 submission is for a Special 510(k) to update the MRI safety information in the product labeling of the Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers. The device itself is identical to its predicate, and therefore, an extensive clinical study to prove device performance in terms of its intended use (draining pancreatic ducts) was not conducted. Instead, the "acceptance criteria" and "study" described below relate specifically to demonstrating compliance with updated FDA guidance for MRI safety labeling.

Here's a breakdown of the requested information based on the provided document:

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)

This submission does not involve human or animal test subjects for its performance evaluation focusing on MRI safety. The "test set" would consist of the specific configurations and sizes of the Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers that were subjected to the bench testing described. The document does not specify the exact number of devices tested, only that "Performance testing (bench) was completed." The data provenance is laboratory bench testing, not from any specific country or retrospective/prospective study with patients.

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)

This is not applicable to an MRI safety bench testing study. The "ground truth" for these tests are the established standards and methodologies outlined in the ASTM documents. Compliance is determined by whether the device's behavior during testing falls within the specified parameters of the ASTM standards, not by expert consensus on clinical outcomes.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert review is needed to establish ground truth from patient data. This submission relies on standardized physical measurements and engineering evaluations.

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 device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This device is a medical implant and delivery system, not an algorithm.

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

The "ground truth" used for this submission is based on accepted engineering and physics principles as codified in specific ASTM standards for evaluating medical devices in the MR environment. These standards dictate acceptable limits for displacement force, torque, heating, and artifact generation.

8. The sample size for the training set

Not applicable. Since no AI/ML algorithm is involved, there is no training set.

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

Not applicable. No training set was used.

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